Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks
Keywords:Data coordinating center, Multicenter research, IRB approvals, Electronic tools, Documentation tracking, Protection of human subjects
Background: Data coordinating centers (DCCs) for multicenter research networks are often responsible for tracking clinical center (CC) IRB approvals. In networks with multiple studies the volume of documentation can be challenging to manage. DCC informatics specialists and coordinators developed simple electronic tools and processes to fulfill this responsibility.
Methods: Informatics specialists created a Microsoft Access database to track receipt of IRB approvals from CCs. The database monitors approval expiration dates for an unlimited number of studies and CCs and generates automated reports displaying information on all documented approvals. Coordinators formalized communication procedures for collecting approvals and disseminating information on file. The DCC established a central e-mail account to which CCs submit documentation. The DCC sends monthly e-mails notifying CCs that updated IRB reports have been posted. CCs determine what documentation must be sent to the DCC, and the DCC verifies that all submitted documentation is valid.
Results: The database increased DCC efficiencies with a semiautomated mechanism and standardized procedures. New communication processes strengthened compliance with regulatory guidance and client requirements to monitor data collection with appropriate human subjects protections in place. The IRB approval-related e-mail volume sent to CCs was reduced. Automated highlighting of approvals expiring soon reduced DCC coordinator efforts and minimized potential for noncompliance.
Conclusions: Although initial investment is needed, formalization of the database and processes result in resource savings throughout the organization’s tenure as a DCC. The flexible nature of access databases makes them an efficient solution for tracking IRB approvals in networks with fluid center compositions.
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