CPI Emergency Procedures & Response 3 — Questions and Answers
Question 1: A clinical trial participant becomes incapacitated mid-study and can no longer provide ongoing consent. The investigator should:
- Continue study procedures as originally consented
- Obtain consent from a legally authorized representative and reassess continued participation (Correct answer)
- Discontinue all study procedures immediately without LAR consultation
- Consult the IRB before taking any action
Correct answer: Obtain consent from a legally authorized representative and reassess continued participation
When a participant loses capacity, a legally authorized representative must be engaged to provide proxy consent before study procedures continue.
Question 2: An investigator discovers a protocol deviation occurred during an emergency—study drug was given outside the dosing window to stabilize a participant. This should be:
- Not reported because the deviation was medically justified
- Documented and reported to the IRB and sponsor per protocol deviation procedures (Correct answer)
- Reported only to the sponsor, not the IRB
- Corrected by adjusting the next scheduled dose without documentation
Correct answer: Documented and reported to the IRB and sponsor per protocol deviation procedures
All protocol deviations, including those made for emergency medical reasons, must be documented and reported to both the IRB and sponsor.
Question 3: Which regulatory pathway allows emergency use of an unapproved drug outside of a clinical trial when no alternatives exist?
- Expanded access (compassionate use) under 21 CFR 312.310 (Correct answer)
- Emergency IND waiver under 21 CFR 312.44
- Institutional emergency authorization under IRB guidelines
- FDA Emergency Use Authorization under 21 CFR 601
Correct answer: Expanded access (compassionate use) under 21 CFR 312.310
21 CFR 312.310 governs individual patient expanded access (compassionate use) for emergency situations where no alternatives are available.
Question 4: A study participant is hospitalized for an SAE. The investigator's source document responsibilities include:
- Only the sponsor's case report form (CRF) entries
- Hospital records, lab results, and a narrative linking the event to study participation (Correct answer)
- A brief notation in the research file that hospitalization occurred
- Documents only if the event is deemed possibly related to study drug
Correct answer: Hospital records, lab results, and a narrative linking the event to study participation
Complete source documentation for SAEs includes all medical records, lab data, and a narrative account regardless of causality assessment.
Question 5: During a clinical trial, a participant suffers a stroke. The investigator assesses causality as 'unlikely related' to study drug. This assessment:
- Eliminates the need to report the event to the sponsor
- Does not affect the reporting obligation; all SAEs must be reported to the sponsor (Correct answer)
- Allows a 30-day extended reporting window instead of 7 days
- Requires IRB review before the sponsor is notified
Correct answer: Does not affect the reporting obligation; all SAEs must be reported to the sponsor
All serious adverse events must be reported to the sponsor regardless of the investigator's causality assessment; the sponsor then makes relatedness determinations for FDA reporting.
Question 6: An emergency protocol amendment is submitted to the IRB to allow a new rescue medication. Under which condition may the investigator implement the amendment before IRB approval?
- Never; all amendments require prior IRB approval
- When immediate use is necessary to eliminate apparent immediate hazard to participants (Correct answer)
- When the sponsor provides written authorization
- When the amendment involves only minor procedural changes
Correct answer: When immediate use is necessary to eliminate apparent immediate hazard to participants
Under 21 CFR 56.108(a)(4), investigators may implement unapproved changes when necessary to eliminate an apparent immediate hazard, followed by prompt IRB notification.
Question 7: A clinical site's emergency contact list for participants should include all of the following EXCEPT:
- 24-hour investigator or on-call physician contact
- Local emergency services (911)
- Sponsor's medical monitor emergency line
- Participant's personal financial advisor (Correct answer)
Correct answer: Participant's personal financial advisor
Emergency contact materials for participants include medical contacts (investigator, sponsor medical monitor, emergency services) but not personal financial advisors.
CPI Emergency Procedures & Response 3
A clinical trial participant becomes incapacitated mid-study and can no longer provide ongoing consent.
The investigator should: