Industry Best Practices Flashcards

Under 21 CFR Part 11, what must an electronic records system audit trail record?

Answer: A secure, computer-generated, time-stamped record of entries and changes, including who made them

Part 11 requires secure, computer-generated, time-stamped audit trails that do not hide previously recorded information.

Two coordinators share one EDC login so they can work faster. Why is this unacceptable?

Answer: It makes entries impossible to attribute to a specific person

Unique user credentials are needed so every entry can be attributed, which is a core ALCOA and Part 11 principle.

According to ICH E6, what is a certified copy?

Answer: A copy verified as having the same information, including context and metadata, as the original

A certified copy has been verified, by dated signature or a validated process, to hold the same information as the original.

Which participant payment approach is considered best practice by IRBs?

Answer: Prorated payments for each completed visit, at a level that is not coercive

Prorating payment and avoiding excessive amounts reduces undue influence and protects the right to withdraw.

Which FDA regulation requires disclosure of clinical investigators' financial interests in covered clinical studies?

Answer: 21 CFR Part 54

21 CFR Part 54 covers financial disclosure, using Forms FDA 3454 and 3455.

What is the best practice for documenting concomitant medications during a trial?

Answer: Record all medications, including OTC drugs and supplements, with dose and start and stop dates, at each visit

Complete concomitant medication records support eligibility, interaction, and safety assessments.

When enrolling a 10-year-old in a minimal-risk study, what is generally required under 45 CFR 46 Subpart D?

Answer: Permission from a parent or guardian plus the child's assent when appropriate

Research with children requires parental permission and, when the child can give it, the child's assent.