The Good Clinical Practice Certification is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational (not approved by FDA) drugs or devices. This Certification is valid for three years, and can be earned by successfully completing one of the following options in Learn@Work:
- Complete a CITI GCP course online
- Complete an NIH GCP course online
- Attend a WUSTL-sponsored instructor-led course
Download the Registering for GCP Certification Quick Guide [PDF].
Frequently Asked Questions
How do I complete Learn@Work GCP training?
Access the GCP Certification in Learn@Work and complete one of the GCP trainings.
For more information, reference the Registering for GCP Certification Quick Guide [PDF].
How do I print my certificate?
Certificates are available through the organization from which you took training.
- If you completed CITI GCP training, print your certificate through CITI. See the CITI Quick Guide for instructions.
- If you completed NIH GCP training, print your certificate through the NIH institute form which you completed the training.
- If you attended a WUSTL-sponsored instructor-led course, go to your ME page in Learn@Work and click Completed Learning in the left-hand menu. Locate the course you attended (not the certification), click the drop-down arrow on the far right, and click Print Certificate.
- If you need a copy of your previously completed ACRP GCP training certificate, please e-mail 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.