RA Industry Best Practices 4 — Questions and Answers
Question 1: Which version of the informed consent form must be used when consenting a new participant?
- Whichever version is left in the supply drawer
- The sponsor's draft template
- The version the participant likes best
- The current IRB-approved version (Correct answer)
Correct answer: The current IRB-approved version
Using an outdated or unapproved consent version is a significant protocol and regulatory deviation.
Question 2: A participant cannot read but wants to join a trial. According to ICH E6, what is required during the consent process?
- A family member signs for the participant without discussion
- An impartial witness is present for the entire consent discussion (Correct answer)
- The participant cannot be enrolled under any circumstances
- Verbal agreement is recorded with no witness
Correct answer: An impartial witness is present for the entire consent discussion
An impartial witness attends the whole discussion and signs to confirm the information was explained and consent was freely given.
Question 3: Under 21 CFR 312.64, when must an investigator report a serious adverse event to the sponsor?
- Immediately (Correct answer)
- Within 30 days
- At the next monitoring visit
- In the annual progress report
Correct answer: Immediately
Investigators must report serious adverse events to the sponsor immediately, whether or not they think the event is drug-related.
Question 4: In a blinded trial, when may site staff break the blind for one participant?
- When the participant asks out of curiosity
- When a monitor asks during a routine visit
- In a medical emergency, following the protocol's unblinding procedure (Correct answer)
- At any time the coordinator considers it useful
Correct answer: In a medical emergency, following the protocol's unblinding procedure
Emergency unblinding follows protocol-defined procedures and is documented and reported to the sponsor.
Question 5: What is the main goal of the root cause analysis step in a CAPA plan?
- To identify the staff member to blame
- To find the underlying reason for a problem so the corrective action stops it from happening again (Correct answer)
- To close the issue as fast as possible
- To avoid reporting the issue to the sponsor
Correct answer: To find the underlying reason for a problem so the corrective action stops it from happening again
Effective CAPA targets the systemic cause rather than the symptom.
Question 6: How should a research assistant best prepare for a sponsor monitoring visit?
- Have source documents, the regulatory binder, and up-to-date CRFs ready for review (Correct answer)
- Take the binder offsite so it is not seen
- Back-date entries that were missing
- Cancel participant visits that day without notice
Correct answer: Have source documents, the regulatory binder, and up-to-date CRFs ready for review
Monitors verify CRF data against source and check regulatory files, so complete, accessible records make the visit efficient.
Question 7: Which statement about using a note-to-file (NTF) is considered best practice?
- NTFs can fix any missing documentation after the fact
- NTFs do not need a signature or date
- NTFs should replace reporting deviations to the IRB
- NTFs should explain a specific issue, be signed and dated, and not be used in place of corrective action (Correct answer)
Correct answer: NTFs should explain a specific issue, be signed and dated, and not be used in place of corrective action
Regulators warn against overusing NTFs; they record an explanation but do not correct systemic problems.
