Benefits, Challenges, and Future Directions: Making the Case for eTMF in Clinical Research




Beckham, Amber C.


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In clinical research there are many documents that must be retained in order to evaluate a trial, known as essential documents and collectively held in a trial master file. A trial master file can show if a trial was conducted according to regulatory standards. Traditionally this file has contained all paper documents, but with the advancement of technology, an electronic trial master file is now available. Although the technology of electronic trial master files exists, some organizations are still reluctant to make the switch from paper to electronic. This practicum aims to measure current opinions about the use of an electronic trial master file, as well as determine what benefits and challenges are associated with using an electronic trial master file. Finally, this project aims to show the promising future and usefulness of an electronic trial master file in order to make the case for using an electronic trial master file in clinical research. This project will use a survey of clinical research professionals working at a CRO and an illustrative comparison in order to support the hypothesis that the benefits of using an electronic trial master file compared to a paper trial master file outweigh the challenges. Participants of this project are generally in favor of using an electronic trial master file over a paper one, and they believe that using and electronic trial master file has positively impacted the role they have in clinical research. Although respondents view electronic trial master files as a good investment, they are also aware that there is room for improvement and have used their industry knowledge and experience to suggest future directions for the continued adoption and use of electronic trial master files.