DOI: http://dx.doi.org/10.18203/2349-3259.ijct20190255

Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks

Jenna H. Gabrio, Jeanette Auman, Lindsay Parlberg, Margaret Crawford, Kristin Zaterka-Baxter

Abstract


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.


Keywords


Data coordinating center, Multicenter research, IRB approvals, Electronic tools, Documentation tracking, Protection of human subjects

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References


National Heart, Lung, and Blood Institute. Data coordinating centers’ best practices. May 23-24: Available at: https://www.nhlbi.nih.gov/events/ 2011/data-coordinating-centers-best-practices. Published 2011. Accessed on 20 September 2018.

Rockwell S. The FDP Faculty Burden Survey. Res Manag Rev. 2009;16(2):29-44.

Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):5.

National Center for Biotechnology Information. HIPAA, the Privacy Rule, and its application to health research. Beyond the HIPAA privacy rule: enhancing privacy, improving health through research. Bethesda, MD: National Acad Sci; 2009.

Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol. 2006;59(8):784-90.

Marsolo K. Approaches to facilitate institutional review board approval of multicenter research studies. Med Care. 2012;50:77-81.

Tsan MF, Nguyen Y. Lapse in institutional review board continuing review approval. IRB. 2015;37(2):14-9.

Department of Health and Human Services, Office of Human Research Protections. Continuing review guidance. Available at: https://www.hhs.gov/ ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html#section-h. Published 2010. Accessed on 19 September 2018.

McNay LA, Tavel JA, Oseekey K, McDermott CM, Mollerup D, Bebchuk JD, et al. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience. Control Clin Trials. 2002;23(1):59-66.

Wolf LE, Walden JF, Lo B. Human subjects issues and IRB review in practice-based research. Ann Fam Med. 2005;3(1):30-7.

Yawn BP, Graham DG, Bertram SL, Kurland MJ, Dietrich AJ, Wollan PC, et al. Practice-based research network studies and institutional review boards: two new issues. J Am Board Fam Med. 2009;22(4):453-60.

Collins JF, Garg R, Teo KK, Williford WO, Howell CL, DIG Investigators. The role of the data coordinating center in the IRB review and approval process: the DIG trial experience. Control Clin Trials. 2003;24(6):306-15.

Abbott D, Califf R, Morrison BW, Pierre C, Bolte J, Chakraborty S. Cycle time metrics for multisite clinical trials in the United States. Ther Innov Regul Sci. 2013;47(2):152-60.

Microsoft. Access: elevate data. Availabe at: https://products.office.com/en-us/access. Published 2018. Accessed on 20 September 2018.

RTI International. MS Access database with custom Visual Basic functionality programmed by Jeanette Auman housed on RTI private data servers. Research Triangle Park, NC: RTI International; 2007.

National Institutes of Health. Single IRB policy for multi-site research. Available at: https://grants.nih. gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm. Published 2018. Accessed on 20 September 2018.

National Institutes of Health. Single IRB review for multi-site research resource and infrastructure development workshop. Available at: https://osp.od. nih.gov/wp-content/uploads/sIRB_Relevant_ Information_and_Resources.pdf. Published 2018. Accessed on 20 September 2018.