Duration of FDA-mandated Storage for Trial-Related Records- Understanding the FDA’s Record Retention Requirements

How Long Does the FDA Require Storage of Trial-Related Records?

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs and medical devices. One of the key aspects of the FDA’s regulatory process involves the thorough review of trial-related records. These records provide essential information about the conduct of clinical trials, the safety and efficacy of the investigational product, and the data supporting approval. However, it is important to understand how long the FDA requires the storage of these records. In this article, we will explore the duration for which the FDA mandates the retention of trial-related records and the implications of non-compliance.

Importance of Trial-Related Records

Trial-related records are vital for the FDA’s assessment of the quality and integrity of clinical trials. These records include documentation of the study design, participant consent, data collection, and analysis. By reviewing these records, the FDA can ensure that the trials were conducted ethically and in accordance with regulatory guidelines. Additionally, these records serve as a reference for post-marketing surveillance, allowing the agency to monitor the safety and effectiveness of approved products over time.

Duration of Record Storage

The FDA requires the storage of trial-related records for a specific duration, which varies depending on the type of record and the nature of the trial. Generally, the FDA mandates the retention of records for at least 2 years after the last subject has completed the study. However, in certain cases, the duration may be extended.

For instance, if the trial involves an investigational new drug (IND) or an investigational device exemption (IDE), the FDA requires the retention of records for at least 2 years after the trial is terminated or the IND/IDE is withdrawn. Additionally, if the trial is part of a New Drug Application (NDA) or a Biologics License Application (BLA), the FDA may require the retention of records for up to 30 years after the approval of the drug or biologic.

Records to Be Retained

The FDA specifies the types of records that must be retained during the required storage period. These records include, but are not limited to:

1. Study protocols and amendments
2. Informed consent forms and documentation
3. Case report forms (CRFs) and associated data
4. Laboratory and other test results
5. Adverse event reports
6. Statistical analyses and reports
7. Correspondence with the FDA

Consequences of Non-Compliance

Failure to comply with the FDA’s record retention requirements can have serious consequences. Non-compliance may result in warnings, fines, or even the suspension or withdrawal of approval for the investigational product. Moreover, it can lead to legal action, including civil penalties and criminal charges.

Conclusion

Understanding the FDA’s requirements for the storage of trial-related records is crucial for pharmaceutical and biotechnology companies. By adhering to the agency’s guidelines, companies can ensure the integrity of their clinical trials and maintain compliance with regulatory standards. The retention of these records for the specified duration is essential for the FDA’s ongoing oversight and monitoring of the safety and efficacy of approved products.