For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E-6 Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on sponsors/CROs and investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar reviews the proposed changes, the varied, select, clinical research practices impacted and select approaches to use when addressing the new requirements (e.g., standards, processes, procedures, training, documentation) that serve both as the starting point for an organization’s gap analysis, and, the subsequent re-design of work practices for compliance with the ICH GCP E6 R2 proposed revisions. In addition, an overview of key points to include in an organization’s project plan/implementation plan for the proposed revisions will be presented with time allocated for Q & A and discussion.
BONUS reference slides are provided on: Organizational quality management systems, quality, quality in the clinical trial context, risk definition, risk management framework benchmark (ISO 31000 model), and a list of industry think tanks that provide free information, training materials, methods and tools for the industry’s use since, due to time limitations, these topics are not able to be addressed. Barnett does provide training on these topics as distinct courses that are provided on-site or via web seminar that allows for a confidential discussion on your specific needs during the training.
- Identify two reasons (influencing factors) for the proposed revisions
- Identify three changes impacting investigator and sponsor responsibilities when compared to the current ICH GCP E6 Guideline
- List three gap analysis areas/topics and proposed approaches for promoting compliance with the proposed revision
- Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management
- Study Managers and Monitors (Centralized, On-site)
- Clinical Research Associates and Project Managers
- Quality Assurance Personnel
- Sponsor-Investigator IND Holder, Institution IND Holder
- Directors: Clinical Trial Unit, Clinical Trial Offices
- Office of Research Compliance and Risk Management Personnel
Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT
Click here for complete trainer biographies
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-16-051-L01-P. Released: 7/16.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.