Toward Greater Scientific Rigor
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- Scott Benson
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1 Toward Greater Scientific Rigor Good Clinical Practice (GCP) A NEW REQUIREMENT! The Center for Clinical & Translational Science ccts@uab.edu
2 The requirement: NIH: NOT-OD Policy of Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials
3 New initiatives to ensure rigor and efficiency in clinical trials Re-engineer DESIGN: the process by which clinical investigators develop ideas for new trials, CONDUCT: how NIH reviews and selects clinical trials for support and oversees the progress of the research, and REPORTING: how results and aggregate data are shared broadly and rapidly.
4 RIGOR: Requiring GCP training GCPs provide a consistent and high quality standard for conducting research. All NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonization (ICH) E6 (R2). The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCPs provide a standard for ensuring Describes clinical trial compliance, implementation, data collection, monitoring, and reporting Outlines the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. Addresses elements related to the design, conduct and reporting of clinical trials.
5 BUT what are GCPs? Simply put, they provide guidelines: to assure the rights of study subjects are protected in research. to assure the accurate and reliable collection of data in research.
6 International Conference on Harmonization Good Clinical Practices The principles were developed in 1996 with representatives from the European Union, Japan, and the United States. Describes the responsibilities of investigators, sponsors, monitors and IRBs. NOT the same as IRB training (which became a requirement in June 2000.
7 What NOT-OD says: Scope and Applicability This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. GCP training includes the Principles of ICH GCP found in Section 2 of ICH E6. GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Investigator: The individual responsible for the conduct of the clinical trial at a trial site. Clinical trial staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements.
8 (ICH) E6 (R2) pending updates. Pending changes implemented to ICH GCP E6 (R2) in 2016: Oversight: increased requirement for investigators when third party involved, and more sponsor oversight of CRO/monitor. Technology: Data security (mirrors 21 CFR 11). Significant non-compliance: CAPA correction and preventive action. Risk Management: requiring quality management system and Risk Based Monitoring.
9 SOOO where is the training and how will we know we are compliant? Basic course: Miami CITI ICH-GCP training Enhanced courses: Research Orientation Program (monthly everyone) Research Coordinator Training Program (twice a year staff) Clinical Investigator Training Program (in development) Research Seminar (2 offerings monthly) Others to come
10 Requiring GCP training is a first step While GCP training on its own may not be sufficient, it provides consistent and high quality standards which should be followed. Release date: 16 September 2016 Effective date: 1 January 2017
11 I am not doing NIH funded Clinical Trials, so why do I need to do this? ALL human research, whether locally funded or industry sponsored, ethically require that the same standards: Provide guidelines to assure the rights of study subjects are protected in research. Provide guidelines to assure the accurate and reliable collection of data in research.
12 Top 10 GCP issues on FDA 483s (FDA warning letter) CFR Reference Frequency Description #1 21 CFR (d) 169 Procedures not in writing, fully followed #2 21 CFR Investigations of discrepancies, failures #3 21 CFR (a) 116 Absence of Written Procedures #4 21 CFR (b) 115 Scientifically sound laboratory controls #5 21 CFR (a) 89 Control procedures to monitor and validate performance #6 21 CFR (b) 73 Written procedures not established/followed #7 21 CFR (a) 69 Calibration/Inspection/Checking not done #8 21 CFR (a) 65 Training operations, GMPs, written procedures #9 21 CFR (a) 65 Cleaning / Sanitizing / Maintenance #10 21 CFR (b) 64 SOPs not followed / documented
13 Questions? th Ave. S UAB Campus - PCAMS Thank you to our Partners! The Center for Clinical & Translational Science ccts@uab.edu
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