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Good Clinical Practice (GCP) Training and ICH GCP E6 (R3) Requirements

Researchers who have completed the GCP training through CITI and remain current are considered compliant by the institution. Researchers will receive a notification as their GCP training nears expiration and the refresher is due. The required refresher will include ICH GCP E6 (R3) at no additional cost.

If a Sponsor or other external party requires ICH GCP E6 (R3) training before current GCP certification expires, the CITI ICH GCP E6 (R3) refresher will include a fee. In these situations, researchers are encouraged to work directly with the Sponsor or requesting party to clarify requirements and determine responsibility for training costs.

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Forms & Templates FAQs Non-OHSU Research Collaborators Working with Other IRBs - General Waived Study Process IRB Fee Policy Research Training Requirements

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Study-Specific Questions
Please contact the IRB Coordinator on the Study, Modification, or Continuing review via “Contact IRB Team – Ancillaries – Study Team” feature


General IRB Questions
irb@ohsu.edu


General Reliance or Waived Study Questions
irbreliance@ohsu.edu