eTMF Access: A New Industry Challenge
By Sharon Ames
The pharmaceutical, device, biotech, and CRO industries are now fully immersed in the use of electronic solutions to manage trial master files (TMFs). The practice of maintaining a study's paper documents in filing cabinets and file rooms located throughout various global locations is quickly becoming rarer, replaced by one amalgamated electronic trial master file (eTMF) per study.
Industry leaders in this arena should be praised for their part in driving this technology forward, making eTMF the default solution for TMF management. However, as we implement eTMF across the industry, we're replacing the challenges of managing paper TMFs with new challenges in the digital world.
When marketing the eTMF, we hang our hat on access, arguing that study teams can gain 24/7 access to the study files to assist them in their job. But is this true? Consider the following scenarios, which may suggest we've become access challenged.
Scenario One: The sponsor is working with a CRO. The responsibility for maintaining the TMF remains with the sponsor using its eTMF. The CRO sends all paper documents to the sponsor on a monthly basis. Upon receipt, the sponsor scans and uploads the documents into the eTMF. The sponsor's SOPs do not allow external customers to access the TMF. In order for the CRO to do its job effectively and to have a record of what was sent, the CRO makes electronic copies of all documents submitted.
Challenge: Creating two electronic images of a document is inefficient and increases the overall cost of the trial. This also adds complexity to document retention policies, and it could create regulatory and legal risk with multiple versions of documents maintained in two organizations.
Scenario Two: The sponsor has outsourced all services to a CRO. The CRO is responsible for managing the TMF using the CRO eTMF. The CRO SOPs do not allow access to external customers.
Challenge: The sponsor access is no different than its previous access in a paper world. The sponsor is forced to travel to the CRO to perform periodic file reviews. Workarounds are possible, e.g., file exports to DVDs, but they're inefficient and costly.
Scenario Three: The sponsor has delegated the responsibility of managing the TMF to the CRO. The CRO eTMF will be used. The CRO SOPs allow sponsors to have 24/7 read access to the eTMF. Read access will allow the sponsor to view its files remotely to ensure the quality of the TMF and to retrieve documents needed during the trial. The sponsor cannot contribute documents to the file.
Challenge: To have a complete, final TMF at the end of the study, both the sponsor and the CRO need to contribute documents. Without contributor access, the sponsor is forced to maintain a separate TMF and either merge the documents at the end of the study or archive them as two separate TMFs. Again, this is inefficient and costly.
Solution
Externalization. Allow external customers to access, view, and contribute documents to the eTMF. With controlled, role-based access, both the internal and external customers will be able to perform their trial-related tasks, contribute to the TMF on an ongoing basis, and ensure the TMF is inspection-ready at any point in time.