A clinical trial protocol template serves as the standardized framework for developing a study's master plan. It is the foundational document that ensures all critical scientific, ethical, and operational details are structured in alignment with regulatory standards and Good Clinical…
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…
For decades, clinical trial documentation consisted of extensive paper records—binders stored in file rooms, often across different locations. The Trial Master File (TMF) was a physical artifact, assembled and managed through manual processes. Today, this paradigm has shifted. An electronic…
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…