Finding new ways to more accurately and efficiently manage the regulatory compliance process is always a hot topic among researchers. Over the past four years, I’ve been working with Advarra customers to collaborate on the strategy and development of an eRegulatory system that addresses these needs. One thing has become clear: managing protocol documents using physical binders or an internal shared drive can put a research site in a difficult position, reducing productivity and regulatory compliance. Below are a few reasons to consider an eRegulatory system.
Centralizing your regulatory processes
Whether your regulatory department has a central body, or if you have separate regulatory offices per department, getting everyone to speak the same language and manage essential documents in the same system pays dividends in efficiency and compliance. As PI’s move from one protocol to another, or when staff change departments, having all regulatory information gathered in a standardized format will improve study start up and reduce the need for duplicate document management.
Ditching the paper and the manual document routing process
An eRegulatory system can help you avoid tracking down study staff members and PI’s by foot. It manages the legwork, notifying staff members when they need to sign and review essential documents. And by electronically signing documents and tracking them within the system, you save valuable staff time while maintaining 21 CFR Part 11 compliance.
Utilizing a single source of truth for staff credentials, training and more
An eRegulatory system eliminates the need to search the shared drive for the PI’s medical license or the protocol coordinator’s curriculum vitae across multiple protocols. The system can connect staff members to their protocols, and update credentials and training for staff members in one location and share them across all of the applicable protocols. You can also gain visibility of expiration dates for protocol documents. An eRegulatory system can run reports on expiration dates for 30/60/90 day intervals over multiple protocols, providing staff with valuable insight and allowing them to better manage their workload.
Easily preparing your site for monitor visits
Grant access to monitors to the essential documents they need to see on a site visit. You no longer need to find the binder and set it out for the monitor to ensure they are able to view the documents needed. An eRegulatory system ensures that all documentation is easily managed, all in the same user-friendly format.
What to expect from an eRegulatory system
- not only store essential protocol documents but track owners, training, expiration dates and easily route for signatures?
- manage multi-site trials, allowing a coordinating center to manage essential documents for participating sites?
- integrate with other electronic systems like email, CTMS, or eIRBs?
- manage delegation of authority workflows, including master delegation of authority?
- securely allow remote access to sponsors and monitors?