Jennifer Sodrel

Institutional review boards (IRB) are independent organizations officially designated by the FDA to review and monitor research involving human subjects. An IRB's primary responsibility is to ensure that all appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research, both before and during studies. IRBs serve a vital oversight role in the drug development and clinical trial process. In accordance with FDA regulations, the IRB has the authority to approve, require approval modifications, or disapprove research.

"The problem of clinical trials generating mountains of paperwork is legendary," said Louis Pozzo back in 2005

  and not much has changed. The mountains of paper and the time to manage it represent an enormous expense to study sponsors, contract research organizations (CROs), and the environment.

  The review of protocols by the IRB is no different. Running the day-to-day business of an IRB requires a great deal of internal and external collaboration, managed by strict access controls. As a result, the process is incredibly document-intensive—a situation with inherent legal and compliance shortcomings, not to mention the time and money spent on document tracking, transporting, and archiving, let alone the paper itself. 

Copernicus Group IRB (CGIRB), based in Research Triangle Park, NC, is a case in point. In 2006, 10 years after its founding, the company started an initiative that would soon make it the first large-scale IRB to transition to electronic paperless management of the entire clinical trial review process. 

In 1991, FDA began discussions on the use of electronic records in lieu of paper records, resulting in the issuance of the final rule "21 CFR 11" in 1997

—it took some time after that for organizations to interpret these guidelines and become truly compliant. In the case of CGIRB, by 2006, fully 96% of documents submitted to the IRB for review were received electronically via digital fax, portals, and e-mail.  

New guidelines stipulated that regulatory decisions could not be made on any electronic document that did not meet Part 11 Validated System requirements. CGIRB had not yet conformed to Part 11 at this time; thus, all incoming electronic documents had to be printed out on paper and filed in the individual study and investigator files (within a regulated, access-controlled file room) for audit and archival purposes. Copies were also created and couriered to board members for review. Compounding the issue, whenever a member of the review board needed to access archival documents, a CGIRB staff member had to search through the massive paper archives and then courier printed copies to the board member. After review, the signed outcome letters were again copied and shipped to clients and sites, filed, and stored. 

CGIRB was generating the equivalent of a 22-foot stack of paper every week—approximately 55,000 pages, or 2.86 million pages per year. These physical documents needed to be managed, circulated, filed, stored, and ultimately destroyed. Because research studies can continue for 10 years or more, the number of legacy paper documents that had to be kept available for review was staggering—and growing daily. 

When CGIRB first began reviewing ways to reduce its production of paper documents, the company's goal was simply to develop a new way to handle incoming electronic documents. However, early in planning, CGIRB realized it was possible to become a completely paperless company throughout the entire review process, including the archives. 

Reduce time associated with file requests, audits, and submissions

Enable full-text search of all live and archived documents

Protect and archive institutional knowledge

Reduce the need for paper for cost, shipping, storage, and environmental reasons

In the end, CGIRB scanned 1.5 million legacy documents—totaling 5 million pages—plus all outcome documents and all inbound paper and electronic documents. The company also reinvented every single process and workflow it had developed in its 10 years in operation, including extensive systems integration with its internal protocol tracking system and customer-facing portal. Perhaps most importantly, the project stimulated a new culture of change management and innovation for CGIRB's employees. Today, 98% of CGIRB's operations are managed electronically from start to finish. 

As an outgrowth of this conversion initiative, CGIRB was able to launch an entirely new electronic collaborative process known as CGIRB Connexus®  through which study managers, CROs, and the IRB could interface. Built on the Xerox DocuShare®  platform, Connexus captures and electronically manages every stage of IRB documentation—a comprehensive tracking/audit database and electronic document repository that solves the complications inherent in managing ethical review of clinical research protocols.  

Acting as a "command center" for the entire IRB review process, Connexus provides CGIRB, study managers, sponsors, and CROs with 24/7 access to manage submissions in motion. It also provides study managers with unprecedented new oversight capabilities that transform the entire IRB review process. Fully FDA 21 CFR Part 11 compliant, Connexus provides a full audit trail, enabling client organizations to fulfill regulatory demands quickly and completely. 

Enables more efficient and precise board reviews

Allows unprecedented Internet access to documentation

Speeds and eases sharing and transporting massive amounts of information

Improves review cycle times by reducing time to process requests from one hour to several minutes

Reduces time for employees and auditors during routine FDA and sponsor audits

Reduces time and money spent on storage space, document handling, shipping, supplies, and personnel

Accelerates the clinical research start up cycle, allowing companies to get drugs to market faster

Reduces administrative tasks, allowing CROs to function more strategically

Allows immediate 24/7 access to review status

Provides easier study transition from startup stage to project management stage

Improves customer service through greater transparency

Allows the CRO to review study status and completion of site documentation

It is important to note that a very strategic staged-in approach was necessary to take an organization of this magnitude paperless while maintaining compliance, effective audit trails, and the ability to locate a document at any point in time in the process. Others embarking on this process would benefit from a similar approach.   

Stage one implemented Xerox's DocuShare document management system out-of-the-box to introduce employees to the system's basic navigation and use. Non-regulated documents were used so that staff could become familiar with the system without interfering with protocol and security. 

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Going paperless can help an IRB quickly collaborate, share documents, and review protocols.

Jennifer Sodrel

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