Knowledge and planning are the keys to successful TMF migration
This guide from Phlexglobal is designed to help you navigate the most important part of any TMF migration: project scoping and planning. Once you have a firm grasp of the three key steps listed in this brief, you will find it much easier to manage a successful TMF migration – whether performed internally or outsourced to a provider.
There’s no question that migrating a Trial Master File (TMF) is a complex undertaking. Whether converting a paper TMF, electronic documents, or a hybrid Trial Master File into an eTMF, there are a multitude of tasks that must be completed – and completed correctly in order to meet the requirements of regulatory agencies.
Fortunately, there are new tools available that make migrating your Trial Master File a far more efficient and accurate process, such as the latest version of the TMF Reference Model. The TMF Reference Model project has also published v1.0 of the eTMF Exchange Mechanism Standard (eTMF-EMS) as a specification for transferring TMF data between different eTMF systems, which should help further streamline this process. In addition, industry best practices developed over decades – from risk-based quality control (QC) to streamlined data reconciliation – help ensure a successful migration.