In our last blog post, we described how a simple TMF map can help orient present and future team members to the locations of documents that might otherwise be lost to history. Today we introduce a new wrinkle to the discussion: Time.
Many TMF documents are moved from one location to another over time. For example,
- A CRO maintains study-specific training records in its Learning Management System until the end of the study, then forwards them to the primary TMF repository.
- A CRO maintains a primary TMF repository until after the Clinical Study Report is finalized, and then it transfers all the documents to the sponsor, who maintains them in the sponsor's TMF repository.
- After a certain period of time, the sponsor archives the documents in its study-specific TMF repository, either locking them down or moving them to different electronic repository.
If our documents are moving around in this manner, our TMF map must cover four time periods:
- During the study
- Post-transfer of key documents to the CRO holding the primary eTMF repository
- Post-transfer of documents from the primary eTMF repository to the sponsor
- Post-archival
Suddenly our simple TMF map has gotten complicated. It may even cause us to question our assumptions. Is there a good reason to hold documents in multiple locations until the end of the study? Is there any option for archiving TMFs "in place," rather than transferring them to a different repository for archival? Are all of these repositories adequately protected and QCd? What in this process is adding value, and what is increasing risk?
This is why it's best to start with a TMF map at the beginning of the study - as an aid to planning - rather than at the end, as a mere aid to navigation.
