The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.

Discussion points include:

• The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.

• The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.

• Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.

• Considerations for companies that outsource TMF management to CROs.

• The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.

• The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).

• How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.

Donna's top 5 takeaways:

1. Adopt the TMF Reference Model to standardize the structuring of TMFs across organizations. This makes integrating content from different vendors easier and simplifies regulatory inspections by providing a uniform structure that regulators have come to expect.


2. Focus on the record quality, timeliness, and completeness of the TMF. High-quality records without missing or draft pages, timely filing of documents to reflect an up-to-date story of the study, and ensuring that the TMF is complete with all necessary documents are crucial for a compliant TMF.


3. Maintain tight sponsor oversight on CRO-managed TMFs. Even if a Contract CRO manages the TMF, the sponsor retains ultimate responsibility for its completeness and quality. Sponsors should perform regular oversight activities, such as routine completeness checks and applying a risk-based approach to ensure the CRO's TMF meets regulatory standards.


4. Organizations, especially smaller ones, need to weigh the decision to adopt an eTMF system carefully. It's essential to align the investment in eTMF technology with the company's long-term goals and ensure it is supported by appropriate business processes and quality oversight.


5. When involved in mergers or acquisitions, ensure thorough due diligence on the TMF to fully understand the study's story. For regulatory inspections, having a complete, well-organized, and accessible TMF can significantly influence the outcome. A well-managed TMF supports compliance and serves as a critical tool in demonstrating the quality and integrity of clinical research to regulatory authorities.

Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.

Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.

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