In response to a growing interest in the Good Clinical Practice (GCP) Refresher course, the Program for the Protection of Human Subjects (PPHS) has now made a refresher course available via the CITI program for Icahn School of Medicine at Mount Sinai. Although there has been no change in institutional requirements, the PPHS wanted to make it easier for those who work on studies with external sponsors who require completion of a GCP Refresher every three years to conveniently get it.
What you need to know:
- The GCP basic course name has been updated to GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), which is the necessary precursor for the GCP Refresher.
- All credits transferred from the GCP course, so no one lost any credits due to this change.
- The GCP course now indicates that it expires every three years, enabling one to take the GCP Refresher course to comply with sponsor requirements.
- The PPHS office is not mandating this additional course (the refresher).
If you completed the GCP course over three years ago, when you log in to https://www.citiprogram.org/ your main page will indicate that you have incomplete coursework. If your sponsor requires a refresher every three years you can access it here. If your sponsor does not require the Refresher course, you can confirm your training status by clicking “View Previously Completed Coursework” under “My Learner Tools for Icahn School of Medicine at Mount Sinai.” You will be directed to a screen that includes the Basic Course. By clicking on “View” in the “Completion Report” column, you can print or save proof of your completion.
If you have any questions about this new resource or PPHS training requirements, contact the PPHS at firstname.lastname@example.org.