SOCRA Knowledge 5

Question 1

Under 21 CFR 812.150, an investigator must report an unanticipated adverse device effect to the sponsor and IRB within:

Accepted Answer

10 working days

Answer

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?

Accepted Answer

The witness and the person obtaining consent

Answer

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:

Accepted Answer

Assent

Answer

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?

Accepted Answer

Community consultation and public disclosure

Answer

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:

Accepted Answer

21 days after enrolling the first participant

Answer

FDAAA 801 requires registration within 21 days after enrollment of the first participant.

(SOCRA) Society of Clinical Research Associates Practice Test