The transition from paper to electronic Trial Master File (TMF) system, is a significant task, which is further complicated with the varying views and opinions complicating the route to standardisation. This is partially solved by the new directives under construction alongside the EMA’s updated information providing giving insight into inspector’s reviewing behaviours and what has been examined as of late for eTMFs. These much needed points of clarification help inform pharma and biotech companies on how to best create and maintain an eTMF system.
Mapping And Tracking Your Route to an eTMF
It requires a considerable amount of effort and money to implement an eTMF system. This coupled with the multiple complications with implementation, inevitably means that solid aims, goals and objectives are vital for success. Examples of key objectives, which support the existence of an eTMF as well as guiding optimal maintenance, include:
•Maintaining TMF transparency: In the face of different studies featuring a range of compounds which will cause TMFs to vary from case to case sponsors and CROs should aim to maintain astandardised level of TMF knowledge and transparency throughout each and every study.
Process implementation and adaptability. Finding the right process for your company and utilising this method to the best of its ability using an outsourced system. Third party eTMF systems may cause this to become prominent and will demand theadaptation and introduction of new processes where required.
It’s important to ensure that the team is willing to adapt to the new process for the eTMF, which might not occur naturally. Training is going to be a likelynecessity for a handful of people within the business.
•Maintaining TMF inspection readiness at all times: Complying to relevant regulatory guidelines – including theICH GCP. View our infographic on being inspection ready here
•Increasing productivity, and effectivity to processes
Depending on the filing structure, the transference to an eTMF can be straightforward. Although, if amends are made to the filing structure in parallel to the transference to an eTMF, a lot of confusion can be encountered as this creates a huge migration project.
Key management metrics: This is useful for the maintenance of an eTMF system and can be more involved than with paper format. With paper it is fairly straightforward – a person could pull out the binders, review timelines and apply their knowledge to define a status with a TMF.
The measurement of TMF’s quality is vital, using either QC or QA measures. To do this for any eTMF programme one needs the right tools and processes to monitor progress, quality and archiving procedures. Close internal collaboration will be required to devise the certain stages for this.
Increasing and maintaining a high level of eTMF quality throughout all studies.
Implementation Hurdles
One of the downfalls to the implementation of an eTMF is the expense required. In comparison to a paper TMF, it costs considerably more to Implement an eTMF study,especially with a debut eTMF study. There are various updated directives focusing tightly on eTMF, like the ICH GCP addendum. As part of the implementation process consultants may be required to review and realign internal processes to ensure everything is compliant and effective, which will require funding.
Download the whitepaper to continue reading