Document Management and Retention

Question 1

Per 45 CFR 46.115(b) and 21 CFR 56.115(b), institutions and IRBs must retain what types of records? (There’s 6 here but if you name a few, call it a win)

Answer 1

IRB records;
Research protocols and materials;
Informed consent forms;
Correspondence related to the study;
IRB review documentation;
Reports of unanticipated problems or noncompliance.

Question 2

How Long Must Records Be Retained?

Answer 2

At least 3 years after completion of the research or IRB approval termination.

For FDA-regulated research related to product approval, longer retention may be required by the sponsor or FDA

Question 3

Records may be paper or electronic, but must be what four things?

Answer 3

1. Complete
2. Legible
3. Secure
4. Accessible for inspection by OHRP, FDA, or other oversight agencies

Question 4

Electronic systems must be what two things in addition to the standard requirements?

Answer 4

Validated for integrity

Auditable (e.g., version history, timestamps)

Question 5

True or False: Institutions don’t need to make records available upon request after 3 years have passed since study closure.

Answer 5

False. They need to make records available even years after the study ends.

Question 6

For FDA Regulated Research, how long do investigators need to retain study records?

Answer 6

At least 2 years after the IND is withdrawn, or the FDA approves or discontinues the marketing application. Sponsors may impose longer durations.

Question 7

Who can inspect IRB and research records?

Answer 7

Oversight agencies like OHRP and FDA.