What is a Trial Master File? 

During a clinical trial, a multitude of essential documents are collected to manage the study and verify whether the trial has been conducted in line with the applicable regulatory requirements and Good Clinical Practice (GCP) standards. This collection of documents makes up the Trial Master File (TMF). Since a TMF assists with evaluating the conduct of a trial, its management and upkeep are crucial. 

Paper-based TMFs came first and are still used by many organizations to this day, where paper documents are filed in multiple folders. This tends to include a greater likelihood of oversight and error as it can be difficult to keep track of documents. Consequently, this often requires having a separate tracker to document what has been filed and what has not. Since this process is time-consuming and involves multiple steps, compliance may be relatively poor. Non-compliance can then lead to delays during study close-out, as a large amount of time may need to be spent reconciling all the relevant documentation to form a clear and legible TMF.  

Electronic TMFs (eTMFs) provide a centralized system to manage essential documents collected during a clinical trial. Despite this new technology, many organizations are still hesitant to switch over due to implementation costs, insufficient training and knowledge around eTMF setup and management, and knock-on effects of process changes on organizations. However, it is important to consider the large number of benefits eTMFs offer. 

Benefits of eTMFs over paper-based TMFs:  

  • The digitisation of TMFs means that less time can be spent managing the upkeep of the TMF, reduces costs associated with TMF maintenance and ensures a faster trial close-out.  
  • When appropriate quality control (QC) checks are implemented to manage an eTMF, this enhances document quality and guarantees that the eTMF is audit-ready at any given time.  
  • eTMFs do not require any physical storage, whereas paper TMFs require large amounts of storage space in a climate-controlled environment. This also means that archiving a study after it has concluded is much more time-efficient and less costly as no large shipments need to be sent with the TMF binders to the sponsor. 
  • Sponsors, CRO, and site staff can gain remote access to the eTMF through a secure login, and appropriate users can be assigned to restrict access to certain folders and to perform document actions.  

As eTMFs provide a speedy, streamlined process to manage essential documents during a clinical trial, this technology becomes more and more attractive to sponsors and CROs. Ultimately, eTMFs provide that one extra boost to further fast-track drug and medical device development, so that it may reach those who need it quicker.