Continuing Education Requirements Flashcards

After a serious protocol deviation caused by a staff knowledge gap, what training response is most appropriate?

Answer: Targeted retraining documented as part of the corrective and preventive action (CAPA)

Documented targeted retraining is a standard CAPA step for deviations caused by gaps in knowledge.

A research assistant moves from a drug study to a medical device study. What extra training is most relevant?

Answer: FDA device regulations such as 21 CFR Part 812 (IDE)

Device studies fall under 21 CFR Part 812, so training on IDE requirements is directly relevant.

Which of these is generally accepted as CE for research professionals?

Answer: Publishing a peer-reviewed article on clinical research methods

Many certifying bodies give CE credit for professional contributions such as publishing in peer-reviewed journals.

Which training topic is most directly linked to the informed consent process?

Answer: 45 CFR 46 and 21 CFR 50 requirements

Informed consent requirements are set out in 45 CFR 46 (Common Rule) and 21 CFR 50 (FDA).

What does an institution typically do when an investigator's or staff member's required human subjects training has expired?

Answer: Stops them from doing study activities until training is current

Institutions usually stop staff with expired required training from study activities until they complete a refresher.

Which training should research staff complete before handling electronic records and signatures in FDA-regulated trials?

Answer: 21 CFR Part 11 training

21 CFR Part 11 governs electronic records and signatures, so staff using these systems should be trained on it.

What is the main reason CE activities should come from accredited or recognized providers?

Answer: Accreditation helps ensure content quality and acceptance by certifying bodies

Certifying bodies more readily accept courses from accredited providers because accreditation shows quality standards were met.