Diligence and Routine Upkeep is Just Half the Battle with TMFs
The main role of the TMF (trial master file) is to store data in an organized way so that it can easily be accessed and reviewed for audit purposes. Essentially, the TMF is a collection of crucial documents needed in order to conduct a trial; the data must be stored, evaluated, and maintained regularly. An electronic TMF (eTMF) is a digital collection of contracts, agreements, procedures, and documents that are maintained after every trial closeout.
CROs, laboratories, sponsors, investigators, regulatory agencies, and ethics committees generate these documents – which must be updated in a timely manner and shared. There are several challenges teams face when it comes to TMF and eTMF protocol; following are the top five:
- Being Ready for an Audit
Without a doubt, the number one challenge is always having the collection of documents ready for inspection. Organizations often struggle to maintain documents properly and all too often, they wait until word of an impending inspection arrives to try to organize all the required paperwork (or files in an eTMF). If documents are not properly and regularly updated, not only can the data not be shared with anyone because of inconsistency, but there is also a huge loss of expenses and time in trying to manage compliance with regulatory authorities.
As for eTMFs, a big mistake is having documents stored in multiple locations; during an inspection, this means they are unorganized and cannot be located. This happens when essential documentation is prepared and updated by different people at different times, essentially creating a “mess”. It’s not enough to have documents residing in the system; they must be organized and accessible during an audit.
- Metrics
With TMFs, some metrics can’t be used with documents that are of poor scanning quality; in addition, it’s extremely time-consuming to monitor metrics when it comes to thousands of documents of various systems. With eTMFs, problems arise with the key parameters for metrics, which include timeliness, quality, and completeness. These must be updated constantly to keep the eTMF accurate.
- Sponsor and CRO System Collaboration
When the oversight of the CRO is limited in the overall process of filing, updating, and maintaining the TMF, reconciliation takes many hours in order to prepare properly for an upcoming audit. Furthermore, when sponsors and the CRO use different filing systems, any collaboration becomes a painstaking task. Ensure that every document that is generated is tagged and filed when dealing with an eTMF. If there are conflicts with software, and there is no integration or visibility within the filing system, the effectiveness of your eTMF will be hindered.
- Digital Process Validation
With TMFs, sponsors must ensure the validation process is sound, efficient, and effective to eliminate any loss or alteration of information – especially accidental deletion or duplication. Logistics is a key concern as documents go for approval then move to the location for digitization. One of the biggest mistakes with TMFs is not having a backup of data. Make sure with eTMFs that sponsors keep note on the validation process in order to confirm that hard copies are legitimate. Keep in mind: auditors will check for similarities between original and scanned documents.
- Making the Move to an eTMF
While some organizations still use traditional paper TMFs, electronic TMFs are advised in order to speed up clinical trials. Although the move to digital may not be a simple one at first, the time saved and increased ease of organization will be well worth it. A common mistake, however, has to do with implementation of the eTMF; the mistake is not moving from traditional TMFs to eTMFs. Using an eTMF makes the file centralized, easier to share and collaborate on, and allows your team to download and print it to compare with paper TMFs.
While these are just five challenges with TMFs, there are others, including destruction of paper documents, archival and retention, ownership transfers, and controlled access to health information. A key takeaway is that implementing an eTMF system that is integrated with all other systems is vital as a solution for these issues.
To learn more about managing your TMF accurately and effectively, reserve your seat at an upcoming TMF conference; space is limited, so sign up today to stay updated on the latest trends with TMFs and eTMFs.
