eReg Benefits for Clinical Research: Use Cases for all Types of Sites
Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. While regulatory management can take significant time and effort, utilizing an eRegulatory system can help staff increase productivity, improve compliance, and save money.
Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows. A 21 CFR Part 11 compliant system, eReg can benefit any type of organization, from the biggest academic medical centers (AMCs), down to individual research sites. This blog shows different eRegulatory use cases for different types of sites, as well as eRegulatory capabilities designed to serve all sites.
AMCs and Health Systems
Integrating a clinical trial management system (CTMS) enables the regulatory team to pull protocol details and place them into eReg. This saves organizations time while also ensuring consistency between information added in each platform. Once documents are filed and signed in eReg, they can be sent back and made available their CTMS.
For multi-site protocols, AMCs, cancer centers, and health systems can set up their protocol structure so it benefits them as the coordinating center. This allows staff to track their coordinating center documents, the participating sites, and documents the coordinating center files for each site. With document integration for multi-site protocols, coordinating centers can also send documents to every site simultaneously.
Utilizing an eReg system also allows for centrally managed credential and organization regulatory documents at AMCs and health systems. This ensures when an update is made for a staff member’s credential – or a document added for an organization – the new document automatically flows into any protocol the record is used on. This saves staff members time since they do not have to look up individual records to make sure credentials are present for each one.
Typically, site networks create and run a study as the coordinating center, and need to manage regulatory documents for participating sites on the study. Using an eRegulatory management system enables site networks to centrally manage their multi-site protocols while simultaneously connecting each site as they use the same system. This also lets documents flow between the multi-site protocol and sites, all within the same eReg instance.
As a single site participates on a protocol, they can connect to an eReg platform their coordinating center is using, and send their documents to the center from within their own eReg instance. If a site is using Advarra eReg, they can also receive documents from the coordinating center directly in the protocol inbox, making filing and organization easier as well.
Additionally, for sites using the Center for IRB Intelligence (CIRBI), they can integrate it with eReg. This allows studies to receive their IRB-approved documents directly into their protocol inbox from CIRBI. With this integration, staff won’t have to log into the IRB system, download the documents from that system, and re-upload them into eReg. This saves them time and reduces the chances of situations such as documents being uploaded twice or the wrong documents being updated into the system.
Similarly to AMCs, single sites have the ability to centrally manage credential and organization regulatory documents. When a staff member’s credentials are updated, or a document is added for an organization, this new document can automatically flow into any necessary protocol the record is used on.
All Types of Research Sites
While there are many organization type-specific benefits to using an eReg management system, there are plenty capabilities of the system designed to benefit every kind of organization. Additional benefits include:
- 21 CFR Part 11-compliant electronic signatures: save users time to route for signatures, and ensures the organization remains compliant in their electronic signature usage.
- Mobile signing: allow staff to sign documents from their phone, no matter where they are.
- Electronic delegation of authority: a comprehensive and compliant delegation of authority log to be kept directly within the eReg system.
- Regulatory templates: save time and eliminate redundant workflows by using predefined, templated builds for each new protocol.
- Standard operating procedure (SOP) management: store SOPs in a central location, making it easy to find the latest SOP and share it as needed. eReg also can enable SOP-only review sessions, giving monitors access to SOPs during the site selection process.
- Email integration: Input documents into the system easily, and have the ability to forward email correspondence or other documents received in email inboxes.
- Investigational new drugs (INDs): Storage for INDs.
- Review sessions: Enable organizations to grant limited eReg access to both internal and external monitors in order to more easily review documents.
As you work to streamline regulatory management, it’s important to understand all the ways an eReg platform can benefit your organization. Centralizing and integrating regulatory management processes and technologies is pivotal to successful operations at any site.