GCP ICH E6(R2) Integrated Addendum

September 28, 2017

At this time, DF/HCC does not require separate training on the GCP ICH E6(R2) Addendum.

However, some sponsors are requiring training, so we'd like to provide a couple of options for fulfilling this requirement:

Two ways to complete training on the addendum:

(1) CITI GCP Training (Basic or Refresher) - The addendum went into effect on December 15th, 2016. At that time, the addendum was incorporated into an updated GCP training in CITI. Anybody who has taken the CITI GCP training after December 15th, 2016 has already been trained on the addendum, and may use their training certificate as proof of training.

See here for more information from CITI: about.citiprogram.org/en/news/updated-gcp-modules-ich-e6-r2/

Instruction on completing GCP through CITI can be found on the ODQ Education Page.

(2) CITI Overview Slides - CITI has also provided slides to review the changes the addendum encompasses.

The slides may be viewed here: about.citiprogram.org/wp-content/uploads/2017/08/GCP-ICH-Revisions-Resource.pdf

To document training on these slides, please contact your institution's clinical trials office for more information.

 

Please visit the ODQ Education page for more information on GCP training, or contact ODQEducation@dfci.harvard.edu with additional questions!