1. Retrospective Files
A TMF is not retrospective in nature. It begins with the start of a trial, and is maintained and accumulated throughout its duration.
2. Changes & Storage
TMF documents cannot be changed down the line, and data cannot be altered or removed. When files are stored electronically, they must be stored in such a way as to prevent this from happening without authorization, while creating an audit trail.
3. Physical Storage Issues
The physical storage of a document is crucial. Documents need to be kept confidential and safely stored. There needs to be protection such as environmental controls against physical damage, and everything needs to be accessible and retrievable. Vendors or subcontractors may be used for storage, however, the responsibility of the quality, integrity and confidentiality of those documents still lay with the sponsor.
4. Site vs. Sponsor TMF
These are separate documents, and while there may be crossover, they are unique. Also, keep in mind that for site TMFs, each individual site needs its own site TMF. For sponsor TMFs, there is only one document per entire trial.
5. TMF Must be a "Living" Document"
There are three stages of a TMF, and once again, it's not a retrospective file. It's an ongoing, accumulation, including before, during and after the trial.
6. eTMFs Still Need Paper Copies
There are instances where eTMFs, or electronic TMFs, still need paper copies of certain documents, mainly "wet" documents, which are signature pages, medical scans such as ECGs and X-rays, etc.
7. Poor Organization
Organization is very important with any TMF. You need to keep it chronological, have the proper labels and ordering, and have media records which are high quality. Paper copies must also be fully legible.
8. Incomplete Documents
Having a complete TMF is essential. You cannot have missing logs, incomplete entries, or any other missing components or incomplete pieces.