SOCRA Basic 4 — Questions and Answers
Question 1: Under 21 CFR 312.64, when must an investigator report a serious adverse event to the sponsor?
- Immediately, whether or not it is considered drug related (Correct answer)
- Within 15 calendar days of learning of the event
- Only if the investigator judges it to be drug related
- At the next scheduled monitoring visit
Correct answer: Immediately, whether or not it is considered drug related
21 CFR 312.64(b) requires investigators to report any serious adverse event to the sponsor immediately, regardless of suspected causality.
Question 2: Under 21 CFR 56.107, what is the minimum number of members an IRB must have?
- Three
- Five (Correct answer)
- Seven
- Nine
Correct answer: Five
FDA regulations require each IRB to have at least five members with varying backgrounds.
Question 3: What is the purpose of Form FDA 1572?
- Financial disclosure by clinical investigators
- Statement of Investigator committing to comply with IND regulations (Correct answer)
- Sponsor's annual IND progress report
- IRB registration with FDA
Correct answer: Statement of Investigator committing to comply with IND regulations
Form FDA 1572 is the Statement of Investigator, in which the investigator agrees to conduct the study under 21 CFR 312 requirements.
Question 4: Under 21 CFR 312.62(c), if a marketing application is approved, how long must an investigator retain study records?
- 1 year after study completion
- 2 years after the marketing application is approved for the indication (Correct answer)
- 5 years after the last subject's final visit
- 15 years after study start
Correct answer: 2 years after the marketing application is approved for the indication
Investigators must retain records for 2 years after approval, or 2 years after the investigation is discontinued and FDA is notified if no application is filed or approved.
Question 5: Which Belmont Report principle most directly requires fair and equitable selection of research subjects?
- Respect for persons
- Beneficence
- Justice (Correct answer)
- Autonomy
Correct answer: Justice
The principle of justice concerns the fair distribution of research burdens and benefits, which is applied through equitable subject selection.
Question 6: Under 21 CFR 56.110, who may carry out an expedited IRB review?
- The study sponsor's medical monitor
- The IRB chairperson or one or more experienced reviewers designated by the chair (Correct answer)
- Any IRB administrative staff member
- The principal investigator together with the study coordinator
Correct answer: The IRB chairperson or one or more experienced reviewers designated by the chair
Expedited review may be done by the IRB chair or by experienced IRB members the chair designates, but they cannot disapprove the research.
Question 7: How quickly must a sponsor report an unexpected fatal or life-threatening suspected adverse reaction to FDA in an IND safety report?
- Within 24 hours
- Within 7 calendar days (Correct answer)
- Within 15 calendar days
- In the annual report
Correct answer: Within 7 calendar days
21 CFR 312.32(c)(2) requires notification no later than 7 calendar days after the sponsor first receives the information.
