In June, 2007, UW Medicine launched a new Web-based GCP training program through the Collaborative Institutional Training Initiative (CITI) at the University of Miami. The CITI GCP course replaces the GCP course formerly offered by Clinfosource. UW Medicine will continue to recognize course credit that was obtained through the Clinfosource program.
What is GCP?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that involve human subjects. Compliance with GCP provides assurance that the data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial subjects are protected.
GCP is not one set of safety standards, issued by one regulatory agency, or found in one document. Rather, the GCP standard evolved over time, is recognized by regulatory agencies around the world, and includes the procedures by which drugs and devices are approved for human use. GCP standards are recognized by the Office for Human Research Protections (OHRP) and included in the Food and Drug Administration (FDA) guidance document for clinical trials.
Who hosts the Web-based training program?
GCP training is available through the Collaborative Institutional Training Initiative (CITI) at the University of Miami. The new GCP course is available at no cost to faculty, students, trainees, and staff at the University of Washington through self-registration on the CITI site. The course is hosted on secure servers at the University of Miami. The CITI office at the University of Miami retains all records in strict confidence.
Is GCP training required?
GCP training is not presently required by UW Medicine. Nevertheless, GCP training is recommended for those involved in clinical trials. Pharmaceutical companies and other research sponsors may monitor investigator compliance with GCP and some require GCP certification for participation of investigators and their staff in sponsored trials.
Is GCP course credit available?
Professional credit is available through the University of Miami Continuing Medical Education. After completing each module and scoring at lest 75% on each test, users can download a course “Completion Report” that can be used to document completion of the program for all disciplines. Detailed information about obtaining credit is available through the “CME/CEU” link at the bottom of each CITI Web page.
Note that although you may decide to take this GCP course for credit, it is also continuously available as a free reference.
How do I access the GCP training course?
1. Go to the CITI registration page at https://www.citiprogram.org/
2. Select “New Users Register Here.”
3. From the drop-down menu of participating institutions, select “University of Washington.”
4. Enter and submit your name and email address.
5. Complete the “Member Information” questionnaire.
6. Read the UW Introductory page and select “Good Clinical Practice (GCP) Course.”
7. Read the modules and take the tests. NOTE: Only by taking the tests will you be able to access the next module on the list.
8. VERY IMPORTANT: Print or save the completion report when finished!