About this document

TMF Reference Model Overview by Arunendu Maji is a document available to read on EtoBox.

The Trial Master File (TMF) Reference Model outlines essential documents required for conducting clinical trials and ensuring data quality, as per ICH GCP guidelines. It serves as a framework for organizing trial-related records and is beneficial for sponsors, investigators, CROs, and regulatory authorities. The model is a reference tool, not a regulatory standard, and has received positive feedback from various regulatory agencies.

Author

Arunendu Maji

Language

EN