• DOI:10.21522/TIJCR.2014.03.02.Art009
• Corpus ID: 56843065

An overview of the importance of the Trial Master File (TMF) and the required contents in clinical trials as stipulated in the ICH GCP guidelines

@article{Venter2016AnOO,
  title={An overview of the importance of the Trial Master File (TMF) and the required contents in clinical trials as stipulated in the ICH GCP guidelines},
  author={Catharina Susanna Venter},
  journal={Journal of Clinical Research},
  year={2016},
  volume={3},
  pages={120-123}
}

• C. Venter
• Published 30 December 2016
• Medicine
• Journal of Clinical Research

Aim: The Trial master File (TMF) is a method used worldwide to collect and file documents related to clinical trials. The aim of this study was to review the ICH GCP guidelines related to the TMF and to provide an overview of the requirements of the TMF. Method: A review of the ICH CGP guidelines related to the TMF and additional resources. Topics reviewed: Six main topics was identified and discussed to provide an overview: What is a Trial Master File (TMF), the importance and benefits of the TMF, TMF and essential documents as outlined in the ICH GCP E6 guidelines from section 8.1 to 8.4, electronic TMF (eTMF), additional documents filed in the TMF Conclusion: The TMF set-up and maintenance during a clinical trial is essential to ensure all the required documents are filed and to ensure all the relevant documents are available and audit ready at all times.