What Must Be Retained for 25 Years – Regulation 31A

What it is: The trial records kept at each study site (hospital or clinic).

What to keep:

• Site-level essential documents
• Communication with the sponsor
• Site training records
• Local approvals

Why it matters: Shows that each site followed the protocol and protected participants. Records must protect patient privacy but still be available to regulators.

What it is: These are the main documents that explain how the trial worked.

Examples include:

• The study protocol and any updates
• Investigator’s Brochure versions
• Ethics and regulatory approvals
• Contracts and agreements
• Monitoring visit reports
• Audit reports
• Delegation of authority logs
• Staff training records
• Safety management documents
• Data management plans

Why it matters: These prove the trial was properly designed, approved, supervised, and controlled.

What this includes:

• Signed informed consent forms
• Subject ID code lists (if allowed by data protection laws)
• Source data agreements
• Documents showing consent, enrolment, and identity checks

Why it matters: These prove that participants agreed to join the study and were handled correctly and legally.

What this includes:

• Paper or electronic Case Report Forms (CRFs/eCRFs)
• Clinical datasets
• Statistical analysis results
• Randomisation records
• IRT (Interactive Response Technology) records
• Safety databases
• Coding dictionaries (e.g., for medical terms)
• Output tables and listings used in analysis

Why it matters: You must be able to recreate the study results and confirm that the conclusions were correct.

What this means: Background system information that proves data is real and unchanged.

Examples:

• System logs showing who made changes and when
• Version histories
• Electronic signatures
• Records showing where data came from
• Integrity or checksum records

Why it matters: These prove the data is trustworthy and has not been altered. It also emphasises the need for a fit for purpose archiving system.