Administratively Revised 4/30/2019
Washington University Education in Good Clinical Practices
Washington University in St. Louis is committed to assuring the safety, integrity and quality of clinical trials as part of its mission to foster excellence in research and to further advances in human health.
Education in Good Clinical Practice (GCP) principles is a natural outcome of that commitment because GCP programs provide training in the:
- Responsibilities of investigators, sponsors, monitors and IRBs
- Protections for the rights, safety and well-being of human subjects
- Conduct of the clinical trial in accordance with approved plans with rigor and integrity
- Generation of reliable data
- Standards for designing, conducting, recording and reporting trials involving human participates
Faculty and staff involved in the conduct, oversight or management of clinical trials must complete training in GCP if they meet the criteria outlined in the following Applicability section. Please be aware that specific sponsor, regulatory agencies or school/department requirements may also be applicable. In these cases, it is the responsibility of the PI and research team members to complete any additional training requirements. Demonstrated completion must be documented prior to submission of an IRB application that meets the following Washington University definition of a clinical trial. Completion of this education program complies with the NIH “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.”
III. Definition of a Clinical Trial
Washington University, for purposes of this policy, has adopted the NIH definition of a clinical trial: “A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
Again, it may be important for faculty and staff to recognize that other sponsors or regulatory agencies (e.g., FDA) may impose additional requirements which are the responsibility of the PI to meet.
All research team members including faculty, staff, students or other personnel listed on an IRB application for research meeting the definition of a clinical trial must comply with the requirements of this policy. The IRB definition of a research team member may be found at https://hrpo.wustl.edu/faq/what-does-engaged-in-research-mean. This policy applies to all clinical trials regardless of support including, but not limited to all NIH, other federal, industry, foundation and departmental sponsored clinical trials.
In addition to those required under this WUSTL policy, any member of the research team may be asked to complete GCP training as a result of a requirement of the following:
- Specific Sponsor or Regulatory requirement
- WUSTL IRB, independent (commercial) IRB or single/central IRB (sIRB) overseeing the project
- OVCR, Dean or department
V. Educational Requirements
Washington University provides a number of ways to complete this educational requirement, all of which must be registered and tracked in Learn@Work via the Good Clinical Practice Certification.
As of October 16, 2017, the available options are:
- Complete a CITI GCP course online
- Complete an NIH GCP course online
- Attend a 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 Trial Protocol and Protocol Amendments, Investigator Brochure and Essential Documents for the Conduct of Clinical Trials.
Download the Registering for GCP Certification Quick Guide [PDF].
Note that most prior completions of a CITI, NIH, or ACRP course (including test-out courses) will satisfy this educational requirement. If you have completed a CITI or ACRP course in Learn@Work prior to October 16, 2017, these should be automatically marked complete. If you have previously completed an NIH GCP course outside of Learn@Work, email your certificate to firstname.lastname@example.org.
For those individuals covered by this policy, training must be completed and documented prior to IRB submission. The Office of Sponsored Research Services will use the IRB approval to establish new accounts in the general ledger for the applicable clinical trial agreements.
This policy on GCP training does not replace the Human Subjects Education Policy which provides education in the protection of human participants and the ethical conduct of research.
Compliance with this policy is required for all applicable projects and individuals beginning with the effective date.
Refresher training is required at least every three years.
Some sponsors may require annual refresher training. It is the responsibility of the PI and research team member to understand these specific sponsor requirements as described in their grant, subaward, clinical trial agreement or other documents and to assure completion and appropriate documentation of this requirement.
VII. Effective Date
The NIH policy requiring GCP training is effective January 1, 2017, and applies to all active NIH grants and contracts (at any stage in the grant/contract cycle). For all other clinical trials, the effective date is the approval date of this policy.
Frequently Asked Questions
Please see the GCP Frequently Asked Questions (FAQ) page.