Ongoing Diligence is the Key to Efficient Trial Master File Upkeep
2019 is almost halfway over – how did your business fare with its TMF during the first half? In an honest assessment of the health of your organization’s trial master file, could you honestly say that there is no room for improvement? Is there anything that could be better? More organized? Less last-minute?
This is the perfect time (or any time is, for that matter) to make some actionable resolutions to achieve and maintain a TMF that is always inspection ready. Begin by performing a health check to see if your eTMF or TMF is operating correctly, if documents are properly filed, and if there are any outstanding tasks. Once you have an idea of the status of your trial master file, you can begin to develop a plan to improve it.
Following are some best practice tips to help your company do exactly that and avoid the panic and frustration that often come along with the news that an inspection is looming:
- Show Responsibility and Accountability: You’ll want to demonstrate transparency and traceability in an oversight plan by accurately documenting who is responsible for various tasks regarding the TMF including activity logs, meeting minutes, artifact review, etc.
- Create a Governance Process: Whatever process you put in place should be clearly defined in an oversight plan created by a team in your organization. Be sure that your vendor has SOPs in place to govern the TMF procedure properly, along with any services that will be provided.
- Implement a Quality Management Plan: This quality management plan should be a risk-based one. Build out strategies that focus on the identification and management of risks to the integrity of your data. Keep in mind that GCP risk-based management needs to include feedback from every used site.
- Run a Mock Inspection: In fact, run your team through mock inspections regularly. This is going to not only ensure that your TMF is kept in top shape and omissions or errors are identified and remedied before an inspector comes, but it will also lessen stress before the next actual inspection is scheduled.
- Grant Access to Systems: Make sure you are ready to provide an auditor or inspector with facilitated and direct access to the electronic systems that hold your TMF content. Even if there are documents not primarily stored in the TMF, an inspector may want access to those, as well. Be prepared to grant that access.
- Submit Content Regularly: This may be the single most important thing you can do with your TMF. From day 1 of your trial, operate with a preparatory mindset as opposed to a reactionary one; file documents on a timely basis, rather than all at once in a panic once word is out of an upcoming inspection.
In addition to those six important tasks already mentioned, if you have an eTMF, you should align artifact exchange with the eTMF-EMS standard by automating processes. This will improve compliance with SOPs. Gather feedback regularly from all stakeholders and engage with your team often. Encourage collaboration by implementing a centralized model and have structured procedures in place that promote a collaborative artifact exchange.
When all is said and done, remember the most important thing you can do to improve your TMF is to always operate with the understanding that tasks are to be done regularly, instead of last-minute in a frenzy once an inspector is scheduled to arrive.
Searching for more tips, ideas, and up-to-date information on managing TMF processes? Attending a trial master file conference on the subject may be exactly what you need; reserve your space at an upcoming event today and hone your skills with managing trial master files.