CCRA Certified Clinical Research Associate 3 — Questions and Answers
Question 1: A subject who previously signed informed consent now lacks decision-making capacity due to an adverse event. Who may provide continued consent for their participation?
- The site coordinator may re-consent on the subject's behalf
- A legally authorized representative (LAR) as defined by applicable law (Correct answer)
- The principal investigator may waive further consent
- The IRB must re-consent the subject at the next meeting
Correct answer: A legally authorized representative (LAR) as defined by applicable law
When a subject loses capacity, a legally authorized representative defined by applicable law and IRB-approved procedures may provide surrogate consent.
Question 2: Which ICH E6(R2) addendum concept introduced the idea of proportionate monitoring based on risk?
- Central monitoring replacing all on-site visits
- Risk-based monitoring (RBM) focusing oversight on critical data and processes (Correct answer)
- Source data verification of 100% of CRF entries
- Elimination of the Trial Master File requirement
Correct answer: Risk-based monitoring (RBM) focusing oversight on critical data and processes
ICH E6(R2) introduced risk-based monitoring, directing CRA resources toward critical processes and data that have the greatest impact on subject safety and data integrity.
Question 3: At a closeout visit, the CRA instructs site staff on document retention. According to ICH E6 and FDA regulations, trial records must generally be retained for a minimum of how many years after the last approval of a marketing application?
- 2 years (Correct answer)
- 5 years
- 10 years
- 15 years
Correct answer: 2 years
FDA 21 CFR 312.62 requires investigators to retain records for at least 2 years after the last approval of a marketing application or 2 years after the investigation is discontinued.
Question 4: A CRA identifies that a site has been using an outdated version of the informed consent form for the past three months. What is the appropriate classification of this finding?
- A minor protocol deviation requiring no action
- A serious protocol deviation because it may have affected subject rights (Correct answer)
- An adverse event that must be reported to the FDA
- A GCP violation that requires immediate trial termination
Correct answer: A serious protocol deviation because it may have affected subject rights
Using an outdated informed consent form is a serious protocol deviation because subjects may not have been informed of updated risk information, potentially affecting their rights and safety.
Question 5: What is the purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To manage the randomization schedule for the sponsor
- To independently monitor accumulating trial data and recommend stopping or modifying the trial if warranted (Correct answer)
- To perform source data verification at investigative sites
- To approve all protocol amendments before they are implemented
Correct answer: To independently monitor accumulating trial data and recommend stopping or modifying the trial if warranted
A DSMB is an independent committee that reviews accumulating efficacy and safety data and can recommend trial modifications or early termination to protect subjects.
Question 6: According to 21 CFR Part 50, which of the following elements is REQUIRED to be included in an informed consent document?
- The names of all competing investigational products
- A description of any reasonably foreseeable risks or discomforts (Correct answer)
- The investigator's salary for conducting the research
- A listing of all FDA-approved therapies for the condition
Correct answer: A description of any reasonably foreseeable risks or discomforts
21 CFR 50.25 requires informed consent documents to describe reasonably foreseeable risks or discomforts to the subject.
Question 7: A sponsor-CRA learns that an investigator has not reported a serious adverse event (SAE) to the IRB within the required timeframe. What must the CRA do?
- Report the SAE to the IRB directly on behalf of the investigator
- Document the finding, notify the investigator of the obligation, and escalate to sponsor management per the monitoring plan (Correct answer)
- Close the site immediately and notify the FDA
- Amend the protocol to remove the SAE reporting requirement
Correct answer: Document the finding, notify the investigator of the obligation, and escalate to sponsor management per the monitoring plan
The CRA must document the deviation, remind the investigator of their reporting obligation, and escalate to sponsor management as specified in the monitoring plan.
CCRA Certified Clinical Research Associate 3
A subject who previously signed informed consent now lacks decision-making capacity due to an adverse event.
Who may provide continued consent for their participation?