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A Guide to the Clinical Trial Protocol Template
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 Practice (GCP). Understanding the Protocol as a Foundational Document The clinical trial protocol is the
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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 a regulation or a legally binding requirement. Instead, it is an industry-developed standard that offers
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A Guide to Electronic Trial Master File Software
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 Trial Master File (eTMF) system is a specialized software platform designed to manage clinical trial
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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 specifically built to adhere to the stringent requirements of regulatory bodies such as the FDA