GCP E6 Release 2 Bridge Course
Good Clinical Practice Bridge course for 2017 GCP Compliance
In the first update to Good Clinical Practice E6 since 1996, Release 2 introduced 26 major additions to the gold standard for the conduct of clinical research. These changes were introduced as an Integrated Addendum. This means there has been no change to the existing GCP E6, only integration of 26 new guidance’s.
GCP E6 Release 2 was crafted in response to the increasing use of technology in clinical trial design, conduct and reporting. In addition to the modernization of the guideline, release 2 integrates guidance in response to over 20 years of global regulatory / GCP audit findings.
This course introduces all of the changes put forth in release 2 and presents impacts for sponsors, sites and CROs.
This course has been designed to provide comprehensive, performance based content blended with real world applications. After reviewing the comprehensive content, students will use scenario based learning to apply these skills and ensure retention of the content.
Certificates of completion and comprehension will be issued after each student has completed the module assessments and final course comprehension test. These should be retained and presented as evidence of training on these revolutionary updates to the way we conduct clinical research.
Good Clinical Practice E6 Release 2 was finalized in November 2016 with Implementation in 2017.
The following modules are contained in this course:
- Good Clinical Practice E6 Release Development
- Glossary Updates
- 13 Principles Updates
- Investigator Oversight Updates
- Records and Reports
- Quality Management in Good Clinical Practice
- Monitoring Updates
- Sponsor Oversight
- Electronic Data
- Root Cause Analysis and Corrective Action - Preventative Action
- Essential Document Updates
Each and every addition to GCP E6 is addressed in this course including impacts for sponsors, CROs and clinical trial sites / investigators.
Estimated time to complete content and assessments: 2 Hours
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