CCRC Protocol Deviations & Amendments 2 — Questions and Answers
Question 1: Which document is primarily used at a clinical research site to track and manage protocol deviations?
- Case Report Form (CRF)
- Protocol Deviation Log (Correct answer)
- Investigator's Brochure
- Site Master File
Correct answer: Protocol Deviation Log
A Protocol Deviation Log is maintained at the site to systematically track, categorize, and manage all deviations from the approved protocol.
Question 2: A study participant completed a required blood draw 5 days outside the protocol-specified visit window. This is an example of:
- A serious adverse event
- A protocol deviation (Correct answer)
- An unanticipated problem requiring immediate IRB reporting
- A regulatory violation requiring FDA notification
Correct answer: A protocol deviation
Missing a required assessment window is a common type of protocol deviation that must be documented in the site's deviation log.
Question 3: A protocol deviation rises to the level of a protocol violation when it:
- Involves the investigational product in any way
- Is reported to the sponsor after the study closes
- Affects participant safety, rights, or data integrity (Correct answer)
- Occurs more than once at the same site
Correct answer: Affects participant safety, rights, or data integrity
Deviations rise to the level of violations when they compromise participant safety, rights, welfare, or the integrity of collected data.
Question 4: Which of the following is an example of a MAJOR protocol deviation?
- A minor typographical error in a study log entry
- Enrollment of a participant who did not meet all inclusion criteria (Correct answer)
- A study visit conducted one day outside the allowed window with no data impact
- A participant completing a questionnaire in a different room than specified
Correct answer: Enrollment of a participant who did not meet all inclusion criteria
Enrolling a participant who does not meet eligibility criteria is a major deviation because it may affect data integrity and participant safety.
Question 5: Under FDA regulations (21 CFR 312.62), how long must clinical trial records generally be retained after the study is completed?
- 2 years from study completion
- 5 years from study completion
- At least 2 years after the investigational product's marketing application is approved or investigations discontinued (Correct answer)
- Until the principal investigator retires from practice
Correct answer: At least 2 years after the investigational product's marketing application is approved or investigations discontinued
FDA regulations require that records be retained for at least 2 years after a marketing application is approved or clinical investigations are discontinued.
Question 6: Which regulatory body must IND sponsors notify when serious or unexpected protocol deviations occur in the United States?
- NIH (National Institutes of Health)
- ICH (International Council for Harmonisation)
- FDA (Food and Drug Administration) (Correct answer)
- WHO (World Health Organization)
Correct answer: FDA (Food and Drug Administration)
Under 21 CFR Part 312, IND sponsors must report significant protocol deviations and safety issues to the FDA.
Question 7: A CRC discovers that a protocol deviation occurred 2 weeks ago but was never documented. The BEST course of action is to:
- Ignore it since sufficient time has passed and it may not be found
- Document the deviation now with a note explaining the delay and notify the PI (Correct answer)
- Destroy any evidence to prevent an audit finding
- Terminate the affected participant immediately from the study
Correct answer: Document the deviation now with a note explaining the delay and notify the PI
Late documentation is always better than no documentation; the CRC should document the deviation with an explanation of the delay and escalate appropriately to the PI.
CCRC Protocol Deviations & Amendments 2
Which document is primarily used at a clinical research site to track and manage protocol deviations?