FDA Announces ICH E6(R2) Guidance
On 1 March 2018, the Food and Drug Administration (FDA) announced guidance for Good Clinical Practice (GCP), entitled "E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)." This guidance represents the current thinking of the FDA.
This integrated addendum guideline was collaboratively developed by the International Council for Harmonisation with input from the FDA. ICH E6(R2) "discusses approaches to clinical trial design, conduct, oversight, recording, and reporting as well as updated standards regarding electronic records and essential documents."
CITI Program GCP courses reflect the FDA updated guidance
CITI Program's GCP modules reflect that the FDA has published ICH E6(R2) as guidance. The modules were previously revised to reflect the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) updated guideline.
CITI Program has a free resource on the ICH E6(R2) integrated addendum.
This resource is available on CITI Program's Resources page. This resource was revised to reflect the FDA update guidance.
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.