eISF Reference Model Overview
You’ve likely heard that the MAGI Global eISF / eReg Binder Reference Model Version 0.9 is open and available for review. By now, you may be wondering what’s next for me and my organization?
Our representative on the MAGI eISF Reference Model Steering Committee, Jordan Tapley, walks us through the possible changes in your daily routine, as well as the reasoning and goals of the committee as they collaborated on this model.
For those of you considering implementing this reference model, it’s important to be aware of the potential impact on your day-to-day and what you need to know to make the model work for your organization.
Below are a few key potential changes to familiarize yourself with.
If you are unfamiliar with the MAGI eISF Reference Model, visit this blog post first to start your research.
Potential Change #1: Standardize New Study Binder Structures (paper and digital)
This model introduces a consistent binder or folder structure that includes all essential documents that a Site needs to collect both internally, as well as externally for the sponsor.
Jordan explained that the key reasons this model establishes a standard for eISF binder or folder structures is in an effort to:
- decrease study start-up timelines
- eliminate confusion around where to file certain documents
- i.e. be aware of critical document locations for organization and especially for audits. This is an alternative to auto-filing that can create a disconnect.
- facilitate the monitor’s ability to easily locate files and ease the Site’s oversight of this process
- enable the integration of a Site’s eISF platform with the sponsor’s eTMF platform via document mapping
- standardize structures across Sites in multicenter studies for easier management
- provide a foundation for new Sites
- provide a basis of standardization for a Site in the process of centralizing regulatory processes across departments or groups
Keep in mind that this is a reference model, meaning it may not fit your study model perfectly, or at all. That’s okay. Jordan explained that the committee’s hope was for Sites to realize one or more of the benefits listed above, and over time increase standardization across the industry for smoother trial management.
Pro Tip: Standardizing your binder or folder structures is especially useful if you’re looking to integrate with your sponsors, as it maps directly to the DIA reference model.
Potential Change #2: Adjust Names of Regulatory Documents
Document nomenclature differs across the industry. For example, delegation of authority log vs. delegated task log or correspondence versus communication, etc. This model takes a stance on nomenclature based on recommendations made by the NIH, as well as terms sponsors are accustomed to via the DIA reference terms.
The utilization of this model may require a slight adjustment as to how you name documents moving forward. However, if your primary goal is focused on standardization within your own organization, you can be more flexible here.
Pro Tip: Document naming becomes increasingly important in the context of improving collaboration and connectivity with sponsors.
Potential Change #3: File Documents in a Different Area
It’s possible you will find that some essential documents you typically file in a certain area have a unique representation in the model. For example, today you may be filing your Investigator Brochure and receipt of confirmation within a safety section, whereas in the Reference Model, you’ll notice IB-related documents have their own section. Same goes for the DOA and signature logs, as well as financial disclosure forms.
Why? The MAGI initiative was to achieve more specificity for the benefit of the Site. Jordan explained that what the committee heard across organizations is that there can often be confusion around where certain documents are filed, meaning it can be tough to find them later. The challenge increases when new team members are just learning the process.
The reference model offers clear and specific guidelines as to where essential items are filed to prevent vague sections that allow for debate. While this has the potential of doubling a binder tab/folder count, the pay-off is efficiency and speed when it comes to filing and searching for those documents at a later date – both for you and your monitors/auditors.
Pro Tip: The challenge of standardization on paper is a leading catalyst for the influx of Sites that have already transitioned to an eRegulatory platform or will do so before the end of 2020. Learn more about the Florence eISF built for Sites here.
High-Level Goals of the MAGI eISF Committee
While these potential changes take shape in your mind, below are additional insights to help provide you with a deeper level of understanding in the context of the high-level goals of this committee.
Jordan explained that the committee set out to:
- Be Site-centric
- “First and foremost, the most important goal was to ensure this model made sense for Sites. Sponsors already have a DIA model. Sites need their own; in their own language.”
- Create Site/Sponsor alignment
- “We examined and aligned the eISF and DIA models where they naturally overlap, which allows for easier monitor reviews and eTMF-eISF integration.”
- Endorse simplicity and specificity
- “We found the more specific we got, the simpler it was. A place for every document and every document in its place.”
- Achieve functions that translate across both paper and eISF
- “While many Sites have moved to a paperless regulatory document workflow, not all have taken this step. This model needed to be all-inclusive, giving Sites still in paper just as much opportunity to standardize.”
Rather than completely replacing what you do each day as an organization and individual on a team, this model and it’s steering committee sought to create a standard of uniformity that will further enhance and streamline essential activities from study start-up to information exchange. Ultimately, this will advance the industry at large and lead to better patient outcomes, new treatments and advanced research.