ACRP CCRC Exam Prep 2024 Questions and Answers.
What are expected or possible consequences of over-estimation of recruitment
potential? - Answer - The
... [Show More] trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
What should be the first consideration when conducting a clinical trial? - Answer
Subject welfare
When is the investigator allowed to deviate from the protocol? - Answer When there
is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an immediate hazard to a
patient, according to ICH E6 guidelines who world they need to report the deviation
and rationale to, if appropriate? - Answer - The Sponsor
- IRB/IEC
- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject into your trial? - Answer
- Subject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP. The study drug
must be stored below 25C/77F. On a summer Monday morning you discover that the
temperature recording machine in the storage room has failed so you doin't know
what the temperature has been over the weekend. You check the current
temperature; it's 24C/75F. What should you do? - Answer - Contact the Sponsor,
explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received IRB approval for the
amendment and wants to implement the increase in PO dose for your trial subjects
as identified in the amendment trial subjects. As delegated consenting duties you
must re-consent trial subjects before being able to administer the adjusted dose. You
decide to only re-consent trial subjects who are still taking the IP and not from the
subjects woh already completed their drug intake period. Is this allowed according
the E6 Guideline for GCP? - Answer No, these subjects are still enrolled in the trial
and therefore need to be updated on any changes to the protocol.
A trial subject informs you she no longer wants to participant in the trial. What should
your course of action be? - Answer You ask if the patient wishes to share the reason
why she wants to leave the trial. If not, you exclude the subject from the trial
immediately.
A patient cannot recall the name of the heart condition medication he took a few
years ago. This is important information for deciding whether the patient may be
ACRP CCRC Exam Prep 2024 Questions
and Answers
enrolled in a clinical trial (IC/EC). What's your best course of action? - Answer You
attempt to retrieve the patients medical history by contacting previous caregivers and
you wait for additional information before enrollment.
Who has ultimate trial responsibility for each subject? - Answer The principle
investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be
reported to the IRB? - Answer No
What statements are true concerning an adverse drug reaction? - Answer - All
noxious and unintended responses to a medicinal product related to any dose should
be considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - Answer - Any AE
that results in death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
During a study visit a patient tells the investigator that she visited an emergency
room and received intensive treatment for allergic bronchospasm. Since the patient
was in the emergency room for only three hours, the investigator did not assess the
event as serious. Is this a correct assessment? - Answer No, this would be a
medically important event and should be considered serious
What data points minimally need to be reported by the site when reporting an SAE,
so that the sponsor can process the event? - Answer Identification of event, product,
and trial subject
During a visit with investigator, a subject reported feeling heart palpitations for a brief
period of time during the previous evening. The heart palpitations resolved without
reoccurrence. The investigator considered these symptoms to be unrelated to study
drug. The next day, the subject told a fellow student that he felt tired and was
planning on taking a nap. Later, the subject was found dead. A preliminary report
from the medical examiner indicated the subject died of pulmonary embolism. What
should your next course of action be? - Answer - Record these events in case report
form
- Immediately notify sponsor about serious adverse events
When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in
12/2013. Is the sponsor correct in only holding the investigator accountable for their
late reporting? - Answer No, the sponsor should support the conduct QC activities
with the sites to help them ensure timely SAE reporting.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The
investigator considers this event possibly related to the study drug even though this
is not listed in the IB as a potential adverse reaction. What would the investigator
report this event to the sponsor as? - Answer An unexpected, serious adverse event
A 22y/o male was entered into a clinical study for treatment of schizophrenia The
study drug was administered orally, BID. One week later, the subject visited the
investigator complaining of sever sore throat. The IB lists this as an occurrence
reported by 1% of subjects receiving drug. How should this severe throat be
classified? - Answer - An adverse event
- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true? - Answer - All ADRs
are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions is an AE
-Preplanned hospitalization is usually not an SAE
What determines the causality of an adverse event? - Answer The investigator
Which term best describes the cyclical process that involves the Plan, Do, Check,
Act activities? - Answer Quality improvement
Which term best describes an independent assessment of completed work to ensure
it will meet applicable quality standards? - Answer Quality assurance
Which term best describes the activities done to ensure quality output? - Answer
Quality control
Which term requires structure and a definition of acceptable standards of
performance? - Answer Quality planning
Which is represented in ALCOA-C? - Answer Attributable. [Show Less]