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Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs

At the core of daily regulatory operations are the documents required to facilitate, manage, and provide a record of the conduct of a research study. Historically reliant on paper binders, manual and redundant workflows, and burdensome monitor visits, many sites are seeking ways to streamline source document management. In the past few years, sites have increasingly turned to electronic systems to support remote workflows and keep their research moving. Facilitating remote monitoring across a site’s research portfolio is quickly becoming an expectation. To respond to these site needs, we have collaborated with our customer community to develop new workflows within our Advarra eRegulatory Management System. Continuing to transform the way essential protocol documents are routed and stored, we’ve introduced the capability to store and manage additional key study documents; subject binders and standard operating procedures (SOPs).

Store and Manage Subject Source Documents

Source documents associated with each study participant need to be stored by the research site and accessible to the sponsor for source document verification. These documents include signed consent forms, contact information, compensation records, and more. For every protocol binder, there are numerous additional subject binders to support each subject and their source documents related to the protocol, which dramatically increase your document storage needs. Ensuring proper storage of source documents is essential to the compliance and validity of your trial. Any source data captured on a paper document or in a system that does not allow controlled remote access, whether it is a signed consent form, patient diary, notes, and more can be scanned and uploaded into Advarra eReg for compliant storage and managed access for source document verification.

When you centralize your subject binders with Advarra eReg, the need to transport subject binders to multiple locations to be monitored is removed. Multiply that by the number of subjects you’re supporting across your research portfolio—the time, effort, and money you save grows exponentially.

Centralize and Retrieve SOP Documents

Not only are the processes outlined in your organization’s SOPs essential to execute in a consistent manner across your institution and participating sites, the controls in place that ensure appropriate study conduct and compliance also need to be communicated to external stakeholders. By centralizing your SOP management, you can quickly access SOP documents for internal staff and grant access to sponsor monitors, helping to bolster your organization’s audit readiness and enabling timely retrieval of any requested document.

Expand Remote Monitoring

It’s important to remember in this digital age, electronic workflows don’t automatically equate to remote capabilities. Unlike web-based systems such as SharePoint or Box, the intuitive, purpose-built workflows within Advarra eReg go beyond simply storing electronic versions of essential protocol documents, subject source documents, and SOP documents. Instead, eReg transforms the storage, upload, routing, signing, and verifying of your regulatory documents. Utilizing these workflows, your organization can efficiently and compliantly drive a complete remote monitoring process.

For example, Advarra eReg’s remote monitoring workflow supports easy access via a secure login link for the sponsor, as well full control over what the sponsor monitor can see and the timeframe for access. To increase transparency between your organization and the sponsor, you’ll also have the opportunity to view when the sponsor monitor logged into the application and what they downloaded for review.

Ensuring Scalability to Adapt to the Future of Research

Remote workflows and regulatory efficiencies will continue to be a priority and opportunity for research sites. Go beyond the binder and support your entire regulatory document management within a centralized, expanded eRegulatory system. To explore simple and efficient remote monitoring workflows, tour new storage capabilities and more, request an Advarra eReg Demo for your team.

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