Communication and Documentation Flashcards

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

Answer: Immediately

FDA regulations require investigators to report serious adverse events to the sponsor immediately.

A sponsor learns of a fatal, unexpected suspected adverse reaction in an IND study. What is the deadline for notifying FDA?

Answer: No later than 7 calendar days

Unexpected fatal or life-threatening suspected adverse reactions must be reported to FDA within 7 calendar days.

How do 'severity' and 'seriousness' differ when documenting an adverse event?

Answer: Severity describes intensity, while seriousness depends on outcome criteria such as hospitalization or death

A severe headache is not necessarily serious; seriousness is defined by regulatory outcome criteria.

Which standardized dictionary is commonly used to code adverse event terms in clinical trial databases?

Answer: MedDRA

MedDRA is the international medical terminology used to code adverse events for regulatory reporting.

A site enrolls a participant who does not meet an eligibility criterion. How should this be documented?

Answer: Record it as a protocol deviation and report it to the sponsor and IRB according to their requirements

Eligibility violations are protocol deviations that must be documented and reported according to sponsor and IRB policies.

What is a 'note to file' typically used for in a regulatory binder?

Answer: To explain a discrepancy, missing document, or site process that cannot be shown elsewhere

A note to file explains an issue or decision and should be signed, dated, and used sparingly.

Which details should an adverse event record include?

Answer: Onset and end dates, severity, seriousness, relationship to study product, action taken, and outcome

Complete AE documentation captures timing, intensity, causality, actions taken, and outcome.