Clinical researchers spend a significant amount of time and effort to ensure compliance and safety in their trials. Billing compliance, regulatory compliance and HIPAA compliance are among the dozens of standards and processes that researchers follow to ensure a successful study. Like any business, research organizations also need to develop and comply with business continuity and disaster recovery (DR) plans to keep their operations running in the event of a natural or man-made disaster. If you’re part of a large academic institution, it’s likely your team has a well-defined DR plan in place.
However, while almost all organizations have a comprehensive set of standard operating procedures and processes for disaster recovery, DR readiness doesn’t always play a large enough part in decisions to adopt new technology. Below, we’ll examine how different approaches to regulatory management can affect your organizational readiness in the case of a disaster.
Approach 1: Paper Binders
As any clinical research veteran knows, paper binders have historically been the norm for storing essential protocol documents. While access to the physical binder may provide a sense of security for regulatory staff, these binders can be extremely susceptible to events such as fires, floods and other natural disasters. According to the National Oceanic and Atmospheric Administration (NOAA), there have been more than 2,000 natural disasters in the US since 1980 that each resulted in greater than $1 billion in damage. These represent a significant threat to organizations who rely solely on physical binders.
Approach 2: Shared Drive Systems
Over time, some research organizations have adopted a “shared drive” approach to storing regulatory documents. Whether using standard Windows file systems or slightly more advanced applications such as Microsoft SharePoint, institutions have found ways to replicate the paper binder process in a digital system.
While this method delivers some advantages over a paper process, it often fails to provide comprehensive security for regulatory documents. In cases where an institution stores regulatory binders on a locally-hosted system, a natural disaster can pose a significant threat of loss of access to regulatory data, or complete data loss. Even at institutions that have created redundancies with multiple hosting locations on their campus, a large event can potentially destroy all data in those locations.
Approach 3: eRegulatory System
A vendor-provided eRegulatory management system, such as Forte eReg, provides a safe and secure infrastructure that protects data with geographically-diverse hosting. Replicating your data at locations hundreds or thousands of miles away creates redundancies that can withstand a natural disaster. Vendors also have the infrastructure and expertise to make sure your systems are implemented correctly and securely, and can provide quick, effective support for your team.
