Good Clinical Practice (GCP) is a unified standard developed in order to conduct ethical and scientifically sound research. The International Conference of Harmonization has developed guidance documents (ICH E6) to facilitate the acceptance of clinical data for international studies and to protect the rights, safety, and well being of trial subjects. The ICH took into consideration input from regulatory agencies around the world. As more clinical trials are being conducted on a global scale, Industry has adopted these guidelines as “best practice”. This had led to an increased demand for Investigators and Coordinators to be certified in Good Clinical Practice. While ICH GCP is being accepted as the “standard” for conducting clinical trials, the guidance does not supersede regulations set forth by the Food and Drug Administrations Code of Federal Regulations (CFR).
In order to facilitate GCP certification among members of the PRCSG, the Coordinating Center is providing a training program through the Collaborative Institutional Training Initiative (CITI).
1. Log on to www.citiprogram.org
2. Click on: Register
3. Enter “Greater Cincinnati Academic and Regional Health Centers” in Select Your Organization Affiliation. Submit
4. Complete user name, password, name and email address. Submit.
5. Complete star (*) fields. For Employee Number, enter LOVELL. Submit.
6. When completing your user profile, for the GCP course to be offered, you must answer “yes” to performing studies in drugs/biologics. Other courses will be offered that you can ignore.
7. Print out certificate and fax to the PRCSG Coordinating Center.