CITI Program's GCP modules that reference ICH E6 were revised to reflect the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) updated guideline. GCP modules now specifically refer to the current ICH E6(R2) guideline.
Learners who completed all recommended modules in a GCP FDA or ICH course (both basic and refresher) after the version 2 effective date have completed the revised ICH E6(R2) training.
For example, the GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course reflected ICH E6(R2) on 20 January 2017 (the version 2 effective date for this course). If learners completed all recommended modules on 5 March 2017, then they completed version 2 and received ICH E6(R2) compliant training.
Review Version 2 Effective Dates
Note: The Good Clinical Practice (GCP) translated courses are in the process of being revised.
What if learners completed the course before the version 2 effective date?
Learners who completed any recommended modules in a GCP FDA or ICH course (both basic and refresher) before the version 2 effective date (before the course was updated) may re-complete the modules. This will update the Completion Report (the Transcript Report part) to show sponsors that the ICH E6(R2) training was completed.
Will Completion Reports show that learners completed version 2 of the course?
Yes, a course containing all of the modules and completed after the course's effective date for GCP mutual recognition will contain a statement in the Completion Report's Course Transcript description field that identifies:
This statement will also confirm that the learner has completed all the attested CITI Program modules from the course to meet the minimum criteria for ICH GCP training identified by TransCelerate BioPharma.
For more information visit Reading and Understanding a CITI Program Completion Report for Good Clinical Practice (GCP) TransCelerate BioPharma Mutually Recognized Training.
Does the CITI Program offer any ICH E6(R2) specific courses or modules?
No, the CITI Program does not offer specific ICH E6(R2) courses or modules. The revisions to this guideline were integrated into the GCP courses.
However, the 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 of the changes by section with summaries and analysis. The revised ICH E6(R2) guideline includes changes that affect sponsors, investigators, and IRBs.