Good Clinical Practice (GCP) Certification

Good Clinical Practice Certification tracks the completion of a Good Clinical Practice training course every three years within Workday Learning.

Per WashU’s Good Clinical Practice Policy educational requirement, there are three GCP training options:

• Complete a CITI GCP course online: available on-demand
• Complete an NIH GCP course online: available on-demand
• Attend a WashU-sponsored instructor-led course: The OVCR offers sessions each year in the spring and fall. When the next sessions are scheduled, you can find them in the OVCR events calendar.

How to Enroll

Only ONE course is required to satisfy WashU’s GCP training requirements. Click on one of these three options:

• Good Clinical Practice (GCP) CITI Training
  • Follow the links in the course description to log into the CITI Program and access the training.
  • Your successful completion of a course will automatically transfer from CITI to Workday Learning in an overnight process.
• Good Clinical Practice (GCP) NIH Training
  • Follow the links in the course description to access the NIH GCP Training Options page.
  • Your certificate of completion must be emailed to ovcrinfo@wustl.edu to be manually marked complete in Workday Learning.
• Good Clinical Practice (GCP) Instructor-Led Training
  • If courses are available, select your desired date to enroll. If you see a greyed-out button for “No Offerings Available,” this means no courses are currently scheduled. The OVCR typically schedules instructor-led courses in the spring and fall.
  • Your certificate of completion will be available in Workday Learning within 1-2 business days. See instructions below to obtain a certificate.

ICH GCP E6 (R3) Requirement

WashU’s GCP Training Policy currently requires R2, not R3 training. If your sponsor requires ICH GCP E6 (R3) compliant training, you should complete one of the following courses:

CITI Courses

• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • This course is R3 compliant as of 23-JULY-2025.
• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • This course is R3 compliant as of 15-OCTOBER-2025.

NIH Courses

• National Institutes on Drug Abuse (NIDA) GCP Training Course
  • This course is R3 compliant as of 1-APRIL-2026.

Frequently Asked Questions

How do I complete Learn@Work GCP training?

Access the GCP Certification in Workday Learning and complete one of the GCP trainings.

How do I print my certificate?

Certificates are available through the organization from which you took training.

• If you complete CITI training, print your certificate through CITI. See the CITI Quick Guide for instructions.
• If you complete NIH training, print your certificate through the NIH institute from which you completed the training.
• If you attended a WashU-sponsored instructor-led course, follow the Generate Certificate of Completion instructions. Search for the course “Good Clinical Practice (GCP) Instructor-Led Training.”
• If you need a copy of your previously completed ACRP GCP training certificate, please email ocvrinfo@wustl.edu.

What topics are covered in the in-person WUSTL-sponsored instructor-led GCP training course?

This course complies with the expectations set by the NIH’s National Center for Advancing Translational Sciences (NCATS) for GCP training for CTSA Consortium Hubs and meets the minimum criteria for International Council on Harmonization (ICH) GCP E6, R1 and R2 training including: GCP Overview and Definitions, the Principles of ICH GCP, IRB/Investigator/and Sponsor Responsibilities, Clinical Trail Protocol and Protocol Amendments, Investigator Brochure and Essential Documents for the Conduct of Clinical Trials.

Do I have to complete GCP training if I am involved with a behavioral trial?
Yes. Clinical trials include behavioral studies. All research team members of a behavioral trial must complete GCP training.

How often do I have to complete GCP training?
GCP training must be completed at minimum every three years. Your sponsor may require training more frequently.

What should I do if my sponsor requires GCP training more frequently than three years?
PIs are responsible for completing and tracking any required annual trainings. For satisfying the sponsor-specific GCP re-certification requirements and/or the University’s GCP re-certification/refresher requirement, clinical investigators and clinical research staff may attend GCP training programs offered by sponsors (e.g., through study-specific site initiation visits or other types of in-person training mechanisms offered by the sponsors) or the University. PIs or their departments may track the completion of these programs using Excel spreadsheets and include the title of the program, program faculty name and credentials, and the date of the program. They may also keep copies of any certificates obtained from these programs. They may be asked to produce this document in audits, reviews, or other requests for information.

Is this the same as CITI Human Subjects training?
No. GCP training is different than, and does not replace, CITI Human Subjects training.

Who should I contact with questions?
Email hrqa@wustl.edu​ with questions concerning the Education in Good Clinical Practice Policy.