Safety and Compliance Flashcards

For an FDA-regulated drug study, how long must investigators retain study records if the drug is approved for the studied indication?

Answer: 2 years after the marketing application is approved

21 CFR 312.62(c) requires retention for 2 years after approval, or 2 years after the investigation is discontinued and FDA notified.

A non-English-speaking participant is enrolled using an IRB-approved short-form consent. Who must be present during the oral presentation?

Answer: A witness who signs both the short form and the summary

The short-form method requires a witness to the oral presentation who signs the short form and a copy of the summary.

Which document does an investigator sign to commit to FDA requirements when participating in a drug or biologic IND study?

Answer: Form FDA 1572

Form FDA 1572, the Statement of Investigator, lists sites, sub-investigators, and the investigator's commitments.

What does a Certificate of Confidentiality primarily protect against?

Answer: Compelled disclosure of identifiable research information in legal proceedings

Certificates of Confidentiality protect identifiable sensitive research data from forced disclosure, such as subpoenas.

When working with liquid nitrogen in a small storage room, which hazard is often overlooked in addition to cold burns?

Answer: Oxygen-deficient atmosphere causing asphyxiation

Evaporating nitrogen displaces oxygen, so poorly ventilated rooms need oxygen monitors.

New information arises mid-study that could affect participants' willingness to continue. What is generally required?

Answer: Inform participants and obtain re-consent with an IRB-approved revised form

Significant new findings must be shared, typically through IRB-approved re-consent.

Which federal subpart of 45 CFR 46 provides additional protections specifically for prisoners in research?

Answer: Subpart C

Subpart C covers prisoners, while B covers pregnant women and fetuses and D covers children.