Clinical trials generate reams of documents. Many of these documents are produced for specific purposes or audiences and are subject to detailed requirements that govern everything from format type to the environment in which the file is produced.
As documents and their requirements proliferate, so does the burden on clinical trial and medical affairs teams to meet those requirements. To add to that burden, the teams must also be able to accurately track and provide essential evidence about the documents when requested by regulators and other parties.
“Today’s healthcare data management systems are facing key challenges in terms of data transparency, traceability, immutability, audit, data provenance, flexible access, trust, privacy, and security,” noted Ibrar Yaqoob and fellow researchers in a 2021 article in Neural Computing and Applications.
Before the digital revolution, a trial master file long served as the repository for necessary documents and logs and was maintained in a physical format. Today, the use of an electronic trial master file (eTMF) can streamline much of the work of document management, logging, and compliance.