Challenges, Change, And The Future Of eTMF

By The TransPerfect Life Sciences Team

The TransPerfect Life Sciences Trial Interactive team was excited to attend the 2017 TMF Summit in London this October, where discussions on the movement from paper to eTMF continued to be a focus.   At recent industry conferences, including both the Trial Master Files and Inspection Readiness (September 2017 in Amsterdam) and the TMF Summit, challenges were echoed by sponsors, CROs, eTMF providers, and regulatory agencies. While progress has been made in areas such as eTMF Reference Model adoption for index structures and metadata artifacts, it is clear that challenges still persist amongst the industry and TMF stakeholders. Regulatory authorities shared key insight and updates related to some of the reflection papers and regulations. As an example, EMA talked about eTMFs in final review, and the most recent July 2017 Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials that will come into effect in 2018 or shortly thereafter.