Five Ways to Get the Most Out of eRegulatory and Source Document Binders

Post By Knute Martell

If you’re using eRegulatory and source document binders, these tips will take your team to the next level.

When I first started using eRegulatory binders, I didn’t realize how much they could do. Now, I offer customer support to clinical research sites and I’ve found the following five things to be the most common “Aha” moments. These tips help get the most out of an eRegulatory system and improve site team efficiency and quality along the way.

Manage common documents

A common document binder includes CV’s, licenses, training certificates, temperature logs, etc. Having a common document binder allows sites the ability to share that one binder with a sponsor and not have to manage copies of the same document across multiple studies. These binders allow sites to accelerate their study start-up by reducing the time needed to manage these documents. MedPoint Digital’s free eRegulatory and source document binder, Study eSafe, has a shared binder for common documents. Study eSafe supports expiration tracking, eSignatures, and document up-versioning, frequently needed with common documents. Setting up the shared binder in Study eSafe is the best way to reap the benefits of an eRegulatory system right away and sets the stage for future study binders.

Make monitoring visits remote, but keep them in the budget

A big advantage for CRAs and sites with eRegulatory and source documents is reducing the time needed for on-site monitoring visits. Remote monitoring of eRegulatory binders and remote SDV cuts travel and logging costs for CRAs. For sites, having a CRA review files remotely reduces the need for monitoring space and is less distracting than on-site visits.

No matter the system, thoughtful preparation for a monitoring visit and review of regulatory and source documents takes time and effort. The advantage with a free eRegulatory system is that per-diem costs of monitoring visits are not diluted by the price of the platform.

Go with the (work) flow

Like any good eRegulatory system, Study eSafe supports multiple workflows for site SOPs, differing study needs, role based permissions and admin preferences. Taking a look at workflows and establishing routine processes and best practices with an eBinder system is key to being efficient. Use of the inbox function, placeholders, and document permissions are all great functions to establish efficient workflows.

The inbox function works to add one or multiple documents to a binder at once. This is a great way to get documents into your binders from disparate locations such as emails, electronic medical records, and IRBs or other systems. The most effective sites find a workflow to check and file these documents regularly.

With source documents, redacting in Study eSafe right after adding to a binder reduces the chance that they are overlooked later. Labeling sensitive or unredacted documents as “restricted” until redaction is performed is another workflow to secure PHI or sensitive information.

See one, do one, teach one

“See one, do one, teach one” is the gold standard for effectively learning a process and passing on that knowledge. This principal works well with Study eSafe’s eRegulatory and source document binders. After an admin has received a demo and set up their site preferences, they have already seen many functions and tried things for themselves. To really get the most out of the system, review the Study eSafe user guide and help videos. Advancing skills turns into time savings in the form of greater proficiency, less trouble shooting and being more self-sufficient.

When it comes time to “teach one”, people may grumble about learning a new process or system, but once they experience an easier and better way of doing things, they will never go back.

Don’t be afraid to ask for help

Leverage the customer support and experience of others to learn new things, tackle problems, and come up with solutions. If you are having a problem or are looking for a specific solution, it’s almost certain that many other people have had the same issue or needs. As someone who does a great deal of support with our users, I frequently find people surprised at how quick and simple solutions are. Often, those solutions include features that users just underutilize, forgot about or misunderstood. It’s not realistic for most people to learn everything all at once, so after settling in and working with a system, ask for help from experienced users.

To learn more about Study eSafe, a free eRegulatory and source document binder, contact MedPoint Digital today!

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