On 15 December 2016, the International Council for Harmonisation (ICH) adopted the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), which reflects the evolving modernization of research (such as, increases in globalization, study complexity, and technological capabilities of clinical trials). Researchers, sponsors, and IRB members who comply with ICH E6 should be aware of the new guideline.
CITI Program GCP courses reflect the changes from ICH GCP E6(R2)
After the ICH GCP E6(R2) guideline was adopted, CITI Program’s GCP modules that reference ICH E6 were revised to reflect the updated guideline. These GCP modules now specifically refer to the current guideline.
CITI Program has updated all affected GCP Modules in the following courses:
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- GCP FDA Refresher
- GCP ICH Refresher
CITI Program developed an overview of the ICH E6(R2) integrated addendum as a resource to the research community. It is available on the CITI Program’s Resources page.
This resource covers the revisions to the “International Council for Harmonistion (ICH) “Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2),” including a breakdown by sections with summaries and analysis. The revised ICH E6(R2) guideline includes changes that affect sponsors, researchers, and IRBs.