The concept of having a centralized repository of documents for clinical research projects isn’t a novel one. Decades ago, it took the shape of a physical binder, or a cabinet in the office that was full of files, faxes and forms. If one was lucky, it may have been filed in a structured manner that made it possible to search a specific bit of information that needed to be pulled out – an extremely tedious process, but possible. Over time, the physical cabinet was replaced, or supplemented, with virtual repositories on a centralized server which made the documents a little more accessible to team members from within an institution, but this process still had several shortcomings with respect to sharing documents across boundaries, efficient data searches, version management, access control and other security and compliance issues. In a domain where collaboration and process management across multiple teams is critical to the success of a project, these issues can lead to great challenges causing the trials to be delayed, fraught with miscommunication and lacking in compliance with regards to standard operating processes that would ensure delivery of clean, high quality data for reliable analysis and results reporting.

 

The quest for a better solution has led to the development of electronic content management systems that are especially designed to meet the unique needs of research in the healthcare domain. The earlier physical binder, or Trial Master Files (TMFs), are being gradually replaced by more efficient and compliant electronic Trial Master Files or eTMFs. The term eTMF encompasses solutions that are utilized for storing and maintaining digital content, including documents, images and other digital content in their original format, or those that have been converted from a different format (e.g. scanned paper copies). Sites often have their own version of an eTMF, widely referred to as eBinders. These systems are useful for sites in managing documents that are specific to their internal processes and can be supplementary to eTMFs provided by the sponsors, or used in lieu of, in case one isn’t provided or available.

 

The benefits of using a centralized electronic document repository for clinical research projects include: 

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• One accurate source of information being referenced by all stakeholders

• Highly improved ability to search and retrieve in a timely manner

• Greater control over access to the content and actions that can be performed

• Better version management and timely archiving or retiring of older documents

• Improved process around tracking release, review, approval and read acknowledgements

• Increased staff productivity and operational efficiencies in study start-up and management

• Better compliance with best practices and improved readiness for audits

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Due to the tremendous advantages that they provide, the use of eTMFs is seeing rapid growth and a study published by Industry Standard Research (ISR) in 2016 projected that the number of investigative sites having access to an eTMF provided by their study sponsor or CRO would grow from 20% in 2016 to more than 50% within the subsequent three years. Since documents and records pertaining to a clinical trial are an essential part of ensuring validity and compliance of the study, regulatory agencies have defined specific requirements and helpful guidelines for institutions that are looking to implement electronic document management systems for their research programs. These requirements include having the ability to set up appropriate security and controls for access and authority management; capabilities for tracking changes, approvals and archiving in a complaint manner; comprehensive audit trails; and ensuring that all required components, policies, controls and validations for electronic systems and electronic signatures are in place.