By Carl Dietz
Over the past 10 years, the Clinical Trial Master File, or TMF, has evolved into a powerful and digital “single record of truth” known as the eTMF. This evolution of the eTMF was driven by the industry’s practical need to digitize all the essential documents of a clinical trial.
An eTMF itself is not an automation solution for managing essential documents. Think of eTMF as a highly organized electronic file cabinet. Even if you assign users rights to upload, approve or reject document versions, essential document workflow is still missing. Most eTMFs cannot track a document’s history, its edits or any collaboration around each document. That leaves the entire essential document workflow in manual mode without an automation solution.
eTMF automation represents an opportunity to cut millions of dollars in expense while ensuring that clinical trial regulations are followed with technological precision. When we talk about eTMF automation, we are talking about automating all the manual processes that move essential documents back and forth from the first site startup of a trial until the study is closed. eTMF automation must support digital document exchanges between the trial sponsor and the trial investigators.