An electronic trial master file (eTMF) is a digital repository of documents and other materials related to a clinical trial or other type of research study. It is used to store and organize all of the documents and information that are required for the conduct and oversight of a study, including protocols, consent forms, case report forms, investigator resumes, and other relevant documents.
The purpose of an eTMF is to provide a centralized and
organized location for storing and accessing all of the documentation related
to a study, which can be accessed by relevant parties such as the study
sponsor, the research team, and regulatory agencies. An eTMF can help to
improve the efficiency and organization of a clinical trial or research study
by providing easy access to all of the necessary documentation and information.
It can also help to ensure that all required documentation is properly tracked
and maintained throughout the course of the study.