Ethical Standards & Compliance Flashcards

Under 21 CFR 312.32, a sponsor must report an unexpected fatal or life-threatening suspected adverse reaction to FDA no later than:

Answer: 7 calendar days

Unexpected fatal or life-threatening suspected adverse reactions require IND safety reporting within 7 calendar days.

Other serious and unexpected suspected adverse reactions (not fatal or life-threatening) must be reported by the sponsor to FDA within:

Answer: 15 calendar days

21 CFR 312.32 requires IND safety reports within 15 calendar days for serious, unexpected suspected adverse reactions.

Which adverse event outcome automatically qualifies an event as 'serious'?

Answer: Inpatient hospitalization or prolongation of existing hospitalization

Hospitalization is one of the regulatory criteria for a serious adverse event, along with death, life-threatening events, and persistent disability.

Per OHRP guidance, an 'unanticipated problem involving risks to subjects or others' must be:

Answer: Unexpected, related or possibly related to the research, and suggesting greater risk of harm

OHRP defines unanticipated problems by three criteria: unexpected, related or possibly related, and indicating increased risk.

Under 21 CFR 312.64(b), when must an investigator report a serious adverse event to the sponsor?

Answer: Immediately

Investigators must immediately report any serious adverse event to the sponsor, whether or not considered drug related.

21 CFR Part 11 establishes FDA requirements for:

Answer: Electronic records and electronic signatures

Part 11 sets criteria for trustworthy electronic records and signatures equivalent to paper records.

What is Form FDA 1572 used for in drug trials?

Answer: The investigator's commitment to conduct the study per IND regulations (Statement of Investigator)

Form FDA 1572 is the Statement of Investigator listing sub-investigators, sites, and IRB, and the investigator's commitments.