SOCRA Adverse Event Safety Reporting 2 — Questions and Answers
Question 1: According to FDA regulations (21 CFR 312.32), which of the following outcomes makes an adverse event classified as 'serious'?
- Causes mild nausea lasting more than 24 hours
- Results in persistent or significant disability or incapacity (Correct answer)
- Requires an unscheduled outpatient clinic visit
- Causes temporary fatigue or lethargy
Correct answer: Results in persistent or significant disability or incapacity
An SAE is one that results in death, is life-threatening, requires inpatient hospitalization, causes persistent or significant disability, is a congenital anomaly, or is medically significant.
Question 2: An investigator must report a serious adverse event (SAE) to the sponsor within what timeframe per ICH E6 GCP guidelines?
- Immediately upon occurrence
- Within 24 hours of awareness (Correct answer)
- Within 7 calendar days of awareness
- Within 15 calendar days of occurrence
Correct answer: Within 24 hours of awareness
ICH E6 requires investigators to report SAEs to the sponsor promptly, typically within 24 hours of first awareness of the event.
Question 3: Which FDA form is used by sponsors to submit expedited IND safety reports (individual case safety reports) to the agency?
- FDA Form 1572 (Statement of Investigator)
- FDA Form 3500A (MedWatch) (Correct answer)
- FDA Form 356h (NDA Application)
- FDA Form 2253 (Promotional Materials)
Correct answer: FDA Form 3500A (MedWatch)
FDA Form 3500A (MedWatch) is the mandatory reporting form used for expedited IND safety reports submitted to the FDA.
Question 4: In the context of adverse event reporting, an event is considered 'unexpected' when:
- It occurs in less than 1% of clinical trial subjects
- Its nature, severity, or frequency is not consistent with the Investigator's Brochure (Correct answer)
- It has never been described in the published scientific literature
- It occurs without a clear temporal relationship to drug administration
Correct answer: Its nature, severity, or frequency is not consistent with the Investigator's Brochure
An unexpected adverse reaction is one whose nature, severity, specificity, or outcome is not consistent with what is described in the current Investigator's Brochure (IB).
Question 5: A sponsor must report a fatal or life-threatening unexpected suspected adverse reaction (SUSAR) to the FDA within:
- 7 calendar days (Correct answer)
- 15 calendar days
- 24 hours
- 30 calendar days
Correct answer: 7 calendar days
Fatal or life-threatening SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial awareness under 21 CFR 312.32(c)(2).
Question 6: Which element is required to classify an adverse event as a 'suspected adverse reaction' rather than a general AE?
- The event results in hospitalization
- There is a reasonable possibility that the investigational drug caused the event (Correct answer)
- The event is observed in more than one subject
- The event is listed in the protocol as a safety endpoint
Correct answer: There is a reasonable possibility that the investigational drug caused the event
A suspected adverse reaction requires a reasonable possibility of a causal relationship between the investigational drug and the adverse event, as assessed by the investigator or sponsor.
Question 7: Under 21 CFR 312.32, non-fatal, non-life-threatening unexpected SUSARs must be reported to the FDA within:
- 7 calendar days
- 15 calendar days (Correct answer)
- 30 calendar days
- 60 calendar days
Correct answer: 15 calendar days
Non-fatal, non-life-threatening unexpected SUSARs must be reported to the FDA within 15 calendar days of the sponsor's first awareness.
SOCRA Adverse Event Safety Reporting 2
According to FDA regulations (21 CFR 312.32), which of the following outcomes makes an adverse event classified as 'serious'?