SOCRA Knowledge 5 — Questions and Answers
Question 1: Under 21 CFR 812.150, an investigator must report an unanticipated adverse device effect to the sponsor and IRB within:
- 5 working days
- 10 working days (Correct answer)
- 15 calendar days
- 30 calendar days
Correct answer: 10 working days
Investigators must submit UADE reports to the sponsor and reviewing IRB as soon as possible but no later than 10 working days.
Question 2: When the short form written consent method is used under 21 CFR 50.27(b)(2), who must sign the written summary?
- Only the subject
- Only the principal investigator
- The subject and the IRB chair
- The witness and the person obtaining consent (Correct answer)
Correct answer: The witness and the person obtaining consent
The witness signs both the short form and the summary, and the person obtaining consent signs the summary.
Question 3: In pediatric research under 21 CFR Part 50 Subpart D, a child's affirmative agreement to participate is called:
- Assent (Correct answer)
- Permission
- Consent
- Authorization
Correct answer: Assent
Assent is the child's affirmative agreement, while parents or guardians provide permission.
Question 4: Which requirement is unique to the exception from informed consent for emergency research under 21 CFR 50.24?
- Use of a short form consent
- Approval by two separate IRBs
- Community consultation and public disclosure (Correct answer)
- Waiver of all IRB continuing review
Correct answer: Community consultation and public disclosure
Emergency research without consent requires consultation with the communities involved and public disclosure before and after the study.
Question 5: Under FDAAA Section 801, an applicable clinical trial must be registered on ClinicalTrials.gov no later than:
- Before IRB submission
- 21 days after enrolling the first participant (Correct answer)
- 90 days after study completion
- 1 year after primary completion
Correct answer: 21 days after enrolling the first participant
FDAAA 801 requires registration within 21 days after enrollment of the first participant.
Question 6: Under 21 CFR 312.30, a protocol change intended to eliminate an apparent immediate hazard to subjects may be implemented:
- Only after FDA approves the amendment
- Only after full-board IRB approval
- After a 30-day FDA waiting period
- Immediately, with subsequent notification to FDA and the IRB (Correct answer)
Correct answer: Immediately, with subsequent notification to FDA and the IRB
Changes to eliminate immediate hazards can be made at once, provided FDA and the IRB are notified afterward.
Question 7: In the ALCOA data quality principles, what does the letter "C" stand for?
- Complete
- Consistent
- Contemporaneous (Correct answer)
- Confidential
Correct answer: Contemporaneous
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
