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SoCRA Certification Exam 2023 with complete answers
Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those fea... [Show More] tures and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR, Sec. 11.3) Electronic Record Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (21 CFR, Sec. 11.3) Electronic Signature A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3) Open system An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3) Clinical Investigation Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR, sec. 50.3) Investigator An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR, sec. 50.3) Sponsor A person who initiates a clinical investigation but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than the individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (21 CFR, sec. 50.3) Sponsor-Investigator An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3) Handwritten Signature The scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3) Act The Food, Drug and Cosmetic Act, as amended. Human Subject An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. (21 CFR, sec. 50.3) Institution Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3) Institutional Review Board (IRB) Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act. (21 CFR, sec. 50.3) Test Article Any food or drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351, and 354-360F of the Public Health Services Act. (21 CFR, sec. 50.3) Minimal Risk Means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3) Legally Authorized Representative An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3) Family Member Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship. (21 CFR, sec. 50.3) Assent A child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3) Children Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3) Parent A child's biological or adoptive parent. (21 CFR, sec. 50.3) Ward A child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3) Permission The agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3) Guardian An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes research. (21 CFR, sec. 50.3) Emergency Use The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102) IRB Approval The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal Requirements. (21 CFR, sec. 56.102) Contract Research Organization A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3) IND An investigational new drug application. Is synonymous with "Notice of Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3) Independent Ethics Committee (IEC) A review panel the is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3) Custom Device A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. (21 CFR, sec. 812.3) Implant A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (21 CFR, sec. 812.3) Investigational Device A device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3) Monitor When used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of and investigation. When used as a verb, means to oversee and investigation. (21 CFR, sec. 812.3) Noninvasive diagnostic device or procedure One that does NOT 1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. (21 CFR, sec. 812.3) Significant Risk Device An investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3) Termination A discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device A device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Unanticipated Adverse Device Event Any serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application. (21 CFR, sec. 812.3) Department of Agency Head The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. (45 CFR, sec. 46.102) Legally Authorized Representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research. (45 CFR, sec. 46.102) Viable As it pertains to the neonate, means being able after delivery to survive. Human Subject A living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102) Certification The official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102) Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Applicable Regulatory Requirements Any laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4) Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP E6 1.6) Audit Certificate A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11) Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13) Comparator (Product) An investigational or marketed product (i.e. active control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14) Compliance Adherence to all the trial related requirements, GCP requirements and the applicable regulatory requirements. (ICH GCP E6 1.15) Confidentiality Prevention or disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16) Contract A written, dated and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and if appropriate on financial matters. (ICH GCP E6 1.17) Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18) Coordinating Investigator An investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Contract Research Organization (CRO) A person or an organization (commercial academic or otherwise) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20) Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6 1.21) Documentation All records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22) Essential Documents Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E6 1.23) Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected. (ICH GCP E6 1.24) Independent Data Monitoring Committee (IDMC) May be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. (ICH GCP E6 1.25) Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's LAR cannot read, and who reads the informaed consent for, and any other written information supplied to the subject. (ICH GCP E6 1.26) Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, national or supranational), constitutes fo medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among, other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigators, facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27) Inspection The act by a regulatory authority of conducting and official review of documents, facilities, records and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6 1.29) Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of the trial. (ICH GCP E6 1.32) Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trail, including a product with a marketing authorization when used or assembled in a different way from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH GCP E6 1.33) Investigator's Brochure A compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational products in human subjects. (ICH GCP E6 1.36) Legally Acceptable Representative An individual or juridicial or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects participation in the clinical trial. (ICH GCP E6 1.37) Monitoring Report A written report from the monitor or sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. (ICH GCP E6 1.39) Multicentre Trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH GCP E6 1.40) Nonclinical Study Biomedical studies not performed on human subjects. (ICH GCP E6 1.41) Protocol Amendment A written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45) Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with Good Clinical Practices and the applicable regulatory requirements. (ICH GCP E6 1.46) Quality Control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. (ICH GCP E6 1.47) Randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH GCP E6 1.48) Regulatory Authorities Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data. Form 1572 Statement of investigator for IND Form 1571 Cover sheet for an IND application Private Information - information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place - information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record) IRB membership requirements according to 45 CFR 46 - minimum of 5 members - IRB must be qualified through experience, expertise, diversity - diversity with respect to race, gender, cultural background - cannot consist of members of one profession - at least one member must have a primary concern in a scientific area and one in a non-scientific area - at least one member not affiliated with the institution Circumstances/conditions required for informed consent - subject has had sufficient opportunity to consider whether to participate - the possibility of coercion or undue influence is minimized Informed Consent MUST Contain: - explanation of purpose of research - duration of participation - description of procedures to be followed - identification of any procedures which are experimental - any foreseeable risks or discomfort - statement about potential benefits to subjects - statement if no reasonable alternative procedures or treatments are available to subjects - for > minimal risk, a statement about compensation and if medical treatment is available for injuries - statement of who to contact in the event of research-related injury Informed Consent ADDITIONAL Elements: - risk to embyro or fetus - termination procedures - costs to study subjects - approximate number of study subjects - a statement of new findings when they may impact a subject's willingness to participate Oral consent - requires a witness - subject must sign short form only - witness must sign both short form and summary of what was said Waiver of Signed Informed Consent - if the only record linking the subject to the research would be the consent document and the principal risk would result from breach in confidentiality - the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the context of research Types of federally-funded research that may be done using prisoners as subjects - possible causes, effects, and processes of incarceration and criminal behavior - prisons as institutional structures or prisoners as incarcerated persons - conditions particularly affecting prisoners - practices aimed at improving the health or well-being of prisoners 3 regulatory agency sponsors of ICH European Union, Japan, United States What ethical standards are the ICH document based on? Declaration of Helsinki What special population must the IRB pay special attention to? Vulnerable subjects What 5 classes of products do the informed consent regulations apply? (test articles) - drugs - medical devices - biological products - electronic products - food (including dietary supplements and infant formulas) - color additives Minimum risk the probability and magnitude of anticipated harm or discomfort are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Form 3454 Certification of financial interest and arrangements of clinical investigators Form 482 Notice of inspection Form 483 Inspectional observations Form 3500 Voluntary safety reporting of adverse events and product problems Form 3500A Mandatory safety reporting by user facilities, distributors, and manufacturers Form 3455 Disclosure of financial interest and arrangements of clinical investigators 21 CFR 312 IND [Show Less]
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SOCRA Certification Exam with complete top solutions,A+ test
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? Yes (although permission to use such e-sigs... [Show More] has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? Yes Open system (FDA term) System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data into CHOP - controlled databases) Closed system (FDA term) Environment in which SYSTEM ACCESS is controlled by the same people responsible for the content of the system (I.E. I control the Robotic Database access AND its contents) What are some FDA Standards to meet when operating a closed record system? 1. Must be able to tell if records have been altered or invalid 2. Must be able to copy records for agency review 3. Protect records throughout retention period 4. Limit system to authorized individuals only 5. Use time-stamped audit trails of modification etc 6. Use operational system checks and restrictions 7. Use authority checks to make sure only authorized individuals are using the system 8. Use device checks to validate data input 9. Make sure those authorized to use system have appropriate training, education, experience 10. Have written policies that deter data falsification 11. Audit and control the maintenance of the actual system What are some FDA standards to meet when using an Open System? All those mentioned for the closed system. 1. Document encryption as appropriate What information should a handwritten SIGNATURE block contain? 1. Printed name of signer 2. Date and Time when signature was executed 3. The MEANING associated with the signature (approval? responsibility? authorship?) Signature and record linking ? Signatures must be linked to their respective electronic records to make sure they cannot be copied, falsified, transferred etc. Do researchers need to request permission from the FDA to use electronic signatures in place of regular signatures? Yes What controls should an E-SIGNATURE contain? Employ at least 2 identification components - such as an identification code AND a password. Name some CONTROLS for the identification components (i.e. identification code and password) for e-signature? 1. no 2 people should have the same identification controls (password... code) 2. Identification codes and passwords should be periodically checked, revised, etc. 3. Deauthorize lost, stolen, missing codes and passwords 4. Periodically test your devices that generate these codes Can an informed consent contain exculpatory language? NO! Cannot say things like "you are waiving your right to damages" etc When may an experimental drug or device be used on a patient WITHOUT informed consent? ((EMERGENCY USE)) 1. the investigator and an independent physician agree that the patient is -life threatening situation -informed consent cannot be obtained - there is no time to obtain consent from th esubject's legal representation -there is no recognized therapy that provides equal or greater likelihood of saving life - within 5 working days this must be evaluated by another independent physician -documentation must be submitted to the IRB within 5 working days -the president can authorize use on the military (lots of information on this military stuff..) When is it okay to skip informed consent and perform ((EMERGENCY RESEARCH))? 1. Human subjects are in life threatening danger, available treatments are unproven or unsatisfactory, and collection of valid science is needed 2. Obtaining consent is not feasible -subjects can't consent due to medical state -can't feasibly get LAR consent in time -no reasonable way to identify ahead of time individuals who will be eligible for participation 3. Participation holds the prospect of direct benefit to subjects -animal/preclinical studies support it -risks are reasonable 4. could not practicably be carried out without waiver of consent 5. OTHER protective measures are in place (counseling, disclosure, disclosure to public, data monitoring committee ETC Name the 8 elements of INFORMED CONSENT 1. statement of research. purpose of research. duration of participation. procedures involved. identification of all that is experimental. 2. Risks and discomforts 3. Benefits 4. Disclosure of alternatives 5. Confidentiality 6. Compensation if injury 7. Who to contact 8. Statement of voluntariness ADDITIONAL: Costs, pregnancy, termination of participation, withdrawal consequences, disclosure of findings, number of subjects in the study. Clinicaltrials.gov statement. Short Form consent In the context of human subjects research, a written document stating that the elements of informed consent required by the Common Rule have been ORALLY presented to and understood by the subject or the subject's legally authorized representative When can children participate in clinical trials ? (conditions) 1. No more than minimal risk 2. Adequate assent of the child 3. Risk is justified by potential benefit 4. Risk is above minimal, but likely to yield knowledge about a disorder or condition. Not reasonably different from their expected medical course. Assent. Things to consider when soliciting ASSENT Age, maturity, mental capacity When is ASSENT NOT REQUIRED? Children cannot be reasonably consulted in this case. Benefit is so great. Minimal risk. Could not practicably be carried out without the waiver. When can WARDS be included? related to their status as wards, conducted in a setting (school) where most are not wards, advocate has experience to act in the best interest of the child (cannot be associated with study team) Within how many days can emergency use of a test article be reported to the IRB? 5 Do IRBs need to register with the federal government? Yes! Every IRB that reviews clinical investigations must register under HHS How many members are required to be on an IRB? 5 members, with varying backgrounds to promote complete and adequate review of researchj Do the members of an IRB have to represent adequate diversity of backgrounds, race, vulnerability? Yes Each IRB shall include atleast 1 _________ and atleast one _______ (3 categories) Scientific member and non scientific member. Institution affiliated and NON institution affiliated Man and Woman Do a majority of IRB members need to be present when reviewing protocols? I think so. And you definitely need one nonscientific person. Does an IRB have to write out its reasons for not approving an IRB? Yes. It must allow the investigators appropriate response. Does an IRB have to do a yearly continuing review? Review of research at intervals appropriate to the degree of risk, not less than once per year (I suppose this could mean modifications like CHOP) When can an IRB use an expedited review method? Research is no more than minimal risk OR minor changes to previously approved research What criteria must be met for an IRB to approve a study? -Risks are MINIMIZED -Risks are reasonable in proportion to benefits -Selection of subjects is equitable -Informed consent will be sought -Informed consent will be appropriately documented -Data will be monitored for subject safety -Adequate provisions to protect privacy and confidentiality -Additional safeguards are in place for vulnerable subjects -All research is in complianace with FDA part 50, subpart D Can an IRB suspend or terminate research? Yes. If unanticipated harm, or if researchers are not following IRB requirements How long are IRB records required to be maintained after completion of a study? 3 years (and accessible!). FDA can shut it down if IRBs are not keeping records appropriately Are there a lot of required documentations and records by the IRB? Yes. Lots of written procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc. Everything needs to be documented! Does the FDA have the power to shut down, stop studies, etc if an IRB is not operating in compliance? Yes! Can full on disqualify if they repeatedly dont comply. When does a research drug need an IND? If it can't be legally marketed or shipped, it needs an IND. If you're hoping for a label change or a new indication for use, it needs an IND. When does a research drug NOT need an IND? It is already legally able to be marketed. Your research doesn't aim to change label or current use. If it doesn't increase risk, or go in unstudied populations etc. Do you need an IND for a placebo drug? NO Do you need an IND for a UNLABELED indication of an approved product? No, and this is confusing to me. Do investigational new drugs need to be clearly labeled as such? Yes Can sponsors charge for an investigational drug? Yes, but it has to be regulated and approved by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be burdensome on the sponsor in order for them to charge for it. What are the three phases of investigational drug studies? Describe and provide average # of subjects. Phase 1 - initial introduction of IND into humans. Determine metabolism and pharmacologic actions, pharmacokinetics. 20-80 subjects. Phase 2 - Controlled clinical study to evaluate effectiveness for a particular indication. Determine short term side effects and risks. Several hundred subjects. Phase 3 - Gather additional information about safety and efficacy, needed to evaluate overall benefit-risk ratio. Hundreds to thousands of subjects. What does an Investigator's Brochure contain? Drug substance, formula, structural formula. summary of animal data, summary of any human data. Pharmacokinetics in animals/humans. Summary of safety and efficacy, risks and side effects (to the extent known) Is an IND application brief? No it needs a billion and one things, like a grant but way worse. Summarizing the state of the union on this drug across time and nations How does an SAE differ from an AE? SAE contains death, life-threatening state, inpatient hospitalization (or prolongation thereof), incapacity, birth defect. Do researchers need to submit annual reports updating the FDA on their IND? YES! lots of details needed. How soon after an IND is submitted can investigators begin their studies? 30 days What is a "clinical hold" in regard to an IND? Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. Why might a clinical hold be issued? unreasonable risk is posed to human subjects, investigators are not qualified, brochure is misleading, IND is not sufficient, reproductive toxicity, etc. OR approved for marketing by another study. OR shown to be ineffective. Can the FDA terminate an IND? Yes, for mostly the same reasons why they would impose a clinical hold Can an IND be deemed "inactive" but not "terminated"? Yes. if no subjects are entered for 2 years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status. Does the FDA spell out suggested meetings as well as dispute resolution for sponsors and investigators? Yes Who is ultimately responsible for the proper conduct of a study? Sponsor. They select monitors and investigators. Do investigators need to supply sponsors with a whole host of information, kind of like a grant application? Yes Who receives the investigator's brochure? Every participating clinical investigator How long does a sponsor need to keep records after a marketing application for a drug is approved? 2 years Can FDA inspect whenever they want? Yes i think so What are the responsibilities of the investigator? Uphold their investigator's agreement and conduct study according to plan. Obtain informed consent. What type of records to investigators need to keep, and for how long after marketing approval? Disposition of drug records, case histories. For 2 years. Who submits annual reports to FDA, the investigator or the sponsor? The sponsor. Who submits reports of SAEs, and to whom? The investigators report to the sponsor, and also to the IRB i think Can a clinical investigator be disqualified? Why might that be the case? Yes - if repeatedly or deliberately failed to comply with subparts, agreements etc, or falsified any information. Is there a different set of regulations when it comes to life-threatening / debilitating diseases for which no good alternatives exist? Yes, evaluate the risk-benefit ratio differently Can drugs be imported and exported for clinical trials? Yes, under specified circumstances and with proper review etc. Can the FDA "rely" on an "external" FDA in a multi-national trial? Yes - you can accept foreign IND's if they were conducted under GCP etc, if the FDA can validate the data, and also need to submit lots of regulatory stuff. Is an IND application automatically public knowledge? No, it can be if investigator's want it to be. expanded access The use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Requires an application. Can a special access be granted for small patient populations, i.e. orphan drugs, orphan conditions? Yes - special considerations. Do the policies of devices largely mirror the policies for investigational new drugs? Yes, mirrored closely Federal Regulations Part 45/46 Protection of Human Subjects - Protection of Public Welfare Federal Regulations Part 21 Electronic Records, Human Subjects (50), IRB, IND, Investigational Devices 04955D auth code smh What types ofhuman subjects research could be considered exempt from human subjects review/regulation? Schools, educational tests, unidentifiable subjects, benign behavioral interventions, secondary research, public services research, expedited review a review of study proposals that pose minimal risk to subjects; one or two IRB members participate What are requirements for waiver of informed consent? Minimal risk, and could not be practicably be carried out without the waiver When may fetuses or pregnant women be included in research? -pregnant animals and non pregnant people have already been assessed for risk -risk to fetus/pregnant women is less than direct benefit -there is minimal risk to woman and fetus -this biological knowledge can be obtained by no other means If benefit is EXCLUSIVE to the fetus, with no benefit to the pregnant woman, who needs to consent? woman and father (there are exceptions for rape, artificial insemination, death/disability, and unavailability) If there is no risk/benefit for the fetus, only a potential risk/benefit for mom, who needs to consent? pregnant woman only Are there protections for coerced abortion for research? Yes. You cannot compensate for a terminated pregnancy.The individuals doing the research cannot determine the viability of pregnancies or timing of terminations. When can nonviable and questionably viable neonates be included in research? preclinical/clinical studies have been conducted. -researchers have no role in determining viability -research enhances possibility of survival -biomedical knowledge cannot be obtained ANY other way If Nonviable neonates are included in research... what are some protections that limit the research that can be done on them? Cannot artificially maintain a heartbeat or vitals -cannot TERMINATE the heartbeat or respiration/ vitals -No additional risk to the neonate -biomedical knowledge cannot be obtained any other way For a nonviable neonate, who needs to consent? Both parents (exceptions for unavailability, rape, incest etc) IRB rules when prison research is involved majority of the IRB members can have no relation to the prisoners. A prisoner or prisoner representative with appropriate background must serve Name some protections against coercion in prison research Cannot affect his/her parole status. Cannot give advantages or compensation that would coerce. Subject selection must be equitable/random. When can research include prisoners? If it is RELEVANT to incarcerated peoples. Does the FDA define the term children in terms of years? No. A child is someone who cannot legally consent to treatments or procedures in research (defined locally) Describe some instances when children MAY be included in research. -Minimal risk -risk is small in comparison to direct anticipated benefit -NO OTHER WAY of obtaining this information -appropriate preclinical trials -yield knowledge about a disease or condition -adequate assent/consent in place When is assent not needed? -Children are incapacitated/not sound to assent -Benefit is so great to the child -minimal risk Are there instances in which both parents need to consent for a child to participate in research? YES. I suppose more than minimal risk? of course, there are exceptions Are there exceptions for parental consent when a child is neglected or abused? Yes When can WARDS be included in research? If the research is directly related to their status as wards. If they are part of a big group... like a (non-ward) school, where excluded them would be inappropriate What government office do IRBs register under? OHRP (office of human research protections) When an IRB submits appropriate information to OHRP and is registered, how long is their registration active for? 3 years FDA Notice Of Inspection (482) An FDA Inspector presents this form which details rights, policies etc when they arrive on-site to Inspect an organization FDA Inspectional Observations (483) Lists (negative) observations during an inspection. A copy has to be given to organization. This form should include recommended corrective action. The action CAN be taken immediately with the inspector. FDA Statement of Investigator (1572) Provided to Sponsor. This is the "Investigator's Agreement" that they will uphold stated practices and communications and record keeping. The investigator also submits qualification information about themselves. FDA Certification - Financial Interests/Arrangements of Clinical Investigators (3454) This is the form that certifies that investigators have NO financial conflict of interests exist. Certified! FDA Disclosure - Financial Interests/Arrangements of Clinical Investigators (3455) If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this form. FDA Voluntary Reporting of AEs and Product Problems (3500) voluntary reporting of Aes, probems, use errors. These are less serious AEs FDA Mandatory Reporting for use by User-Facilities, Distributors, Manufacturers (3500A) 3500A is MANDATORY and includes details of serious AEs that led to death or serious injury Which FDA reporting form can also be used by patients? 3500 (not life threatening) Quick Overview: BELMONT REPORT (year and summary) The Belmont Report is a summary of the agreements about ethics of human research from the Commission that was created by the 1974 National Research Act. These deliberations occurred in 1976. Quick Overview: NUREMBURG CODE A set of 10 ethical principles for human experimentation. Developed in 1947 as a result of trials held in Nuremburg, Germany for medical personnel involved in the Nazi biomedical experimentation/torture/murder in concentration camps. Quick Overview: DECLARATION OF HELSINKI A set of ethical principles for medical research on human subjects originally set forth in 1964. Developed by the WORLD MEDICAL ASSOCIATION (WMA) Quick Overview: ICH HARMONISED GUIDELINE FOR GCP GCP is international guidelines for conduct of TRIALS. Developed by an international health council in 1990s to harmonize international guidelines that were already put forth. Meant to faciliate clinical trials internationally, especially between US, EU, Japan, and Switzerland. It serves to both protect subjects AND to assure data quality / good practice. Quick Overview: Paperwork reduction act of 1995 The purpose was to reduce the Burden of paperwork held by the public (or people involved in trials). Basically, before you have people fill out forms... it HAS to be approved by Office of Management and Budget. Why is the Belmont report such named? The Commission created by the National Research Act held its deliberations at the Belmont Conference Center of the Smithsonian. Please name the 3 Broad Sections of the Belmont Report 1. Boundaries between Practice and Research 2. Basic Ethical Principles (there are 3) 3. Applications (there are 3) What are the 3 basic ethical principles outlined in the belmont report? Respect for Persons, Beneficence, and Justice What are the 3 "Applications" Outlined in the Belmont report? Informed Consent Assessment of Risk and Benefits Selection of Subjects How does the Belmont report distinguish between Practice and Research? Practice: Interventions SOLELY designed to benefit and individual, already have a reasonable expectation of success. Research: an activity to test a hypothesis, develop generalizable knowledge. Formal protocol and procedures defined. respect for persons treating persons as autonomous agents and protecting those with diminished autonomy (relates to children, prisoners, mental disability, respect for peoples opinions and judgements) Beneficence (Definition) Maximize possible benefits and minimize possible harms. Belmont Report: Justice fair balance between those who participate and those who benefit. (good distribution of BURDENS vs. Benefits) you can't study prisoners to benefit larger society (and other examples) What are the 3 important elements of informed consent, as outlined in the Belmont Report applications? Information, Comprehension, Voluntariness Describe the differences in information, comprehension, voluntariness Information is WHAT is presented. Comprehension is HOW it is presented (time, organization, layman's terms, simple english). Voluntariness is freedom from coercion and influence (like from powerful people/power imbalance/threats) How should selection of subjects be systematically approached? Adults before children, capable before incapable, free before unfree etc. Free from social, racial cultural biases. Why is the Nuremburg Code such named? Came about from the trials held in Nuremburg Germany to prosecute unethical human experimentation in concentration camps Describe (in brief) the 10 principles set forth by the Nuremburg Code 1. Voluntary Consent of the subject 2. Fruitful results unprocurable by other methods 3. Based on animal results and natural history 4. Avoid ALL unnecessary suffering 5. Cannot conduct study in which death or disability will reasonably occur 6. Degree of risk should NEVER outweigh societal benefit 7. Proper preparations and adequate facilities to protect subjects 8. Only conducted by scientifically qualified persons with the highest skill and care 9. Human subjects must be at liberty to bring the experimentation on them to an end 10. Investigator must terminate any experiment when he has probably cause to believe death, injury, or disability is likely Please order dec of helsinki, belmont report, and nuremburg code in chronological order 1. Nuremburg code (40s) 2. Dec of Helsinki (60s) 3. Belmont report (70s) Who is the target audience of the Declaration of Helsinki? Physicians Loosely describe the contents of the declaration of helsinki Contains a lot of information that the other reports have. Principles of consent, investigator qualification, use of placebo, post-trial provisions, honestly kind of all over the place. Protection of vulnerable subjects, etc. Contrast an adverse drug reaction with an adverse event AEs don't have to be related to the drug/intervention. For ADRs, there is some possibility they are related. Please name the 9 sections of the ICH GCP 1. Definitions 2. 10 original Principles of GCP 3. IRB 4. Investigator 5. Sponsor 6. Protocol 7. Investigator's Brochure 8. Essential Documents for clinical trials 9. Paperwork Reduction Act Please name the 10 Principles of GCP (can include amendments) 1. Conducted according to Dec of Helsinki ethics 2. Risks must be in proportion to benefit 3. Wellbeing of individual subjects is more important than anything 4. Information (clin and non-clin) on an investigational product must be thorough 5. Scientifically sound protocol 6. Approved by IRB 7. Investigators must be QUALIFIED 8. Every individual involved in a trial must be QUALIFIED 9. CONSENT 10. Accurate reporting, interpretation, and verification of data are crucial 11. Confidentiality protected 12. Good Manufacturing Practice for drugs/devices 13. SYSTEMS in place to assure quality and safety Is the IRB responsible for reviewing investigator qualifications? Apparently, yes. Along with research procedures. Are prorated compensation models more ethical than entire completion models? Yes! Good to know! Can't unduly coerce them to remain in the study Name 4 categories of EVENTS that require submission to the IRB 1. Protocol Deviations or Changes 2. Changes that increase risk 3. all Adverse Drug Reactions that are SERIOUS and UNEXPECTED 4. New information that may affect subjects/trial [Show Less]
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SOCRA Practice Test questions and answers with complete top solutions
Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest f... [Show More] orm? FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is 3500 Medical device adverse events/problems are reported via a form: 3500A What is FDA form 1571? Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with Investigational New Drug Application Investigational new drug means A new drug or biological drug that is used in a clinical investigation The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug—Limited by Federal (or United States) law to investigational use." Which of the following is not listed on FDA form 1571: Approved informed consent document "Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred" Is... Life threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? 1. Respect for Persons 2. Beneficence 3. Justice What are the applications for the Belmont Report? 1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects What phrase of a drug trial usually includes hundreds to thousands of volunteers? Phase 3: These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. What is a drug as defined by the FDA? A drug is an product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body. What is Phase 1 of a clinical trial? 20-80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY. What is Phase 2 of a clinical trial? 100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS What is Phase 3 of a clinical trial? 1000's :Typical number of patients used in Phase. 3. These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. What is Phase 4 of a clinical trial? Post Marketing: Because it's not possible to predict all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the market is critical. The role of FDA's post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed. The main concept of 21 CFR 50 is Protection of Human Subjects Subpart D of 21 CFR 50 lists the Additional Safeguards for children in Clinical Investigations The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subject a. true X (21 CFR 56.110 Subpart D) b. false A Phase ___ protocol is more flexible and less detailed than the others. Phase 1 A source document is any document found that is associated with a clinical trial. a. true b. false X (A source document is any document where the date are FIRST recorded) A sponsor will not ship a study drug until they have received all of the following documents: - IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials - Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572 - Current lab certifications and normal ranges Certification of absence of financial interest would also be known as: Form 3454 What is the minimum number of IRB members? 5 The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be? 77 The responsibility for ensuring that the investigator understands a clinical trial lies with the sponsor Significant risk device is defined as an investigational device that is: a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c. for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. Answer: All the above A purpose of monitoring clinical trials is to verify that: The rights, safety and well-being of human subjects are protected. A sponsor may transfer responsibility for any of all of the obligations to a Contract Research Organization (CRO) A contract research organization shall be responsible for : - Control of the Drug - Selecting Investigators - Obtaining information from the investigators The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for ____ following the study's completion. 1 year The contract research organization shall select a monitor that is ________________. -Qualified by experience - Qualified by training A ____ lists the investigator's education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation. 1. Curriculum vitae 2. Statement of qualifications of the investigator The sponsor shall monitor investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria for exception or because of other relevant eithical concerns a. true X b. false Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _______. Investigator Brochure ____ means the party who submits a marketing application to FDA for approval of a drug device or biologic product. Clinical Investigator The applicant must completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is a full-time or part-time employee of the sponsor for each covered clinical study. a. true b. false X - Must Disclose everyone, not just those who are full time or part time. What is an informed consent? What is informed consent? consent given by a patient to a procedure after understanding the facts and the risks What is 21 CFR 56.109 subpart C? IRB review of research 21 CFR 56 Subpart B is IRB documentation a. true b. False X - 21 CFR 56 subpart B is organization and personnel The form ___ is used for investigational new drugs (or IND) 1571 What is 21 CFR 50.25 Subpart B? Elements of Informed Consent The "Doctor's Trial" prompted the Belmont Report a. true b. false X What is 21 CFR 50.27? Documentation of informed consent The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU, Japan and the Untied States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions a. true X b. false In the preapproval clinical experience with a new medicinal project or its new usages, particularly as therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicianal product related to any dose should be considered ____ Adverse drug reactions, ADR _____ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Direct Access What is 21 CFR 50.53 Subpart D? Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalization knowledge about the subjects' disorder or condition - Children Who monitors the progress of all clinical trial investigations being conducted under its IND? The Sponsor What is 21 CFR 56.110 Subpart C? Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research The World Medical Association (WMA) ethical principals for medical research involving human subjects is called? The Declaration of Helsinki What is 45CFR46? HHS - Protection of Human Health Subjects What is 45 CFR 46 Subpart B? Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research When a short form is used for Informed Consent, the witness must sign either the short form or the summary a. true b. false X - the witness must sign BOTH the short form and the summary. The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is.. 21 CFR 11 Which of the following are necessary to satisfy 21 CFR 50.23 Subpart B? - There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject - The human subject is confronted by a life-threatening situation necessitating the use of the test article - Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from, the subject - Time is not sufficient to obtain consent from the subject's legal representative. What is 21 CFR 50.24 subpart B? Exception from Informed Consent Requirements for Emergency Research That is the minimum number of IRB members? 5 What is the federal department responsible for helping people of Canada maintain and improve their health? Health Canada The object of GCP is part of the ICH mission statement a. true X b. false A (n) _____ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject Case Report Form, CRF What do the HHS stand for? Department of Health and Human Services What is 21 CFR 50.20 subpart B? General Requirements for Informed Consent Requirements for Emergency Research When a short form is used for Informed Consent, the partient signs the short form ONLY and the receives a copy of both the summary and the short form a. true X b. false What is 45 CFR 46 subpart A? Basic HHS policy for Protection of Human Research Subjects This form is used for the voluntary reporting of adverse events and product problems 3500, FDA 3500 The Code of Federal Regulations that applies to investigational new drug application is: 21 CFR 312 What does 21 CFR 54 deal with? Financial Disclosure of clinical investigators A(n) ____ is an investigation or marked product, or placebo, used as a reference in a clinical trial. Comparator, Product What is the FDA form 3454? Certification - Financial Interests and Arrangements of Clinical Investigators What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function? CRO - Contracted Research Organization The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as Good Clinical Practice (GCP) What is 21 CFR 50/51 subpart D? Clinical investigations not involving greater than minimal risk- children - Remember that ALL sections under subpart D of 21 CFR 50 deal with children - the heading for all of subpart D is additional Safeguards for children in clinical Investigations What is 21 CFR 50.54 Subpart D? Clinical investigations not otherwise approvable that presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children. What is 21 CFR50 subpart D? Additional Safeguards for Children in Clinical Investigations The Code of Federal regulations that applies to the Protection of Human Subjects is 45 CFR 46 What are the three fundamental ethical principals for human subjects research 1. respect for persons 2. beneficience 3. justice The FDA form 483 is used for: Inspectional Observations A(n) ______ can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Adverse Event, AE What is 21 CFR50 subpart B? Protection of Human Subjects The IRB may, for some or all subject, waive the requirement hat the subject, or the subjects legally authorized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context a. true b. false X - The IRB may. for some or all subjects, waive the requirement that the subjects or the subject's legally authorized representative, sign a written consent form if it finds the research presents NO more than minimal risk. The IRB may not do this for research that is more than minimal risk. Which of the following is 21 CFR 56.106 Subpart B? Registration What is 21 CFR50.52 Subpart D? Clinical investigations involving greater than minimal risk, but presenting the prospect of direct benefit to individual subjects children Which of the following are necessary to satisfy 21 CFR 50.24 subpart B? - Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21 CFR 50.24 (a) - Obtaining informed consent not feasible - as described in 21 CFR 50.24 (a) - The clinical investigation could not practicably be carried out without the waiver. - The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions. - The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. What is the FDA form 482 for? Notice of Inspection This form is used for the mandatory reporting of serious adverse events 3500A, FDA form 3500A A significant risk device - Is intended as an implant and presents a potential for serious risk to health, safety or the well-fare of the subject. - Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety or the well-fare of the subject. - For use of the substantial importance of diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety or well-fare of the subject. What is FDA form 3455? ... What is 21 CFR 50.23 Subpart B? Exception from General Requirements What is 21 CFR50.55 Subpart D? Requirements for permission by parents or guardians and for assent by children Which of the following are considered BASIC elements of the informed consent under section 21 CFR 50.25 subpart B? - A description of any benefits to the subject or to others which may reasonably be expected from the research - An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and whom to contact in the event of research-related injury to the subject. - A statement describing the extent if any to which confidentiality of records identifying the subject will be maintained that notes the possibility that the FDA may inspect the records. - A description of any reasonably foreseeable risks or discomforts to the subject. - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject - A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. - For Research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and if so what they consist of or where further information may be obtained. - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed and identification of any procedures which are experimental. Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the... Mission statement of GCP Guidelines What is 45 CFR46 Subpart C? Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. Under 21 CFR312, this form is the statement of the investigator of a clinical trial 1572 [Show Less]
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SOCRA- 2023 100% accurate answers
Belmont Report was created as part of? The national Research Act of 1974. Who was the Belmont Report formulated by? The National Commission for th... [Show More] e protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? 1996 What is the National Research Act? A set of regulations for the protection of human participants in research, mandated by congress in 1974, which lead to the Belmont Report. What is GCP? Good Clinical Practice- Guidelines developed by the ICH for global implementation on April 30, 1996 EU, Japan, USA Australia, Canada, Nordic Countries and WHO. What is the purpose of ICH? International Conference of Harmonization- an attempt to streamline the process for developing and marketing new drugs internationally. *Eliminate duplicate research. What are the ethical standards the ICH documents are based off of? Declaration of Helsinki The ICH is concerned with harmonization of what three regions? European Union, Japan, USA. *Additional countries include: Australia, Canada, Nordic countries and WHO. Important ethical principals that were the result of experimentations in the concentration camps during WW||? Nuremberg Code The organization that developed the Declaration of Helsinki? World Medical Association. Who does the Declaration of Helsinki mainly address? Physicians Who is Peter Buxton? The journalist that leaked Tuskegee to the press. Who is Henry Beecher? The journalist that published a manuscript in the New England Journal of Medicine presenting evidence of wide spread unethical and systematic problems in research. How long did the Tuskegee Syphilis trials last? 1932-1972 The direct result of the Tuskegee Syphilis Trail of 1979. Belmont Report What two ethical works did the Nuremberg Code influence? 1. Belmont Report 2. Declaration of Helsinki Importance of the Belmont Report (1974)? Boundaries between Practice and Research. Basic Ethical Principals: -Respect for persons -Beneficence -Justice Applications: -Informed Consent -Assessment of risk to benefit - Selection of subjects The 1947 Doctor's Trial Judgment resulted in what? The Nuremberg Code Exempt Research Exempt from regulations described in the DHHS regulations. (46.104) Curriculum Vitae Also known as CV, statement of qualifications. (312.23) Oral Consent 1. Requires a witness. 2. Subject must sign short form. 3. Witness will sign short form and summary of what was said. (50.27) Unanticipated Adverse Device Effect Effecting safety/ health or any life- threatening problem or death caused by or associated to device. (812.3) Historical Controls Prior data from patients with a similar disease to be studied or data from the same patient in crossover study. Essential Documents Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (GCP) Digital signature An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (11.3) CAPA Corrective and Preventive Action Plans. *IRB can request one. They can also be done proactively. UPIRSO Unanticipated Problems Involving Risk to Participants or Others. SUSAR Suspected Unexpected Serious Adverse Reactions. Excipients Inactive substances used as a carrier for the active ingredients of a medication. Parallel Group A study design that focuses on efficacy and safety. Crossover A study design that focuses on bioequivalence, can also help determine if generic drugs are interchangeable. Pre- study Visit SQV's; also knows as: site selection visit, site qualification visit. Conducted to determined if the P.I. and clinical staff have the capacity to conduct a study. The P.I. and study coordinator must be present (at the very least), Pharmacy, if available. Initiation Visit SIV's Where the research team will get adequate training from the sponsor (or CRO) on the protocol. This usually happens after all regulatory documents have been collected and IRB approval has been obtained. Investigator meeting P.I and other study staff invited to participate to go over the study details to the sponsor/ CRO. Monitor Visits Periodic monitor visits help by the sponsor/CRO will developed (determined by the complexity and enrollment of the study) a monitor plan. Verification of how the study is being conducted is the main focus. The contract agreement will have the frequency and length of visits. Close- out visit Conducted at the end/ completion of a study. This can sometimes be included within final monitor visit. This visit is used to tie up lose ends. FWA Federal wide Assurance; the only assurance accepted and approved by OHRP for institutions engaged in non- exempt human subject research conducted or supported by HHS. This indicated that the institution commits to HHS that they will comply with 45CFR46. Inspection (ICHE6GCP) Conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Audit (ICHE6GCP) A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). *Audits always independent of the clinical trail. A.L.C.O.A-C Attribute: Who creates record and when. If changes, why, when and by who? Legible: Research record should be easy to read. Contemporaneous: Observance/ results recorded as is. Signature/initials should be accompanied by date. Original: No copies. Accurate: Integrity, honest, thorough and correct. Complete: adequate, accurate and complete source documents. IEC Independent Ethic Committee (312.3) When can expedited review be used? 1. A study involving no more than minimal risk. 2. On the DHHS and FDA specific list of categories. 3. Minor changes in previously approved research during the period for which approval is authorized *Only IRB chair or designated IRB member can conduct expedited review. (46.110) CRF A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. ICH E6 Guidelines for industry; GCP; Consolidated guidance ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Exempted Investigations A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time. *one example (812.2) PMA Premarket Approval Application (812) Class | Device 1. Present a low risk of harm 2. Subject to general controls. 3. Exempt from regulatory process. Ex. elastic bandages, tongue depressors. Class || Device 1. More complicated 2. Require special controls 3. most require a 501(k) Ex. CT scanners, powered wheelchairs Class ||| Devices 1. Sustain/ support life, implanted or present potential unreasonable risk of illness or injury. 2. Toughest regulatory controls 3. Most require a PMA Ex. Pace-makers, implanted weight- loss devices, breast implants. Compassionate use the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options; also called expanded access HHS Department of Health and Human Services (46.101) Research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (46.102) Office of Human Research Protection (OHRP) Concerned with protection of human research subjects *Publication in 2000 Clinical investigation !ny experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration. (50.3) Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (46.102) Quorum The minimum number of members who must be present to have IRB meeting. Controverted Issue An issue that causes a debate among the IRB members. Biometrics A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. (11.3) Exculpatory Language Made to wave or appear to wave a subjects legal rights (46.116) Phase ||| Studies 1. Efficacy 2. Safety Patient numbers: Serval hundred to several thousand. Phase | Studies 1. Safety 2. Tolerability *Dose- escalating, open- label, non- placebo controlled. Patient numbers: 20-80 Phase || Studies 1. Efficacy 2. Common short- term effects/ risks. *Double- blinded, placebo. Patient numbers: Several hundred. IND Investigational New Drug *Allows drug to be shipped over state lines. (312.3) Difference between applicate and sponsor? Applicate- sponsor requesting market approval Sponsor- sponsor conducting research. Transitional Devices A device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976. (812.3) Implant A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (812.3) Significant Risk Device An investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (812.3) Supplement Application For device studies send in for protocol modifications. *Similar to protocol amendments for drug studies. Open System An environment in which access is not controlled by the persons responsible for the content of electronic records that are on the system. (11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (11.3) IDE Permits a device that is not approved for marketing to be shipped lawfully over state lines. (812.1) HUD A medical device intended for the treatment or diagnosis of a disease that affects fewer than 8,000 individuals in the USA each year. *HDE- similar to IDE. Suspected Adverse Reaction any adverse event for which there is a reasonable possibility that the drug caused the adverse event. Relationship between drug and AE. The consent documentation differences between ICH and FDA ICH: Requires signature and date from both subject and person obtaining consent. Requires that subject receive copy of signed/ dated documents. FDA: Requires just date and signature of the subject. Requires that subject receive either a singed or unsigned copy of the consent. What guidelines do the DHHS Regulations provide? Ensure that the research plan makes adequate provisions for monitoring the data collected the ensure safety of the subjects. 21CFR314 New Drug Application (NDA). 21CFR814 Premarket Approval for medical devices (PMA). 21CFR11; Subpart B Electronic Records. 21CFR11; Subpart C Electronic Signatures. 21CFR50; Subpart B Protection of Human Subjects: Informed Consent of Human Subjects. 21CFR50; Subpart D Protection of Human Subjects: Additional Safeguards for Children in Clinical Investigations. *D for diapers 21CFR56; Subpart B IRB Organization and Personnel. 21CFR56; Subpart C IRB Functions and Operations. 21CFR312 INVESTIGATIONAL NEW DRUG APPLICATION. 21CFR812 INVESTIGATIONAL DEVICE EXEMPTIONS. 21CFR56; Subpart E IRB Administrative Actions for Noncompliance. 21CFR56; Subpart D IRB Records and Reports. 45CFR46 PROTECTION OF HUMAN SUBJECTS. 21CFR11 Electronic Records; Electronic Signatures. 45CFR46; Subpart A Basic HHS Policy for Protection of Human Research Subjects. *Also known as the "Common Rule, published in 1991. 45CFR46; Subpart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research. *B for baby 45CFR46; Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. *C for convict/ cell 45CFR46; Subpart D Additional Protections for Children Involved as Subjects in Research. *D for diapers 45CFR46; Subpart E Registration of Institutional Review Boards. 21CFR50 PROTECTION OF HUMAN SUBJECTS. *Also knows as "Common Law" 21CFR50.24 Exception from informed consent requirements for emergency research. Reporting; 312.32(IND safety reports.): Sponsor>>FDA/PI IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than 15 calendar days after the sponsor determines that the information qualifies for reporting. Reporting; 312.32(Serious and unexpected suspected adverse reaction.): Sponsor>>FDA/PI The sponsor must report any suspected adverse reaction that is both serious and unexpected in no case later that 7 calendar days. Reporting; 312.64(Safety Report): PI>>Sponsor An investigator must immediately (24Hrs) report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. Reporting; 812.150(Unanticipated adverse device effects): PI>>Sponsor An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect. Reporting; 812.150 (Unanticipated adverse device effects): Sponsor>>FDA/PI A sponsor who conducts an evaluation of an unanticipated adverse device effect under shall report the results of such evaluation to FDA and to all reviewing IRB's and participating investigators within 10 working days after the sponsor first receives notice of the effect. Reporting; 812.150 (Significant risk device determinations): Sponsor>>FDA If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working days after the sponsor first learns of the IRB's determination. 21CFR54 Financial Disclosure 21CRF56 INSTITUTIONAL REVIEW BOARDS The purpose of essential documents for the P.I. Demonstrate the compliance of the investigator, sponsor and monitor with standards of GCP and regulatory requirements. When can a P.I. implement change without approval of the IRB? Any time it would eliminate an immediate hazard to the trial subject. *Must be reported to IRB and FDA within 5 working days. Two GCP guidelines that should be followed by the P.I. 1. Inform subjects primary PCP about subjects trial participation. 2. Make a reasonable effort to understand the reasons a subject withdraws prematurely from a study. Once IP is received on site, who is responsible for it? The P.I. A subject that does not meet Inclusion/ Exclusion criteria but is approved by the sponsor, who else will need to approve before the subject may go on trial? IRB Form 1572 is legally binding between the P.I. and? The FDA What does the P.I agree to when completing a 1572? Personally will conduct and supervise the clinical trial. Form 482 FDA Notice of Inspection Form 483 Summary of observations from the inspection. 501(k) for devices A form used to demonstrate substantial equivalence to a legally marketed device. Form 1572 Under 21CFR312, this form is the statement of the investigator of a clinical trial. An agreement that the P.I will comply with the FDA regulations. Form 1571 Investigational New Drug Application Class || devices in market approval Premarket notification 510(k) for devices. Form 3455 Disclosure of financial interest and arrangements of clinical investigators *Bias **This form is completed by applicant/ sponsor. ***Also known as "financial Disclosure". Form 3454 Certification of financial interest and arrangements of clinical investigators. *non- bias Form 3500 Volunteer reporting of adverse events and product problems Form 3500A Mandatory safety reporting by user facilities, distributors, and manufacturers *All mandatory reports will have an A behind the number. Waivers of HIPAA authorization must be kept for how long? six years Actions the IRB can take when reviewing a study? 1. Approve 2. Approve; with conditions 3.Disapprove 4. Defer; pending major modifications. [Show Less]
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Socra CCRP exam questions and answers with complete top solutions
Contract Research Organization A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor... [Show More] 's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? False-they must sign both 00:52 01:41 What is FDA form 3454 Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the Belmont Report? Respect for persons. Beneficence. Justice. Phase III Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1 to 4 years Purpose: Efficacy and monitoring of adverse reactions Phase I 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Phase II Study Participants: Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Purpose: Efficacy and side effects The main concept of 21 CFR 50 is protection of human subjects 21 CFR 50 part D protection of childern A____________ can be any unfavorable and unintended sign) including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. adverse event The FDA form 483 is used for _______ Inspectional oberservation The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as GCP A(n) _________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial. comparator What is 21 CFR 50.23 Subpart B? the exception to the general requirements This form is used for the voluntary reporting of adverse events and product problems 3500 is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial direct access 21 cfr part b ICF Belmont Report (1979) respect for persons, beneficence, justice significant risk device s a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating A ________is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject crf sae form 3500a The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than _____ after the sponsor's initial receipt of the information 7 days Unexpected serious suspected adverse reactions and observations from animal studies suggesting significant risk to human subjects must be reported to FDA as soon as possible but no later than within __ calendar days following the sponsor's initial receipt of the information. 15 days the sponsor must notify FDA of any UNEXPECTED FATAL LIFE THREATENING SUSPECTED adverse reactions ASAP but no later than __calendar days following the sponsor's initial receipt of the information 7 days Follow-up IND Safety Report. Such report should be submitted without delay, as soon as the information is available but no later than __calendar days after the sponsor receives the information. 15 days What date should an investigator write when he failed to sign the consent form on the date of consent? date of investigators signature for MEDICAL DEVICE trials the P.I. should submit to the sponosr & IRB a report of any unanticapted adverse asap but no later than___ 10 days assent means a child's affirmative agreement to participate in a clinical investigation. consent from 1 or both parents or LAR is required. IRB exemptions can be made If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination use of the test article, must be submitted to the IRB and FDA in 5 days control group design eliminates bias double bllinded neither the subjects nor the experimenters know which subjects are in the test and control groups randomized double blilnded placebo-controlled trial of a medical treatment, some of the participants are given the treatment, others are given fake treatment (placebo), and neither the researchers nor the participants know which is which until the study ends single blinded only the participant does not know whether they are part of the treatment or control group, cross over design is a longitudinal study in which subjects receive a sequence of different treatments (or exposures). how long should essential clinical trial records be retained at site? 2 yrs after FDA approval or 2 years after study ended The records required by this policy shall be retained for at least _____and records relating to research which is conducted shall be retained for at least ___ years after completion of the research. 3 years changes in protocol A sponsor shall submit a protocol amendment describing any change in a Phase 1 protocol that significantly affects the safety of subjects or any change in a Phase 2 or 3 protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. class I General controls bandages, gloves, tongue depressors Class II general control+special controls (x-ray machines, monitors) Class III general controls+ premarket approval (pacemaker, diagnostic test, silicone gel breast implant) sponsor must discontinue the use of any investigational product that causes unreasonable risk to subjects and notify the FDA in 5 days sponsor must submit saftey report in ___after knowing of an event that meet reporting criteria 15 days Notify FDA within ___ of completion or termination of investigation 30 working days final report to FDA _____ after completion 6 months 3454 CERTIFICATION - Financial Interests/Arrangements of Clinical Investigator 3455 DISCLOSURE of Financial Interests/Arrangements of Clinical Investigator CAPA identify root cause or problem and how to solve them Primary Responsibilities of an investigator 1. oversee conduct of trial 2. protect the rights safety and welfare of subjects 3. control the use of investigational product Nuremberg Trials (1947) 1st set of principals outlining professional ethics for clinical research declaration Helsinki (1964) the World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants. Inspection of Clinical Trial Site investigators who conduct FDA regulated clinical are required to permit FDA investigators to access copy and verify any trial related records or reports ICF should be signed and dated 2 copies one for the subject or LAR another for the person obtaining the consent [Show Less]
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SOCRA CCRP Exam 2023 questions and answers
April 30 1996 ICH GCP Development Date Quality ICH Q 01:13 01:41 Efficacy ICH E Safety ICH S Multidisciplinary I... [Show More] CH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 Financial Disclosures 21 CFR Part 54 Institutional Review Board 21 CFR Part 56 IND Application 21 CFR 312 New Drug Application 21 CFR 314 Investigational Device Exemption 21 CFR 812 21 CFR Part 814 pre market approval of medical devices 45 CFR Part 46 Federal Research Studies that investigate the potential undesirable PD effects of a substance on physiological functions in relation to exposure in the therapeutic range or above Safety Pharmacology Studies (Pre-Clinical) 1) To Identify undesirable PD properties of a substance that may have relevance to its human safety. 2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology studies 3)to investigate the mechanism of the adverse PD effects observed and/or suspected Drug Development Safety Pharmacology Study Objectives (3) 1) Cardiovascular 2)Respiratory 3)CNS Three vital organ considered highest priority 1) PK and toxicokinetic 2) Single dose toxicity 3) Repeated dose toxicity 4) Local tolerance 5) Genotoxicity 6) Carcinogenicity 7) Reproduction toxicity 8) Supplemental studies if needed Types of Non-Clinical Studies (Animal Trials) Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target Primary Pharmacodynamic Studies Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target Secondary Pharmacodynamic Studies Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities Core Battery for Cardiovascular System Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) Core Battery for Respiratory System Motor activity behavioral changes coordination sensory/motor reflex response temperature Core Battery for Central Nervous System Investigational New Drug Application FDA Before clinical trials can be initiated, an application containing the appropriate information must be submitted to regulatory authorities, in the USA this is called XXXX and submitted to the XXX (21 CFR Part 312) Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug An IND permits what? (21 CFR Part 312) Assuring the safety and rights of subjects FDA's primary objective in all phases of development is... Phase II and III These phase of trials, the FDA helps assure the quality of the scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy (21 CFR Part 312) The FDA Who determines if Phase II/III studies are likely to yield data capable of meeting regulatory standards for marketing approval? 1) Novelty of drug 2)Extent the drug has been studied previously 3) Known of suspected risks 4) Phase of development IND information depends on the amount of information available, these 4 things are: (21 CFR Part 312) General Investigational Plan Protocols for specific human studies Initial IND should focus on (21 CFR Part 312) Build logically on previous submissions Be supported by additional information such as animal studies and other human studies Amendments to IND with new or revised protocols (21 CFR Part 312) Cover Sheet (FDA Form 1571) Table of Contents Introductory statement investigator's brochure protocol (s) Chemistry and manufacturing information pharm and tox information previous human experience with investigational drug A Sponsor Initiated IND must contain (21 CFR Part 312) 30 Days, unless FDA notifies sponsor of clinical hold Upon earlier notification, investigations may begin How long does it take for an IND to go into effect? (21 CFR Part 312) 1) To facilitate the availability of promising new drugs available to desperately ill patients as early in the drug development process as possible, before general marketing begins 2)To obtain additional data on the drug's safety and effectiveness The purpose of Treatment Use of Investigational Drug (21 CFR Part 312) 1) The drug is intended to treat a serious or immediately life threatening disease 2) No comparable or satisfactory alternative drug/therapy is available to treat the stage of disease in the intended patient population A treatment protocol or IND may be filed if: ((21 CFR Part 312) Phase II/ III trials or After all the clinical trials have been completed and the sponsor of the controlled clinical trial is actively pursuing marketing approval of the drug with due dilligence A treatment protocol or IND are usually found in what phase of trials? 30-Day Waiting Period How long is the waiting period before the study can initiate after the treatment IND is submitted? Need for investigational drug arises in an emergency situation Insufficient time to allow for submission of an IND or a treatment IND Request for specified use by telephone or other rapid means of communication Emergency use of an investigational product (21 CFR Part 312) 5 Working Days How quickly must a site notify the IRB of an emergency use of investigational drug? (21 CFR Part 312) 1) Notifying the FDA 2) Stopping all studies and notifying the investigators 3)All drug returned to the sponsor or destroyed as directed by sponsor 4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the IRBs of those reasons Sponsors have the right with withdraw an IND at anytime, without prejudice by completing the following: (21 CFR Part 312) An order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation What is a "Clinical Hold" Subjects may not be given the investigational drug What does a FDA "Clinical Hold" mean for a proposed study? no new subjects may be given the IP and subjects already taking the drug should be discontinued unless continuation is specifically permitted by the FDA What does a FDA "Clinical Hold" mean for an ongoing study? 1) Subjects exposed to unreasonable risk, illness or injury 2)Clinical investigators are not qualified 3)Investigator's brochure is misleading, inaccurate or materially incomplete 4)The IND does not contain sufficient information to assess risk to subjects Grounds for FDA Clinical Hold in Phase 1 Trials 1) All grounds related to holds in Phase 1 trials AND 2) The protocol is clearly deficient in design to meet the stated objects Grounds for FDA Clinical Hold in Phase II/III Trials 1) Initial Safety, dose escalation studies to determine MTD 2) PK and PD property, might be cross over design 3) Absorption, distribution, metabolism and excretion studies 4) Efficacy assessment, if possible Types of Phase I Trials 1) Initial demonstration of efficacy in subjects with the condition under investigation 2) obtain short term safety Goals of Phase II Trials 1) Confirmation of short term efficacy and safety 2) Establish long term efficacy and safety 3) Assess overall therapeutic value Goals of Phase III trials Phase III What phase of study usually has the largest number of subjects per study? Phase I What phase of study is usually single-center? Phase II/III What phases of stuides are usually multicenter? 1) Address FDA requirements for additional information not in NDA 2) Continue to assess overall therapeutic value 3)Surveillance for less common adverse events Goals of Phase IV Trials 1976 What year was the Medical Device Amendment? Medical Device Reporting 21 CFR Part 803 Investigational Device Exemption 21 CFR Part 812 Premarket Approval of Medical Devices 21 CFR Part 814 Quality System Regulations 21 CFR Part 820 Medical Device Classification Procedures 21 CFR Part 860 1) Achieve their primary intended purpose through chemical action within the body 2) Are dependent upon being metabolized for the primary achievement of the primary intended purpose Device definitions excludes what 2 type of products 1976, With Medical Device Amendments When was 510K Clearance Established? Clearance What is a 510k? 1) Required process of scientific review to ensure the reasonable safety and effectiveness of medical devices 2) FDA approval required before the device can be legally marketed Pre-Market Approval Requirements Lowest Risk, 510K often not required How do you define Class I Devices? Class I, II, III How are devices distinguished by risk? Moderate risk, usually requires 510k, might require PMA How do you define a device with Class II risk? Highest risk, PMA required How do you define a device with Class III risk? Elastic bandages, exam gloves, hand-held surgical instruments Examples of Class I devices 1) Prohibition against adulterated or misbranded devices 2) Premarket notification 510k requirements 3) GMPs 4) Registration of manufacturing facilities 5) listing of device types What are the general controls that provide reasonable assurance of safety for a device? Class I What type of device is sufficiently assured by general device controls? 1) Special labeling requirements 2) mandatory performance standards 3) post-market surveilance In addition to general controls, Class II devices are also subject to these types of special controls 1) Are usually those that support or sustain human life 2) are of substantial importance in preventing the impairment of human health 3)Present a potential, unreasonable risk of illness or injury Class III Devices Descriptions Replacement heart valve silicone-gel filled breast implants implanted cerebella stimulators implantable pacemakeres Examples of Class III Drugs Powered wheel chairs infusion pumps surgical drapes Examples of Class II devices Determined by the nature of the harm that may result to the subject in the study How is risk determined in device studies? 1) In an Implant 2)is used in supporting or sustaining life 3)is of substantial importance in diagnosing, curing, mitigating or treating disease or other prevents impairment of human health 4)otherwise presents a potential for serious risk to the health, safety, or welfare of a subject A Significant Risk (SR) Device Study is defined as: Does not meet the criteria for significant risk How do you define a non-significant risk device study? The sponsor, the IRB evaluates the determination Who makes the initial determination of SR or NSR? The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams and tests IRB definition of Minimal Risk Significant Risk Trials What type of device studies are subject to all IDE regulations (21 CFR Part 812) Non-significant risk trials What type of device studies are subject to abbreviated IDE regulations? (21 CFR Part 812.2b) Pilot Study Pivotal Study Types of Device Trials the shipment of a device for the purpose of conducting investigations of the device without complying without FDA requirements that would apply to devices in commercial distribution What does an Investigational Device Exemption (IDE) permit? 1)Legally marketable device in accordance with its labeling 2)diagnostic device complying with labeling requirements, testing is non-invasive 3)Does not require invasive sampling procedure 4)Does not introduce energy into subject 5) It is not used as a diagnostic procedure without confirmation by a medically established diagnostic product Devices can be granted IDE if: 1) Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device 2)if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application 2) any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects Definition of Unanticipated adverse device effect Unanticipated adverse device effect (UADE) What is the SAE counterpart in device trials? Investigational agreement What is used in device studies instead of a 1572? 5 Working Days, IRB and sponsor What time frame and to whom do sites have to report deviations from investigational plan in order to protect life or well being of patients on device trials? 10 Working Days, Sponsor and reviewing IRB What timeframe and to whom do investigators have to report UADEs? 5 Working Days (Sponsor and IRB) Notification time requirement for emergency use of investigational device Sponsor Who is responsible fore maintaining an effective IND or IDE? Sponsor Who is responsible for ensuring all investigators are conducting studies according to the general investigational plan and protocols in the IND? Sponsor Who is responsible for promptly reporting information about significant new adverse events or unanticipated adverse device effect with respect to the investigational product? Sponsor Who is responsible to terminate all studies if the product presents an unreasonable and significant risk to study subjects? Sponsor Who is responsible for selecting qualified investigators? Sponosr Who is responsible for providing information needed to conduct the study? Sponsor Who is responsible for selecting qualified monitors? 1) Medical Monitor 2) Data Safety Monitoring Boards 3) On-site monitoring What are three types of monitoring the sponsor is responsible for? Sponsor Medical Monitor Who is responsible for clinical oversight, evaluating safety information-trial wide? Data Safety Monitoring Board Who is responsible for periodic review of study data while study is in progress? On-Site Monitors Who is responsible for periodic site visits? 1) Manufacturing, packaging, labeling and coding of the investigational drug 2) Providing the investigational product only to investigators participating in an investigation 3)Maintain drug and device accountability records from manufacturing through use, return and destruction What are SPONSOR responsibilities with regard to IP? 1) Signed 1572 or investigational agreement 2)CV 3)Protocol 4) Financial disclosure What documents must be obtained from an investigator prior to study start? Sponsor Who is responsible for submitting safety reports to sites? Sponsor Who is responsible with providing pre-clinical and clinical study reports in the information amendments to the IND? Sponsor Who has the responsibility in submitting an annual report to the IND/IDE? Sponsor Who has the responsibility in maintaining quality assurance and quality control systems, with SOPs, for all activities? Sponsor Who has the responsibility to ensure the study is designed by qualified individuals? Sponsor Who has the responsibility to obtain an agreement from the investigator to adhere to the protocol, obtain IRB approval and GCP compliance? Sponsor Who is required to notify all parties involved, if warranted, of new safety information adversely affecting subject safety? During Marketing Applications When do sponsors have to submit summary forms of financial disclosures to the FDA? 1) Compensation affected by study outcome or in the form of equity interest in sponsor or compensation tied to sales 2)Significant equity interest in sponsor 3) Proprietary interest in tested product 4) Significant payments of other sorts to investigator or institution supporting activities of investigator What are 4 types of financial disclosures? All amounts What is the $ reportable amount for a financial disclosure if the amount is based on study outcome? All amounts What is the $ reported amount for a financial disclosure for proprietary interest in the test product? All amounts What is the $ reported amount for a financial disclosure for equity interest in the sponsor? >$50,000 What is the $ reported amount for a financial disclosure for equity interest in a publicly traded company? >$25,000 What is the $ reported amount for a financial disclosure for significant payments? Contract Research Organization Who may the sponsor transfer responsibility of duties or functions? Monitor Responsibilties ICH E6, Section 5.18 1) Verify the rights and well-being of human subjects are protected 2)Reported trial data are accurate, complete, and verifiable from source documents 3)The study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations What are the primary purposes for study monitoring? 1) The investigator's name and site location 2) date of the visit 3) monitor's name 4) site personell contacted 5)summary of what information was reviewed 6)significant findings and corrective action Written monitoring reports should include what elements? Investigator Responsibilities 21 CFR 312.60-70 Investigator Responsibilities ICH E6 Section 4 1572 What form documents investigator agreement to investigator responsibilities in drug trials? Maintain adequate and accurate records Investigator responsibilitiy 21 CFR Part 312.62 Make study records available for inspection 21 CFR Part 312.68 1) Inventory of product received by site, and date 2) Dispensing and return information for each subject 3)Specific protocol information like batch numbers, expiration dates, serial numbers, unique codes assigned to trial subjects Drug accountability records should contain: Single line through the error Enter correct information Initial and date the change Provide explanation if needed Do not obliterate error No erasures No white-Out How should source document corrections be made according to GCP guidelines? 1947 When was the Nuremberg code developed? 1) Voluntary consent 2) Fruitful results 3) Based on animal studies 4)avoid unnecessary physical or mental suffering 5)should not be conducted if death or disability will occur with a priori knowledge 6)humanitarian Benefits outweigh risk 7) proper facilities and preparation 8)conducted by qualified individuals 9)freedom to withdraw consent What did the Nuremberg code establish? 1964 When was the Declaration of Helsinki? Reiterated Nuremberg Code, "Informed Consent" obtained, design and performance of experiment procedure is clearly formulated in a protocol What did the Declaration of Helsinki accomplish? 1979 When was the Belmont Report? 1974 When was the National Research Act passed by congress? Boundaries between practice and research? What did the Belmont report establish? Interventions designed solely to enhance well-being of the patient with reasonable expectation of success How does the Belmont Report Define "Practice"? Activity designed to rest a hypothesis, draw a conclusion to develop or contribute to generalized knowledge How does the Belmont Report define "Research"? 1) Respect for persons 2) Beneficience 3)Justice What are the three principles of the Belmont Report? 1) treated as independent agents, those with diminished autonomy are entitled to protection 2) subjects enter into research voluntarily and with adequate information What does "Respect for Persons" entail? 1) Respecting decisions 2) Protecting from harm 3)securing well being: do no harm and maximize benefits while minimizing possible harm What does "Beneficence" entail? 1) Fairness, potential participants should be treated equally 2)Benefit of research not restricted to those who can afford it 3)Research should not involve persons from groups not likely to benefit from application of the research What does "Justice" entail? Informed Consent ICH E6 Section 4.8 Informed consent What must be obtained from the subject or LAR prior to initiating any research related exams? When there is no additional relevant information to provide to the subject? When is the informed consent process over? 1) Statement that includes the nature of the research, the purpose, duration, procedures and experimental procedures 2) Description of risks/discomforts 3) Benefits to the subjects or others 4)Alternative procedures or courses 5) Statement of record confidentiality 6) Compensation 7)Who to contact 8) statement that participation is voluntary What 8 ICF elements are required by 21 CFR 50 1) Risks to embryo or fetus 2) circumstances that might end trial 3)additional costs 4)approximate number of subjects 5)consequences of subject's decision to withdraw 6)significant new finding statement What additional elements can be included in an ICF, but not required? The Informed Consent Form What cannot contain language that waives or appears to waive the rights of the subject? The Informed Consent Form What cannot include language that releases or appears to release investigator, institution, sponsor or their agents from liability for negligence? [Show Less]
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SOCRA Exam Questions and answers with verified content
Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? False. The general provisions for electeonic... [Show More] signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider the electronic signatures, initials, and other general signing equivalent to full handwritten signatures, unless specifically excepted by regulations effective after August 20, 1997. True or False? True Electronic records cannot be used in lieu of paper records. True or False? False. Electronic records that meet the requirements may be used in lieu of paper forms, unless paper records are specifically required. provisions are subject to whose inspection? The FDA's inspection Provided they meet the requirements, persons can use electronic records lieu of paper records, for records required to be maintained, but not submitted to the agency. True or False? True. Persons can use electronic records in lieu of paper records for documents required to be submitted to the agency provided the document has been identified as a type of submission that the FDA will accept in electronic format. T or F? True. Documents submitted to the FDA that are not specified in the public docket as acceptable in electronic form, will not be considered as official if they are submitted in electronic form. T or F? True Who determines the details for electronic submission (e.g. methods of transmission, media, file formats and technical protocol)? The intended receiving agency unit will determine the details of electronic submission. In the FDA's regulations covering electronic signatures, what does the term Act refer to? Act means the Federal Food, Drug and Cosmetic Act. In the FDA's Electronic Signatures regulation, what does the term agency refer to? Agency refers to the Food and Drug Administration What is the term that means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions(s) where those features and/or actions are both measurable and unique to that individual? Biometrics What does the term closed system mean with regard to electronic records? Closed system means environment in which system access is controlled by persons who are responsible for the content of the electronic records that are in the system. An electronic signature is based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. T or F? False. This is the definition for the term digital signature. Any combination of text, graphics, data, pictorial, audio, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system is known as what? Electronic Record. Electronic signature and digital signature are synonymous terms. or F? False. Electronic signature means a computer data complilatiom of any symbol or series of symbols executed and authorized by an individual to be the legally binding equivalent of the handwritten signature. A digital signature is based upon cryptographic methods or originator authentication, a set of computed by using rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. What type of signature is the scripted name or legal mark of an individual preserved with a writing or marking instrument such as a pen or stylus? Handwritten signature How does open system differ from closed system with regards to the FDA's Electronic Records regulations? In an open system access is not controlled by persons who are responsible for the content of electronic records that are on the system Why is validation of systems an important procedure and control for closed systems? Validation of systems ensures accuracy, reliability, consistency of intended performance, and the ability to discern invalid or altered records The ability to generate complete and accurate copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency is a control established for closed systems. T or F? True. Closed systems are limited to authorized individuals only. T or F? True. 21. A procedure in place as a control for closed systems includes the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries. Changes made to the records may obscure and delete previous recorded information, so that the most current information, will always be accessible. T or F? False. Record changes shall not obscure previously recorded information. In electronic records, what do authority checks ensure? Authority checks ensure that only authorized individuals can use the system, electronically sign a record, access the computer system's input and output devices, alter a record, or perform other operations at hand. A control procedure for closed systems requires the determination that persons who develop, maintain or use electronic record/electronic signature systems have the proper training, education and experience to perform the assigned task. T or F? True. Persons or organizations desiring to use electronic records are not required to have written policies that hold individuals accountable and responsible for actions initiated under the electronic signatures, because the nature of electronic records does not permit falsification. T or F? False Persons who use open systems are not bound to any of the controls or procedures established by the closed system. T or F? False, What three elements are necessary for signed electronic records? a. The printed name of the signer b. The date and time when the signature was executed. c. The meaning of the signature (such as review, approval, authorship). Why is it necessary to link electronic signatures and handwritten signatures to the appropriate electronic records? Linking ensures that the signatures cannot be excised copied, or otherwise transferred to falsify an electronic record by ordinary means. [Show Less]
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SOCRA - CCRP (high level) questions and answers
Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene ... [Show More] / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed 01:13 01:41 Belmont Report (1979) Three core principles are identified: respect for persons, beneficence, and justice. Arose in response to Tuskegee Syphilis Study - studying untreated syphilis on African-American men unaware of their true condition and tx plan. Belmont Report - definitions of core 1. Respect for persons: informed consent + no deception 2. Beneficence: maximize benefits and minimize risk 3: Justice: fair procedures considering risk analysis. Belmont Report - current role Serves as a historical document and provides the moral framework for understanding regulations in the United States on the use of humans in experimental methods. Belmont Report - review of 7 items for research trials 1. IRB approved 2. Obtain informed consent 3. Ensure understanding 4. No coercion 5. Monitor adverse events 6. Maintain privacy 7. Ensure patients receive minimal care for their condition Declaration of Helsinki (1964, 1975) Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). GCP v Declaration of Helinski GCP lacks moral principles and guidance surrounding COI, study design, benefits, result reporting. Also restricts placebo in control group v effective alternative tx Common Rule US federal policy that specifies ethics regulations for human subjects research 1. ICF in reasonable language, reasons why they would not want to participate in research 2. Disclosure of use of de-identified data / specimens for future studies, commercial profit, clinically relevant results disclosed, genome sequencing 3. Consent waiver only if research could not be carried out without accessing / using information / specimens in an identifiable format. Pre-screening for trial permitted if able to obtain oral or written communication OR access records / stored biospecimens. 4. Exempt / Limited IRB if - record review both retrospectively AND propectively - benign behavioral interactions - collect identifiable sensitive data via adults in surveys/interviews 5. Continuing review - not required if expedited level 6. Multi-instituitional research studies required to use 1 IRB (effective 01-19-2020) Title 21 US Code of Federal Regulations (11, 50, 56, 312, 812) Title 21 is part of the code of federal regulations governing good and drugs for the FDA, DEA, and ONDCP (office of national drug control policy) 11 - e-records + e-signatures 50 - protection human subjects 56 - IRB that oversee trials 312 - drug trial requirements 812 - controlled substances Title 21 CFR Part 11 1. Controls - audits, validators, audit trails, e-sigs, documentation for software + systems processing e-data. 2. E-records cannot be illegible, inaccessible, or corrupted 3. "Hard copies" are authoritative documents for regulatory purposes Title 21 CFR Part 50 ... The National Research Act of 1974 Established the National Commission. Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy Henry K. Beecher Article (1966) Detailed 22 published medical studies presenting risk to subjects without their knowledge or approval. Beecher's article clearly demonstrated that unethical research was not confined to Nazi atrocities. U.S. Public Health Service (PHS) Study of Untreated Syphilis / Tuskegee Syphilis Study (1932-1972) Examined the natural course of untreated syphilis in Black American men. All were impoverished sharecroppers from Macon County, Alabama, were unknowing subjects in the study; they were not told that they had syphilis, nor were they offered effective treatment when it became available in the late 1940s with the availability of penicillin. Willowbrook studies (1956-1970) Children with intellectual disabilities were deliberately infected with the hepatitis virus Jewish Chronic Disease Hospital study (1963) Live cancer cells were injected into 22 cognitively impaired patients. National Research Act (1974) Congress passed this act in response to the concern on prior studies (PHS Syphilis, prisoner research, willowbrook etc) - est. National Commission to identify basic ethical principles + guidelines - required IRBs at organizations receiving funding The National Commission (1975-1978) Created recommendations for regulating human subject research - vulnerable populations, psychosurgery, IRBs, etc. Final report published 1979 - Ethical Principles and Guidelines for the Protection of Human Subjects of Research -> Belmont Report The Belmont Report Based on National Commission deliberations. 1. Respect for Persons 2. Beneficence 3. Justice Analytical framework guiding the resolution of problems arising from human subject research. Belmont: Respect for Persons Subjects are autonomous agents - informed consent If diminished autonomy, need additional protection. - Condition (age, health, cognition) - Circumstances (poverty, lack of education, social status) Also respect person's right to privacy (not directly addressed in Belmont). Belmont: Beneficence Strive to do no harm while maximizing benefits + minimizing harm. Systematic Assessment - account for probability and magnitude of potential harm Benefit - to individual or advancement of scientific knowledge Minimize risk - risks in research should be the minimum to achieve the research objective. Researchers + IRBs should carefully consider alternative, less risky procedures / modifications to reduced magnitude or probability of harm. Belmont: Justice Injustice is when benefit is denied from a person without good reason, and some the burden is imposed unduly. Example: research on prisoners or institutionalized children - both will not see the benefit and must bear the burden. Subject selection - are some selected due to availability, compromised position, or manipulatability? Must be based on scientific need, not convenience. Do not exclude so they do not derive benefit (i.e. not speaking english). Undue influences from real or perceived pressures - financial, power, implied benefits. 45 CFR 46 PHS policy raised to regulatory status for "Regulations for the Protection of Human Subjects of Biomedical and Behavior Research) in anticipation of the National Research Act. First set of federal regulations detailing requirement of organizational assurances, IRB review, ICF, and ethical conduct. Revised in 1981 21 CFR 50 + 21 CFR 56 Adopted by FDA on ICF in 1980, IRBs in 1981 respectively 21 CFR 812 + 21 CFR 312 Adopted by FDA in 1980 and 1981 for investigational medical devices + drugs & biologics respectively. 45 CFR 46, Subpart A 1991 - 17 federal agencies that conduct, support, or otherwise regulate human subjects research issued uniform regulations - "The Federal Policy for the Protection of Human Subjects." = Common Rule Updated -> 2018 Requirements: strengthen human subject protections, reduce administrative burdens, add flexibility. Major changes to IRB operations, ICF, definitions, and exemptions. Declaration of Helsinki International codes + standard in response to Nuremberg Trials 1964 - World Medical Assembly meeting in Helsinki Finland adopted "Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects." Has been revised multiple times (1975, 1983, 1989, 1996, 2000, 2008, and 2013). CIOMS guidelines International codes + standard in response to Nuremberg Trials 1982 - Council for International Organizations of Medical Sciences adopted "International Ethical Guidelines for Biomedical Research Involving Human Subjects". Revised in 1993, 2002, and 2016. WHO guidelines International codes + standard in response to Nuremberg Trials 2001 - World Health Organization (WHO) adopted "Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants." Designed to serve as international guidelines for the review + conduct of human subject research. ICH guidelines International codes + standard in response to Nuremberg Trials 1996 - International Conference on Harmonisation (ICH) brings together drug regulatory authorities and pharmaceutical industry of Europe, Japan, and the U.S. They adopted standards on Good Clinical Practice (ICH E6). ICH E6 details the responsibilities and expectations of all individuals - including researchers, monitors, sponsors, and IRBs. ICH E6 standards, while not part of any country's regulations, provide international standards for transnational pharmaceutical research. ICH renamed itself "International Council for Harmonisation" in 2015, added members, and in 2016 released a revised E6(R2) guideline. The FDA adopted the revised E6(R2) guideline as guidance. Presidential Commission report 1983 - Response on to further concerns regarding human subject research despite new regulations. Report raised concerns on adequacy of IRB review process. Office for the Protection from Research Risks (OPRR) (the predecessor to OHRP) at the National Institutes of Health (NIH) conducted multiple investigations of allegations of non-compliance with the regulations. Independent Reviews - General Accounting Office (GAO) & HHS Inspector General March 1996 and June 1998 respectfully GAO - IRBs overworks, competing demands, limited funds for inspections, complex research + large volumes HHS - reviewed too much too quickly with little expertise, minimal CR of approved research, little training. Are IRBs effective? Response to IRB concerns increased vigilance. OPRR began for cause and not for cause investigations. Did enact change, however then human subject Jesse Gelsinger died -> public outcry. Human Research Protections Program (HRPP) Response to issues with IRBs to further protect human subjects. Objective to assist in meeting ethical principles and regulatory requirements. Resulted in - Higher IRB standrads - Inc responsibility for researches - Inc requirements for COI - Accreditation requirements of HRPPs NBAC National Bioethics Advisory Committee (NBAC, 2001) Defines vulnerable subjects Deciding to use vulnerable populations requires: 1. To include vulnerable population? 2. Is it possible to do research without using the vulnerable population? Vulnerable population Populations at higher risk for: - Physical control, coercion, undue influence, manipulation. Federally, Due to: - children, prisoners, impaired decision-making, economically / educationally disadvantaged (45 CFR 46.111(b)) NBAC wishes to not categorize, but look at individual circumstances that may not allow them to give voluntary informed consent: - Cognitive / communicative, institutional, deferential, medical, economic, social IRB role and responsibilities - IRB's role, authority, and composition requirements are defined by federal regulations - review committee to help protect human subjects - approve, modify, disapprove, continuing review, material changes, observe, suspend / terminate approval -5+ members, varied background, 1 non-scientist, 1 scientist, 1 unaffiliated -Members must be qualified, knowledgeable and diverse HHS U.S. Department of Health and Human Services OHRP Office for Human Research Protections IRB Requirements - Risk / Benefit Analysis - ICF / Assent procedures + documentation - Subject Selection, include safeguards if research involved vulnerable populations - Privacy during recruitment and confidentiality during research - Plan for data collections, storage, and analysis (DSMB) - Design / Methods are scientifically sound - Additional - recruitment + safeguards Will also review: - PI qualifications + scientific collaborators - compliance w/ laws + regulations -IB + protocols (for FDA-regulated research) Type of IRB Review 1. Convened Committee Review - standard approach, for all new and greater than minimal risk research 2. Expedited Review - minimal changes to an approved study, no more than minimal risk & - IND / IDE not required - only collecting blood by sticks or venipuncture - noninvasive specimen collection - noninvasive procedures commonly done in clinical practice (no anesthesia or sedation, only FDA approved medical devices being used as marketed) - data collection / voice-video etc - individual group characteristic/behavior research -CR where enrollment is permanently closed with all subjected completed and is only in long-term follow-up -CR where no subjects enrolled with no additional risks -CR where study is only doing data analysis 3. Limited IRB Review of Select Exempt Categories - research education instructional strategies, techniques, curricula, or classroom management methods, which is not likely to adversely impact the student. - interactions for educational tests, surveys, interviews, or observations of public behavior & (1 or more) + privacy is kept with no identifiers + no liability to the subjects + identity can be ascertained by the investigator if needed. - Benign behavior interventions w/ data collection & (1 or more) + see above. Examples: board games, puzzles with various noises, etc. - Secondary research using private info / identifiable biospecimens & (1 or more) +knowledge is publicly available - Internal federal employee studies, contract/consulting arrangements, cooperative agreements, grants to better the public programs. - Consumer taste / food quality study - Broad consent to store / maintain identifiable private info / biospecimens for potential secondary research - Broad consent to use data/specimens for secondary research NOT Exempt: subjects prisoners, children, or observation of children with research participating in activities being observed. PI Recordkeeping PIs must keep signed consent documents, IRB correspondence, and research records for at least 3 years post trial. - sponsor/IRB may require longer. HHS Regulations 45 CFR 46 (Protection of Human Subjects 2018) applies to all human research submitted to or funded by HHS. Subpart A: Basic HHS Policy for the Protection of Human Subjects Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D: Additional Protections for Children Involved as Subjects in Research Subpart E: Registration of Institutional Review Boards NIH Regulations sIRBs be used for multi-site trials. All Phase III randomized clinical trials are to have DSMB/DSMCs Site FWA Federalwide Assurance (FWA) = compliance assurance is a written document submitted by an organization (not an IRB) that is engaged in non-exempt human subjects research conducted or supported by HHS. Site in non-exempt research + Subject to Common Rule Each IRB that is designated by an organization under an assurance of compliance approved for federal wide use by OHRP under 45 CFR 46.103(a) and that reviews research involving human subjects conducted or supported by the HHS must be registered with HHS. sIRB Single IRBs for multi-site trials. HHS regulations further require a reliance agreement between organizations that are relying and serving as sIRBs to include the responsibilities that each will undertake. Broad Consent Broad consent may be used as an alternative to informed consent for studies involving the storage, maintenance, and secondary research uses of identifiable private information and biospecimens. ICF Parts 1. This a research study aimed to X, expected to last Y years for X visits. Every 6 months you will come in for follow-up and an injection. 2. Risks 3. Benefits 4. Alt options 5. Confidentiality, if applicable FDA inspections 6. If greater than minimal risk - explain compensation / medical tx available in the event of injury. 7. Who to contact 8. Voluntary participation statement 9. Collecting identifiable information / identifiable biospecimens must include statement about use of future studies or will not be used for future studies. Legally effective elements as applicable include: 1. Possibility of unforeseeable risks 2. Subject participation terminated by the researcher 3. Costs to the subject 4. Consequences of withdrawing consent 5. Significant new findings will be communicated if it may relate to subject's willingness to continue 6. Approximate total number of subjects 7. Biospecimens (if de-identified) may be used for commercial profit and if subject will share in that profit. 8. If results will be disclosed and under what conditions. 9. Biospecimens if it will include whole genome sequencing 42 USC 282(j)(1)(A) A description of this clinical trial will be available http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. Qualifies as a clinical trial under the HHS definition and is subject to the Common Rule, there is an additional requirement to post the consent for to a publicly available federal website from 46.116(h). Until a special website is developed, or further guidance is provided, an option is posting the consent form for the trial to ClinicalTrials.gov or a docket folder on Regulations.gov (OHRP 2019). HHS Regulations for Waivers and Alterations 1. Government projects (public service like initiatives) 2. General waivers and alterations - no more than minimal risk - cannot be carried out w/o waiver - cannot be carried out w/o private info (if applicable) - will not adversely affect rights + welfare - subjects provided with pertinent info after participation (whenever appropriate) 3. Screening, recruiting, or determining eligibility ICF Exceptions - emergency research requirements are met - life-threatening with requirements for an exception met + documentation of (a). researcher + physician agree the situation calls for test article (b). subject/LAR unable to communicate (c). insufficient time to obtain consent (d). no alternative exists providing equal or better chance of survival Waiver of Signed Consent / Oral Consent FDA - minimal risk, no procedures HHS - + only identifiable link of subject to research would be the consent and principal risk would be breach of confidentiality. Subjects will be asked if they want consent to be documented. + minimal risk, no procedures + subject part of group/community where signing forms is not the norm, minimal risk, appropriate alternative mechanism to documents ICF obtained. LAR verbal telephone consent FDA - Fax ICF to LAR, review on phone, LAR returns faxed ICF to researcher HHS - does allow the exchange of consent information to take place face-to-face or by mail, telephone, fax, or video. An electronic format for the consent signature is also allowed. Electronic informed consent (eIC) video to demonstrate a study procedure, use of a tablet instead of a paper-based consent form, and use of electronic signatures HHS regulations also require that a written copy be given to the person signing the informed consent form. The copy could be in paper or an electronic format (Protection of Human Subjects 2018). SBR Social and Behavioral Research (SBR) Refers broadly to research that deals with human attitudes, beliefs, and behaviors. Biomedical and clinical researchers sometimes incorporate SBR questions and methodologies into their physiological research. SBR Methods Questionnaires Opinion data and other oral data Direct observation Data already collected for other purposes (such as records from education, healthcare, social service programs, employment, and insurance coverage) Non-invasive physiological measurement (such as skin impedance and pupil dilation as reflection of emotional arousal or attention). SBR Risks + Benefits Psychosocial stress + discomfort Physiological harms that are less predictable, more subjective, variable, and less remediable. Socio-cultural factors (i.e. collecting demographics of undocumented immigrants v citizens) Main risk tends to be breaches of confidentiality involving sensitive data SBR Data Management Code data, secure master list, secure environment, de-linking data from identifiers SBR Debriefing Distress or deception experiment design includes debriefing about information withheld at the end of their participation. Ex: debrief subject with a description of what really happened, explain why the research could not be conducted otherwise, issue an apology. *IF deceoption is used for benign behavioral intervention, research must inform the subject that they will be deceived before participating in research. Records-Based Research Hypotheses can be posed and answered by analyzing documented information in various types of paper or electronic records (such as medical, motor vehicle, criminal justice, or school records). Must: 1. Understand risks 2. Plan to minimize those risks 3. Obtain required approvals before conducting research Privacy defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) or information about oneself with others. *Low when patient gave IC, however much higher if records review without consent. Confidentiality pertains to the actual handling of the personal information once it is obtained. Risk Minimization Ethical and regulatory responsibility to minimize research risks to human subjects Common rule - research exclusions The Common Rule specifically excludes certain activities from the definition of research: - Scholarly or journalistic activities - Public health surveillance activities - Criminal justice activities (collection and analysis of information, biospecimens, or records) conducted for criminal justice purposes - Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions Is the research eligible for exemption from the federal regulations? Records-based research may be exempt if any of the following apply: 1. identifiable private info is publicly available 2. Info recorded in a manner that the subject cannot be identified (no contact, will se identifiers but will not record) 3. Research information for purpose of "health care operation" or "research" 45 CFR 164.501 - or "public health activities and purposes" - 45 CFR 164.512[b] 4. Federal dept/agency using gov't information for non-research activities 5. Identifiable private information used for secondary research in which broad consent was obtained + documented; waiver of consent obtained; IRB does limited IRB review to determine secondary research is within scope of broad consent + does not include returning individual research results to subjects unless legally required Expedited review? If the records review activity constitutes human subjects research, and does not qualify for exemption, it will then be subject to federal regulations. - no more than minimal risk - in expedited review category 5 (prospective / retrospective research using materials) limited data set If most, but not all, mandated identifiers are removed Family Educational Rights and Privacy Act (FERPA) Includes public kindergarten through twelfth grade (K-12) schools and postsecondary institutions Genomics v Genetics Genomics - DNA sequence in cell to biological function Genetics - inherited differences in DNA sequence between individuals + the effect of the difference in biological function if any Genetic & Genomic Research Risks - reveal predispositions to future disease, making information psychologically powerful + raising concerns of stigma/discrimination - Gene sequences shared by relatives, one person's genetic info provides information on their relatives who did not necessarily consent - Reveal ancestry conflicting with family / social / religious histories & beliefs - Genetic concepts + info have historically been misused to affect social/political ends Genetic Determinism controlling influence on human health, behavior, and disease. GWAS studies with WGS or WES GWAS = genome-wide association studies WGS = whole genome sequencing WES = only parts of genome coding for proteins (1% of entire DNA sequence) Large genomic studies by NIH requirements de-identify upload to central databases Maximizes use of information generated since studies are complex, difficult, and expensive Clinical v Research Information Many organizations do not segregate clinical and research information in electronic medical records. Is DNA truly able to anonymized? Yes In order to re-identify DNA sequence information, those attempting the re-identification must have a reference sequence that includes individual identifiers. That is, the DNA sequence is not intrinsically identifiable. While the risk of re-identification currently is low, it may increase with time due to technological developments. Therefore, research subjects should be told that there is a small risk of future re-identification of de-identified information or biospecimens. As with all research involving informational risks, researchers cannot guarantee complete confidentiality. To date, there are no instances of re-identification of data or specimens for illicit motives. Researchers who obtain access to some de-identified datasets, like the NIH database of Genotypes and Phenotypes (dbGaP) resource, are required to guarantee that they will not attempt to re-identify data. Any attempt to re-identify data or specimens would be a serious breach of research ethics unless explicitly authorized by an IRB for a critical purpose. Group privacy More broadly, some genetic research can produce discoveries about entire subpopulations, some of which correspond to racial or ethnic groups. Genetic Research ICF - lay language. - specimen storage & access information - if can be contacted about individual results - if a code can be used to re-link identity to samples - plan to develop commercial products or assays, and info about financial rights - future testing of samples. - future research studies, including those that may have a different focus. - if result (general, personal results, or incidental) will be returned to subjects. - yes/no to whole genome sequencing - commercial profit - sharing y/n - disclosure if clinically relevant results Managing incidental findings If the genetic analysis is likely to yield incidental findings, the study should describe plans for management of such findings. Management plans should include a description of the responsible individual that makes the determination of what results to return and who will inform the research subjects. Genetic Information Nondiscrimination Act (GINA) in 2008 GINA prohibits discrimination in healthcare insurance and employment based on genetic information. NIH Genomic Data Sharing Policy (2014) - Genomic data without associated phenotypic characteristics are available in an unrestricted fashion to the general public - Genomic data without associated phenotypic characteristics are available in an unrestricted fashion to the general public [Show Less]
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