The eISF Reference Model 2.0 brings new standards for eRegulatory and source document binders.
We’ve all been there before; unorganized binders, missing documents, misfiled forms. eRegulatory and source document binders offer new hope to these common problems. New tools allow for simple searching, automated audit trails and more.
The Electronic Investigator Site File (eISF) is a binder and file naming standard that brings more improvements to eBinders. The eISF was originally created by the MAGI eISF Reference Model Steering Committee, a group of clinical research professionals and vendors seeking standardized solutions for clinical trial documentation.
By using standard filing and names, there is greater consistency between sites. The wider the adoption of eISF, the easier it is for different sites to have their data compared and monitored. This also makes it easier for a sponsor to efficiently file to their Trial Master File (TMF).
Firm but Flexible
MedPoint Digital offers the eISF Reference Model binder template to all sites using Study eSafe. Study eSafe is our free eRegulatory and source document binder. Though the eISF model is a standard for all clinical trials, sites using Study eSafe can still modify the binder structure to suit their needs. Coordinators may also apply their own document naming procedure, so documents keep familiar names. Sites have the option to adopt the eISF, edit it, or create their own unique binders when using Study eSafe.
Challenges and Solutions
While the benefits of adopting this reference model are vast, it’s not without some difficulties. Currently document naming conventions can differ from site, sponsor, or monitor. File name inconsistency happens across the clinical trial industry. However, standardization will greatly help communication between all parties involved. Applying a new organization tool can be tedious but once implemented new site staff can 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.