What is a Trial Master File?
Clinical trials help establish the safety and effectiveness of medical interventions in patients. A Trial Master File contains all the documents pertaining to a specific trial. This often includes the study protocol, management plan, investigator brochure, informed consent forms, monitoring reports, and much more.
What is an Electronic Trial Master File (eTMF)?
An Electronic Trial Master File (eTMF) is any software solution that enables storage and management of essential documents and data for clinical trials. A robust eTMF allows sponsors to not only quickly visualize clinical trial progress and manage study documents, but also abide by good clinical practices (GCP).
Five Main Benefits of using an eTMF
Maximize Efficiency
Streamline the trial process by facilitating document filing in accordance with the latest reference model. By improving the searchability and traceability of study documents,...
Gather Insights
View planned and actual milestones at any given point during the study. eTMFs often offer reports and dashboards, which aid in identifying potential problems early on and tracking...
Enhance Collaboration
Sponsors, CROs, and site staff are seldom based in the same location. Teams spread across different time zones can leverage built-in tools such as workflows and document editors...
Improve Inspection Readiness
Ensure documents are present and filed correctly in accordance with the latest regulations. If a sponsor has dozens of sites at various stages within the same trial, the...
Control TMF Security
TMFs often contain sensitive information, some of which must be blinded for study personnel. eTMFs provide more advanced access permissions than traditional shared drives, which...
What are important considerations when selecting an eTMF solution?
What are important considerations when selecting an eTMF solution?
What is the tangible impact of an effective eTMF?
The benefits of a well-implemented eTMF span far beyond your organization’s clinical team. Consider the following scenarios:
- Leadership plans to discuss highly anticipated trials during the quarterly town hall. The eTMF enables them to access trial information more readily.
- Clinical Research Associates (CRAs) use eTMF to remotely access the ISF. By doing so, CRAs can shorten site visits and save department costs.
- Legal needs to reference trial information that may be involved in litigation. Before the eTMF was implemented, files were often edited with little visibility into who made what change. Now, the eTMF System Administrator may place a hold on documents, ensuring no users are versioning or deleting it.
ProPharma's eTMF Expertise
If you are interested in implementing or optimizing eTMF, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!
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