Question 10 of 20 Fundamentals Concept
What are essential records, and how long must they be kept?
Short answer
Essential records are the documents and data that let someone reconstruct how a trial was run and judge whether its results are reliable. The retention period comes from local law. EU sponsors and investigators must archive the trial master file for at least 25 years after the trial ends, while US IND rules set 2 years after approval or after the investigation stops.
Why
E6(R3) defines essential records as the documents, data and metadata, in any format, that allow evaluation of the methods used and verification that the trial followed GCP. Examples are the signed protocol and amendments, ethics approvals, signed consent forms, the delegation record, monitoring reports, safety reports and product accountability. Sponsor and site each keep their own file because their duties differ.
The EU Clinical Trials Regulation, Article 58, requires archiving for at least 25 years after the end of the trial, unless other EU law requires longer, with patients' medical files kept under national law. In the US, 21 CFR 312.62(c) requires investigators to keep records for 2 years after a marketing application is approved for the indication, or 2 years after the investigation is discontinued and FDA is notified. A global sponsor usually applies the longest period that could apply.
Records must stay readable for the whole period, which matters when a system is retired.
A strong answer covers
- Definition: records that allow trial conduct and data reliability to be evaluated
- Concrete examples across consent, safety, delegation and monitoring
- EU at least 25 years under CTR Article 58
- US 2 years after approval or discontinuation under 21 CFR 312.62(c)
- Readability and access across system changes
Common mistakes
- Quoting a single worldwide retention period.
- Assuming electronic records are retained simply because the system still exists.
- Thinking only the sponsor needs a trial master file.
The interviewer might ask next
What would you check before a site retires the electronic system that holds its source records?