Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
This guidance clarifies FDA's policy regarding data retention when subjects withdraw from FDA-regulated clinical trials. It applies to sponsors, clinical investigators, and IRBs, emphasizing that data collected up to the point of withdrawal must be maintained as part of the study database to ensure scientific validity and protect public health.
What You Need to Know? 👇
What happens to clinical trial data when a subject withdraws from an FDA-regulated study?
According to FDA policy, all data collected up to the point of withdrawal must remain in the trial database and cannot be removed. Withdrawal from a study does not extend to already-collected data, which remains part of the study records.
Can subjects request deletion of their data after withdrawing from a clinical trial?
No, subjects cannot request deletion of data already collected during their participation. FDA regulations require maintenance of all study data to ensure scientific validity and protect public health through complete safety and effectiveness evaluations.
What follow-up is allowed after a subject withdraws from the interventional portion of a study?
Investigators may ask withdrawing subjects if they consent to continued follow-up for clinical outcome information through non-invasive methods like chart review. This requires separate informed consent and IRB approval if not covered in original consent documents.
Why does FDA prohibit removal of withdrawn subjects’ data from clinical trials?
Data removal could compromise study validity through “informative censoring,” hide important safety information, distort effectiveness results, and prevent FDA from performing complete risk/benefit assessments necessary to protect public health and ensure product safety.
What records can investigators access after a subject withdraws and refuses continued follow-up?
Investigators can review previously collected study data and consult public records like survival status databases. However, they cannot access the subject’s medical records or other confidential information requiring consent for study purposes.
How do international guidelines support FDA’s data retention policy for withdrawn subjects?
International standards like ICH Good Clinical Practice and the Declaration of Helsinki emphasize that clinical trials must be scientifically sound. Removing data undermines scientific validity, making research unethical by exposing subjects to risks without potential benefit.
What You Need to Do 👇
Recommended Actions
- Implement procedures to maintain all data collected up to the point of subject withdrawal
- Develop a process for obtaining separate informed consent for continued follow-up after withdrawal
- Establish clear documentation procedures for subject withdrawal scenarios
- Create protocols for protecting subject privacy while maintaining required data
- Train staff on proper handling of withdrawn subject data and access restrictions
- Implement data management systems that prevent deletion of already collected data
- Develop procedures for consulting public records when needed after subject withdrawal
- Establish IRB review procedures for follow-up consent documents
- Create guidelines for distinguishing between study-related interventions and continued follow-up
- 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