Knowledge and planning are the keys to successful TMF migration
This guide by Phlexglobal is crafted to assist you in navigating the crucial aspect of any Trial Master File (TMF) migration: project scoping and planning. Once you've gained a solid understanding of the three essential steps outlined in this concise guide, managing a successful TMF migration, whether conducted internally or outsourced to a provider, will become significantly more manageable.
Undoubtedly, migrating a Trial Master File (TMF) is a complex endeavor. Whether it involves converting a paper-based TMF, electronic documents, or transforming a hybrid Trial Master File into an electronic TMF (eTMF), there is a multitude of tasks that must be executed—each with precision to meet regulatory agency requirements.
Fortunately, there are new tools available that greatly enhance the efficiency and accuracy of the TMF migration process. Notably, the latest version of the CDISC TMF Reference Model plays a pivotal role in this regard. Additionally, the ongoing development of the CDISC TMF Reference Model Exchange Mechanism, serving as a specification for transferring TMF data between various eTMF systems, promises to streamline this process further. Furthermore, the adoption of industry best practices developed over decades, ranging from risk-based quality control (QC) to streamlined data reconciliation, ensures a successful migration is well within reach.