MedPoint Digital and MAGI announce with great enthusiasm that the MAGI Global eISF / eReg Binder Reference Model, Version 1.0 is now presented to the public.
Filip Matakovic has been passionately involved as the MedPoint representative in the MAGI eISF Reference Model Steering Committee creating this model, which is now available to sites for their use and review.
A Long-Standing Need
Electronic Trial Master Files (eTMF) have long been utilized to efficiently manage clinical documents across the life cycle of a clinical trial. These systems increased the speed at which documentation can be gathered, compiled, and reviewed. They also contributed to a new higher quality of work reducing the errors of paper-based TMFs. The purpose of having this electronic system in place is ultimately to create a smoother process of organizing documents when compiling a TMF. From this, there was a need to organize and standardize eTMF documents, from which the eTMF Reference Model was born. This is very important because it created a useful and consistent starting point for those using eTMF systems. Standardization brought order to the utilization of this tool. In the same vein, this is beginning to happen with eReg systems.
Electronic Regulatory Binders (eReg) are seen by many as the counterpart eTMFs, the digital organizational tool that is study site facing. In many ways, this is a trickle-down effect of the proliferation and success of the eTMF sponsor side. Many documents now begin their life cycle digitally, and the glaring hypocrisy of having these documents printed and filed only to scan them and place them within an eTMF is overwhelming. As sites transition to eReg, they gain countless efficiencies ranging from less time spent shuffling paper to error reduction/increased accountability.
With more and more study sites capitalizing on the implementation of eReg Binders/eISFs, there comes a need to efficiently transmit these electronic documents across to eTMF platforms. Much like the eTMF Reference Model, eISF platforms need their own RM to bring order and standardization. Currently the process of taking this eISF and matching it to a sponsors eTMF is disjointed. This reference model provides a seamless electronic experience between the site facing eISF and a sponsor eTMF. just in its first official version, the eISF Reference Model shows great potential to bridge that gap and create compounding benefits for study sites and sponsors.
Standardization across the eISF contributes to improvements across the board of those interacting with study documents. For new sites just starting out, this gives a great jumping off point onto how to organize study documentation. For monitors new and seasoned, it eases the burden on navigating study documents from site to site. Sponsors will find that eISF to eTMF document mapping accelerates the creation process for the finalized TMF. Complex multicenter clinical ops also benefit, as viewing binders serve as an established reference model across multiple sites, engendering a familiar working structure. At every touchpoint, the eISF Reference Model can aid in making regulatory documentation more accessible and easier to handle.
Challenges and Solutions
While the benefits of adopting this reference model are vast, it’s not without some potential hindrances. Currently document naming conventions can easily differ from not only site to site but also sponsor to monitor to CRA. File name inconsistency happens across the clinical trial industry. Getting this in order will greatly help communication between all parties involved. The positive is that once implemented and after the adjustment period, new site staff can quickly jump in and work on studies from multiple sponsors. Monitors now spend less time clarifying documents and can complete certain study tasks more effectively.
MedPoint Digital and the MAGI eISF Reference Model Steering Committee urge sites to adopt this new model to work towards a paperless ecosystem within clinical trials.