The Impact of GCP R3 on Your Trial Master File

Clinical Trials

Introduction

The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was issued in January 2025. Though still pending adoption by individual member nations, the European Medicines Agency announced that the effective date for R3 would be 23 July 2025. The revision includes restructuring of the guideline and clarification of various aspects, which encourage fit-for-purpose, risk-based/proportionate approaches. One area impacted by the update is records which will impact your trial master file.

Glossary

The following relevant terms have been updated in R3. Additionally, clarification was added so that “investigational product” also can refer to a biological product, not just a pharmaceutical.

List of Records

The purpose of essential records is to aid in the management of the trial, collectively demonstrate the reliability of the results, and verify appropriate trial conduct. Previously, in R2, a table was provided listing what documents were needed for the site and sponsor at each phase of a trial. R3 takes a more general approach for determining what records are considered essential and denotes which ones should be in place before the start of the trial. Also, the records are described in a way that allows for flexibility of the media used and scalability based on the risk of the study. For example, the previous version called for “signed, dated, and completed case report forms (CRF)” whereas R3 lists “data and relevant metadata (including documentation of data corrections) in the data acquisition tools”. This allows that data may be collected and recorded by other means (e.g., direct electronic upload of wearable data). Similar updates have been made for other records to accept alternate records.

Availability of Records

Unchanged from R2, records must be available upon request for monitors, auditors, ethics committee or investigational review board, or regulatory authority. Since the investigator has the responsibility of trial participants’ safety, R3 adds a more explicit requirement for the provision of data by the sponsor to the investigator. This includes central laboratory data, electronic patient-reported outcomes, or other relevant external sources.

The record retention timeline specified in R2 was removed. Instead, R3 defers to applicable regulatory requirements for record retention periods. However, the sponsor should inform the site and service providers in writing of the record retention requirements.

Conclusion

The new ICH GCP R3 update offers risk-based and proportionate fit-for-purpose approaches for record keeping. Understanding what records are considered essential for a particular trial is important to demonstrate compliance with regulations and reduce the paperwork burden of the sponsor and the site so they can focus more on the patients.

Need help integrating GCP R3 for your study? MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion 855.463.1633 | askmed@medinstitute.com | medinstitute.com.