Hey, Clinical Trial Study Teams - Let's Go eTMF Mobile

By Larissa Polejaev, Product Owner, myTI

Paper in clinical trials is becoming increasingly obsolete; the advantages of near-real-time transparency into clinical documentation and associated processes (TMF quality and completeness, for example) is even more important for regulators. Let’s imagine a world where the review process is much quicker: significant reductions in the transport of boxes of documents, massive reduction in risks of documentation being lost or damaged in transport (or loss due to a fire), and big savings on paper expenses, packaging, and transit costs. The amount of time that could be saved by and for the Clinical Research Associates at the investigative site by eliminating paper handling would help to keep everything in order, reduce the need for assistance from the office staff regarding security/passwords for printing and scanning machines, and negate the transfer and upload of the now-digital TMF documents into the eTMF. If no scanner exists at the facility (or it is broken, or perhaps the CRA does not have their own portable scanner) the CRA might have to photocopy the TMF and site documents and only then, once they’re at their home office (which could be weeks later), do they have the opportunity to scan and upload the documents. Such situations delay the documents anywhere from 30-60 days to getting into the system after the CRA’s site visit.

A mobile experience tailored to these processes could streamline and simplify the process using our own personal mobile devices to get documents quickly and safely into the TMF in real time while the CRAs are at the investigative site. CRAs and managers could get immediate access for comparing and reviewing the documents in the system and easily review document statuses, resolve queries, and view TMF completeness at a glance with visual reporting. Frequently Asked Questions, links to other portals used for the particular study, and a listing of study staff assigned at the site for the particular study also gives the CRA the opportunity to have all relevant site information, literally in the palm of their hand.