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Good Clinical Practice

Good Clinical Practice Training

A new policy requires that NIH-funded investigators and staff involved in clinical trials complete training in Good Clinical Practice (GCP) and the principles of the International Conference on Harmonization (ICH). The policy goes into effect January 1, 2017.

Investigators and their staff may comply with this requirement by completing the GCP course offered by CITI. There are 14 required modules plus four optional ones and training is valid for three years.   After course expiration (3 years), investigators and their staff will need to repeat the basic course to renew. To access the CITI course see the instructions below.

Please note this training should meet the requirements for both campuses. Questions can be directed to ORSP. For additional information, please see NIH Notice NOT-OD-16-148: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

Instructions for accessing the CITI GCP course:

  1. Go to www.citiprogram.org.
  • If possible, use Firefox, Chrome, or Internet Explorer.
  • The Safari browser does not work as consistently
  1. New Users: Go to Create an Account select Register.

New users complete Registration Steps 1-7, click “submit”.

  • For Qu. 1, WFU is listed under “Participating Institutions”.  Be sure to select Wake Forest University, not WFU Health Sciences.
  • For Qu. 5 most users should not select CME/CEU credits.
  • For Qu. 7 select which courses to study
  • Courses: select Good Clinical Practices to study and submit.

Current Users: Log into Existing Account

  1. After registering, go to the Main Menu, select Wake Forest University Courses, then select Add a Course
  2. Under Getting Started, check Good Clinical Practice then click Next
  3. Under Wake Forest University Courses, select GCP for Clinical Trials with Investigational Drug and Biologics (ICH Focus)
  4. Select Complete the Integrity Assurance statement before beginning the course. Read the Assurance Statement.  To continue, check I Agree and Submit
  5. Begin the module(s).

For problems with the CITI GCP program, contact Pam Moser, in Office of Research and Sponsored Programs, at moserpc@nullwfu.edu.