Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies

Recommended Actions

1. Implement procedures to maintain all data collected up to the point of subject withdrawal
2. Develop a process for obtaining separate informed consent for continued follow-up after withdrawal
3. Establish clear documentation procedures for subject withdrawal scenarios
4. Create protocols for protecting subject privacy while maintaining required data
5. Train staff on proper handling of withdrawn subject data and access restrictions
6. Implement data management systems that prevent deletion of already collected data
7. Develop procedures for consulting public records when needed after subject withdrawal
8. Establish IRB review procedures for follow-up consent documents
9. Create guidelines for distinguishing between study-related interventions and continued follow-up
10. Document compliance with data retention requirements in standard operating procedures

Key Considerations

Clinical testing

• Already-accrued data must be maintained when subjects withdraw from a study
• Complete removal of data would compromise study validity
• Intent-to-treat analyses are required
• Follow-up data collection after withdrawal requires separate informed consent
• Access to medical records after withdrawal requires subject consent

Safety

• All safety data must be maintained to ensure proper risk/benefit assessment
• Removal of data could hide important safety information
• Data maintenance is crucial for protecting enrolled subjects, future subjects, and eventual users

Other considerations

• Privacy and confidentiality of subject information must be safeguarded
• Public records may be consulted even after subject withdrawal
• IRB approval is required for informed consent documents for continued follow-up
• Scientific validity is essential for ethical research

  Relevant Guidances

• Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
• Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
• Use of Electronic Informed Consent in Clinical Investigations
• Design Controls for Medical Device Manufacturers
• Electronic Records and Electronic Signatures - Scope and Application

Related references and norms

• ICH E6: Good Clinical Practice: Consolidated Guidance
• 21 CFR Part 312: Investigational New Drug Application
• 21 CFR Part 812: Investigational Device Exemptions

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Original guidance

• Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
• HTML / PDF
• Issue date: 2008-10-01
• Last changed date: 2021-07-21
• Status: FINAL
• Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
• ReguVirta summary file ID: 40019042c651a843f701af246d7d6bee