Comprehensive GCP Training to Meet Your Needs (Aug 2017)

CITI Program offers an array of GCP courses for research with drugs, biologics, devices, and behavioral interventions and social science research.
CITI Program offers GCP courses that are:

  • Up to date with ICH E6(R2) revisions
  • Mutually recognized by sponsors
  • National Institutes of Health (NIH) acceptable
  • Tailored to behavioral interventions and social science research

Up to Date with ICH E6(R2) Addendum

CITI Program's GCP modules that reference the ICH E6 guideline were revised to reflect the updated ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). GCP modules now specifically refer to the current ICH E6(R2) guideline and provide ICH E6(R2) training.

Mutually Recognized by Sponsors

Ten of CITI Program's GCP courses meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Study monitors or site administrators can confirm that a learner has completed one of these recognized courses by reviewing the description field on the Transcript Report of the learner’s Completion Report. Mutually recognized GCP courses containing all of the modules and completed after the course's effective date for mutual recognition will contain a statement in the description field that identifies the course name and version number (version 2 indicates the course included ICH E6[R2] addendum). See the effective dates for ICH E6(R2) training and view an example Transcript Report.

Acceptable for NIH GCP Policy

On 16 September 2016, the NIH issued a new policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that says NIH-funded investigators and staff should be trained in GCP.  CITI Program's GCP training is compliant with this policy.  See Q&A: GCP Training and the new NIH Policy for more details and a list of acceptable courses for GCP training.

GCP for Behavioral Interventions and Social Science Research

CITI Program now offers the NIH-developed GCP - Social and Behavioral Research Best Practices for Clinical Research course. This course introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research. It is presented in a dynamic, nine-module format with narration, interactive features, and downloadable resources. 

Return to August 2017 Newsletter
Last Updated: 09-Jan-2019 11:24 a.m. EST
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