Document processing in the trial master file (TMF) can be a laborious activity, checking each document to make sure everything is correct and pushing those documents through or rejecting them depending on the result of those checks.
The benefit of eTMF software systems is that they allow companies to look at the bigger picture and be more proactive with TMF processing steps. While each solution has its own set of capabilities, the overarching benefit of any system agnostic document processing solution is the ability to reduce document checks, work faster, and be more productive.
To tap into these advantages, there are top five best practices we recommend you follow.
- Follow the guidance at the sponsor level for processing documents. It’s not uncommon for each stakeholder to have their own ways of working with documents but given the sponsor retains responsibility for oversight it’s vital that everyone works to the sponsor’s processes.
- Establish key performance indicators (KPIs) for measuring document quality. For example, set up expectations for the processing of documents from creation to finalization as part of the service level agreement. While setting up these KPIs may take a while, they can be applied to all other studies the sponsor has. Check with your vendor what type of oversight and reporting capabilities they have in their software and request reports to ensure this is properly carried out. A good software solution should provide you with all the data you need to focus on reviewing and working on improvements for KPIs.
- Retrain users as needed. If you see your users aren’t following the guidance, it might be time retrain them on the software. Make sure this training isn’t simply a video on how to log in and upload documents, but also that you explain why certain activities need to be completed in the eTMF software. For example, if checks aren’t carried out it will affect completeness; if something isn’t flagged appropriately it won’t show up in reports and will be overlooked.
- Make sure there aren’t barriers to managing simple fixes in your software. We had one situation with a client whose software only permitted a pass or reject of the document, rather than allowing us to fix issues, such as problems with rotation, blank pages, links to documents, and so on. The client went back to their software provider to update their solution and allow permission to make those fixes. The ability to find and fix issues should be enabled to improve document processing practices, rather than having to go back to the document owner for simple fixes.
- Escalate quality issues as needed. Raising issues on a document is one thing, making sure they are resolved in timely manner is another. Make sure quality issues aren’t open for longer that needed (per agreed deadline), that all owners receive feedback on open queries, and, if needed, that those are escalated along a pre-agreed path.
Following best practices with document processing will help sponsors improve the quality of the TMF and achieve their objectives with completeness, timeliness, and quality.
About the author:
Justyna Alsztyniuk is lead customer success manager at PharmaLex, responsible for advising customers about solutions that would best serve their eTMF needs and helping them achieve their goals. In her role within the customer success team, she draws on her experience at both large and small pharmaceutical companies.
