Communication and Documentation Flashcards

Which FDA regulation sets requirements for electronic records and electronic signatures in clinical research?

Answer: 21 CFR Part 11

21 CFR Part 11 covers trustworthy electronic records, audit trails, and electronic signatures.

A coworker asks to borrow your EDC login to finish data entry. What is the correct response?

Answer: Decline, because credentials are unique to each user and sharing them breaks attribution

Shared credentials make audit trails meaningless and violate Part 11 attribution requirements.

Under HIPAA, which approach best limits disclosure of protected health information to a sponsor?

Answer: Apply the minimum necessary standard and use coded study IDs

HIPAA's minimum necessary principle and coded identifiers protect participant privacy.

Under the FDAAA requirement, how soon after enrolling the first participant must an applicable clinical trial be registered on ClinicalTrials.gov?

Answer: Within 21 days

FDAAA 801 requires registration no later than 21 days after the first participant is enrolled.

Which documents typically belong in the investigator site file (regulatory binder)?

Answer: Signed Form FDA 1572, IRB approvals, CVs, licenses, and lab certifications

Essential documents in ICH E6 include investigator agreements, IRB correspondence, staff qualifications, and lab certifications.

A participant stops attending visits. Before recording them as lost to follow-up, what should the site do?

Answer: Make and document several contact attempts, such as phone calls and a certified letter

Documented, repeated contact attempts are needed before declaring a participant lost to follow-up.

After a monitoring visit, the monitor sends a follow-up letter listing action items. What should the site do?

Answer: Address each item, document the resolution, and file the letter in the regulatory binder

Monitoring correspondence and its resolutions are essential documents that show oversight and corrective action.