Abstract
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
US Department of Health and Human Services. Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance. International Conference on Harmonisation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf. Published April 1996. Accessed March 11, 2014.
US Department of Veterans Affairs. Options for fulfilling Office of Research and Development (ORD) training requirements. http://www.research.va.gov/pride/training/options.cfm. Accessed September 16, 2015.
National Institute of Allergy and Infectious Diseases (NIAID). Good Clinical Practice training for NIAID and awardee clinical research staff. https://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Documents/NIAIDGCPTrainingPolicy.pdf. Accessed September 16, 2015.
Division of Acquired Immunodeficiency Syndrome (DAIDS). Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training requirements. https://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Documents/gcp_hsp_sitetrain_policy.pdf. Accessed September 16, 2015.
Clinical Trials Transformation Initiative. GCP training expert meeting. http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/gcp-training/expert-meeting. Accessed November 23, 2015.
Clinical Trials Transformation Initiative. GCP training recommendations. http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/gcp-training/products. Accessed November 30, 2015.
Clinical Trials Transformation Initiative. Literature review. http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/gcp-training/products. Accessed November 30, 2015.
Anderson MS, Horn AS, Risbey KR, Ronning EA, De Vries R, Martinson BC. What do mentoring and training in the responsible conduct of research have to do with scientists’ misbehavior? Findings from a National Survey of NIH-funded scientists. Acad Med. 2007;82:853–860.
DeBruin DA, Scholder SL, Kahn J, et al. Educational approaches to the responsible conduct of clinical research: an exploratory study. Acad Med. 2007;82:32–39.
DuBois JM, Schilling DA, Heitman E, Steneck NH, Kon AA. Instruction in the responsible conduct of research: an inventory of programs and materials within CTSAs. Clin Transl Sci. 2010;3:109–111.
Friedman JY, Sugarman J, Dhillon JK, et al. Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants. Clin Trials. 2007;4:272–278.
Heitman E, Olsen CH, Anestidou L, Bulger RE. New graduate students’ baseline knowledge of the responsible conduct of research. Acad Med. 2007;82:838–845.
Kalichman MW, Plemmons DK. Reported goals for responsible conduct of research courses. Acad Med. 2007;82:846–852.
Kotzer AM, Milton J. An education initiative to increase staff knowledge of Institutional Review Board guidelines in the USA. Nurs Health Sci. 2007;9:103–106.
Redman BK, Templin TN, Merz JF. Research misconduct among clinical trial staff. Sci Eng Ethics. 2006;12:481–489.
Resnik DB, Dinse GE. Do U.S. research institutions meet or exceed federal mandates for instruction in responsible conduct of research? A national survey. Acad Med. 2012;87:1237–1242.
Steneck NH, Bulger RE. The history, purpose, and future of instruction in the responsible conduct of research. Acad Med. 2007;82:829–834.
Beresin EV, Baldessarini RJ, Alpert J, Rosenbaum J. Teaching ethics of psychopharmacology research in psychiatric residency training programs. Psychopharmacology (Berl). 2003;171:105–111.
Chen DT. Curricular approaches to research ethics training for psychiatric investigators. Psychopharmacology (Berl). 2003;171:112–119.
Hamrell MR. Raising suspicions with the Food and Drug Administration: detecting misconduct. Sci Eng Ethics. 2010;16:697–704.
Jha S. The nurturing of the clinical research coordinator. Acad Radiol. 2010;17:1325.
Larson EL, Cohn EG, Meyer DD, Boden-Albala B. Consent administrator training to reduce disparities in research participation. J Nurs Scholarsh. 2009;41:95–103.
Trembath L, Opanowski A. Clinical trials in molecular imaging: the importance of following the protocol. J Nucl Med Technol. 2011;39:63–69.
Vulcano DM. CPI certification as predictor of clinical investigators’ regulatory compliance. Drug Inf J. 2012;46:84–87.
Dolor RJ, Smith PC, Neale AV. Institutional review board training for community practices: advice from the Agency for Health Care Research and Quality Practice-Based Research Network listserv. J Am Board Fam Med. 2008;21:345–352.
Graham DG, Spano MS, Manning B. The IRB challenge for practice-based research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007;20:181–187.
Graham DG, Spano MS, Stewart TV, Staton EW, Meers A, Pace WD. Strategies for planning and launching PBRN research studies: a project of the Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007;20:220–228.
Hu X, Graesser AC. Human use regulatory affairs advisor (HURAA): learning about research ethics with intelligent learning modules. Behav Res Methods Instrum Comput. 2004;36:241–249.
Rosa C, Campbell A, Kleppinger C, Sampson R, Tyson C, Mamay-Gentilin S. Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience. Clin Trials. 2009;6:151–161.
Yawn BP, Graham DG, Bertram SL, et al. Practice-based research network studies and institutional review boards: two new issues. J Am Board Fam Med. 2009;22:453–460.
Anderson C, Young PA, Berenbaum A. Food and Drug Administration guidance: supervisory responsibilities of investigators. J Diabetes Sci Technol. 2011;5:433–438.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Investigator responsibilities—protecting the rights, safety and welfare of study subjects. 2009.
Koren M, Koski G, Reed D, et al. APCR physician investigator competence statement. The Monitor. 2011;25:79–82.
Schwetz BA. Protecting subjects without hampering research progress: guidance from the Office for Human Research Protections. Cleve Clin J Med. 2007;74(suppl 2):S60–S62; discussion S68-S69.
Barnes BE, Friedman CP, Rosenberg JL, Russell J, Beedle A, Levine AS. Creating an infrastructure for training in the responsible conduct of research: the University of Pittsburgh’s experience. Acad Med. 2006;81:119–127.
Braunschweiger P, Goodman KW. The CITI program: an international online resource for education in human subjects protection and the responsible conduct of research. Acad Med. 2007;82:861–864.
Merritt MW, Labrique AB, Katz J, Rashid M, West KP Jr., Pettit J. A field training guide for human subjects research ethics. PLoS Med. 2010;7.
Rivera R, Borasky D, Rice R, Carayon F. Many worlds, one ethic: design and development of a global research ethics training curriculum. Dev World Bioeth. 2005;5:169–175.
Collaborative Institutional Training Initiative (CITI). www.citiprogram.org. Accessed November 5, 2015.
Academy of Physicians in Clinical Research (APCR). www.apcrnet.org/default.aspx. Accessed November 5, 2015.
National Institute of Allergy and Infectious Diseases (NIAID). www.niaid.nih.gov/Pages/default.aspx. Accessed November 5, 2015.
TransCelerate. www.transceleratebiopharmainc.com/. Accessed November 5, 2015.
US Food and Drug Administration (FDA). Clinical Investigator Training Course. www.fda.gov/Training/ClinicalInvestigatorTrainingCourse/default.htm. Accessed November 5, 2015.
US Department of Health and Human Services. Food and Drug Administration. Statement of Investigator. Title 21, Code of Federal Regulations Part 312 (21CFR312.53). http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf. Accessed October 30, 2014.
Boston WE, Ice P, Gibson AM. Comprehensive assessment of student retention in online learning environments. Spring 2011. University of West Georgia, Distance Education Center. http://www.westga.edu/∼distance/ojdla/spring141/boston_ice_gibson141.html. Accessed October 27, 2014.
Gorrindo T, Chevalier L, Goldfarb E, Hoeppner BB, Birnbaum RJ. Autonomic arousal and learning in web-based simulation: a feasibility study. J Contin Educ Health Prof. 2014;34(suppl 1):S17–S22.
Schmidt KL, Yasko L, Green M, Alexander J, Ryan C. Evolution of an innovative approach to the delivery of in-person training in the responsible conduct of research. Clin Transl Sci. 2014;7:512–515.
Author information
Authors and Affiliations
Corresponding author
Additional information
Dr. Merchant is no longer affiliated with the Clinical Trials Transformation Initiative
Rights and permissions
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Arango, J., Chuck, T., Ellenberg, S.S. et al. Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency. Ther Innov Regul Sci 50, 480–486 (2016). https://doi.org/10.1177/2168479016635220
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479016635220