Electronic Trial Master File (eTMF) resources for Investigator Initiated Trials

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This eTMF has been developed by Sydney Health Partners and the University of Sydney Clinical Trials Support Office to help researchers organise and manage clinical trial documentation.

Good documentation is vital in clinical trials. Electronic Trial Master Files (eTMFs) are the preferred way to document your clinical trial from beginning to end, and should include all documents, images and other digital content, allowing compliance with guidelines and regulatory bodies.

Sydney Health Partners has worked with the University of Sydney Clinical Trial Support Office to develop an eTMF file directory and associated guidelines for you to use when conducting your clinical trial.

How Do I Use the eTMF?

  1. Download the eTMF, Guidelines and Table of Contents documents linked in the Downloads box of this page.
  2. Extract the items in the compressed (zipped) folder containing the eTMF template table of contents and folder structure.
  3. Add and/or update the table of contents and the corresponding folders as appropriate for the conduct of your clinical trial.
  4. The shaded sections of the Table of Contents indicate the minimum requirement of documents (as applicable) before the clinical phase of your trial commences. Refer to section 8, “Essential Documents for the Conduct of a Clinical Trial”, of the ICH E6 guideline. This provides a list of the documents that should be kept by an investigator/institution and trialsponsor.
  5. Standard operating procedures (or notes to file) should be used to maintain a record of the location(s) of trial records (including source documents), trial-related procedures and/or the risk-based management of the eTMF.

For more information, read the guideline document, or contact Joan Torony, Clinical Trials Manager Sydney Health Partners (joan.torony@sydney.edu.au)