Tag ICH GCP

Clinical Documentation, FDA / EMA / ICH, Regulatory & Compliance

A Guide to the DIA Trial Master File Reference Model

The volume of documentation generated during a clinical trial is substantial, and its organization is a critical operational and regulatory requirement. The DIA Trial Master File (TMF) Reference Model provides a standardized framework for this purpose. The model is not…

mitch
December 21, 2025

Clinical Documentation, FDA / EMA / ICH, Regulatory & Compliance

A Guide to Regulatory Document Management Systems in Clinical Trials

A regulatory document management system (RDMS) is a specialized platform designed for authoring, managing, reviewing, approving, and archiving the extensive documentation required for clinical trials and regulatory submissions. Unlike a general-purpose digital filing system, it functions as a controlled environment…

mitch
December 19, 2025