Contract Research Organization
A person or an organization (commercial, academic, or other) contracted by the sponsor to
perform one or more of a
... [Show More] sponsor'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
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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]