Quick Help

Gigi Streidl
Clinical Trials Administrative Manager
Office of Clinical Research
(206) 616-8289
restudy@u.washington.edu

Good Clinical Practice

Good Clinical Practice is a set of internationally recognized standards for subject protection and data integrity in clinical trials.

Standard Operating Procedure Templates GCP guidelines recommend that investigative sites and study sponsors maintain a set of current Standard Operating Procedures (SOPs). UW School of Medicine faculty and staff may obtain a license for a set of SOP templates developed by the Center for Clinical Research Practice. Once licensed, the templates should be adapted to reflect each research facility's practices. The templates are available in two versions: a set for Investigative Sites (Second Edition, 2001, $135) and a set for Sponsors (First Edition, 1999, $125). The Standard Operating Procedures Electronic Template (SOPET) software requires Microsoft Windows and Word 97 or higher.

If you hold an IND, you are both the investigator and the sponsor.

• GCP SOP Templates for Investigative Sites — Table of Contents, sample SOP and Licensing information
• GCP SOP Templates for Sponsors — Table of Contents and Licensing information

GCP Training and Certification The Office of Clinical Research offers a free web-based GCP training program that carries both Continuing Medical Education (CME) and Continuing Nursing Education (CNE) accreditation. At the GCRC, we highly recommend this course for documentation and training of your clinical research team.

Links

• GCP Links