Knowledge Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Knowledge flashcards as text
Under 21 CFR 812.150, an investigator must report an unanticipated adverse device effect to the sponsor and IRB within:
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.
When the short form written consent method is used under 21 CFR 50.27(b)(2), who must sign the written summary?
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.
In pediatric research under 21 CFR Part 50 Subpart D, a child's affirmative agreement to participate is called:
Answer: Assent
Assent is the child's affirmative agreement, while parents or guardians provide permission.
Which requirement is unique to the exception from informed consent for emergency research under 21 CFR 50.24?
Answer: Community consultation and public disclosure
Emergency research without consent requires consultation with the communities involved and public disclosure before and after the study.
Under FDAAA Section 801, an applicable clinical trial must be registered on ClinicalTrials.gov no later than:
Answer: 21 days after enrolling the first participant
FDAAA 801 requires registration within 21 days after enrollment of the first participant.
Under 21 CFR 312.30, a protocol change intended to eliminate an apparent immediate hazard to subjects may be implemented:
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.
In the ALCOA data quality principles, what does the letter "C" stand for?
Answer: Contemporaneous
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.