UK MHRA Guidance: Archiving and Retention of Clinical Trial Records

This guidance, "Archiving and retention of clinical trial records," explains the requirements for archiving and retaining clinical trial records. Proper archiving is essential to ensure that trial data remains accessible, accurate, and verifiable over time. It supports regulatory compliance and ensures that clinical trials can be reviewed, inspected, or audited when required.

Purpose of Archiving and Retention

The purpose of this guidance is to ensure that essential clinical trial documents are retained securely and remain available for future reference.

This helps to:

• Maintain data integrity and traceability

• Support regulatory inspections and audits

• Protect participant safety and rights

• Ensure long-term accessibility of trial information

Scope and Applicability

This guidance applies to all stakeholders involved in clinical trials, including sponsors, investigators, and trial sites. It covers both paper and electronic records, ensuring that all formats are managed appropriately throughout the retention period.

What Should Be Archived

According to this guidance, essential documents must be archived to allow reconstruction of the trial.

These include:

• Trial protocols and amendments

• Investigator’s Brochure

• Case report forms (CRFs)

• Informed consent forms

• Regulatory approvals and correspondence

• Safety reports and adverse event records

These documents are critical for verifying compliance with Good Clinical Practice (GCP).

Retention Period

This guidance specifies that clinical trial records must be retained for defined periods, depending on regulatory requirements.

Retention timelines are designed to ensure that:

• Data remains available for regulatory review

• Long-term safety and efficacy can be assessed

• Legal and compliance obligations are met

Sponsors are typically responsible for defining and ensuring adherence to retention timelines.

Archiving Requirements

As outlined in this guidance, archived records must be stored securely and in a manner that preserves their integrity.

Key requirements include:

• Protection from damage, loss, or unauthorised access

• Controlled storage environments

• Clear indexing and retrieval systems

• Maintenance of readability and completeness

Both physical and electronic records must remain accessible throughout the retention period.

Responsibilities of Stakeholders

This guidance clearly defines stakeholder responsibilities in archiving and retention.

Responsibilities include:

• Sponsors ensuring proper archiving systems are in place

• Investigators maintaining site-level records

• Ensuring records are complete, accurate, and up to date

• Facilitating access during inspections or audits

Failure to meet these responsibilities may lead to compliance issues.

Inspection and Accessibility

Under this guidance, archived records must be readily accessible for regulatory inspections.

Regulators may:

• Request access to archived documents

• Verify data integrity and compliance

• Assess adherence to Good Clinical Practice (GCP)

Proper archiving ensures that records can be retrieved without delay.

Importance of Proper Archiving

As emphasised in this guidance, effective archiving is critical to maintaining the credibility of clinical trials.

It ensures:

• Long-term data reliability

• Transparency in clinical research

• Compliance with regulatory requirements

• Continued protection of participant information

📌 Reference

For full details, refer to the official guidance "Archiving and retention of clinical trial records".