Good Clinical Practice at Stanford
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Spectrum Operations, Training and Compliance (OTC) serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.
Services Provided
- Budget & Billing Support
- Regulatory/Compliance Support
- Study Facilitators
- Training & Education
- Point of Contact for questions about clinical research
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Contact Information
Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
(650) 498-6498
Fax (650) 723-8552
Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.
Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.
Useful Links
- ICH E6: Good Clinical Practice: Consolidated Guidance
- FDA Office of Good Clinical Practice
- FDA Clinical Trials
- International Conference of Harmonization (at FDA)
Education and Training
Stanford Courses
- Collaborative IRB Training Initiative (CITI)
The CITI trainings offered through the Research Compliance Office include modules in good clinical practice. These modules offer a general overview and are free of charge. - For more information about CITI training, see the Research Compliance Office website.
- Good Clinical Practice Fundamentals Course
This one-day course is designed for new clinical research coordinators, nurses and administrative staff, who have limited experience with and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor. Emphasis is placed on the translation of GCP principles to the concepts of protocol adherence, informed consent process, good documentation practices, event reporting, and proactive preparation for FDA/Regulatory audits. Interactive exercises and case scenarios facilitate the application of these principles into everyday practice governing the conduct of clinical trials. - GCP Beyond the Basics
For more experienced research coordinators, nurses and staff who are already familiar with basic GCP principles and are looking for more detail in areas of interest, four--hour sessions offer expanded instruction in selected GCP areas such as adverse event reporting, informed consent, and audit readiness. - GCP Brown Bags
The Good Clinical Practice (GCP) Brown Bag sessions are informal monthly meetings open to anyone in the Stanford research community. Brown Bags offer a chance to meet people outside your department, to discuss topics of interest, ask questions and exchange solutions to common challenges. Past sessions have included discussions on working with non-English speakers, consenting participants over the phone and via mail, drug accountability, good documentation, recruitment, research with devices, and more. - Meetings occur on the fourth Thursday of each month from 11:30 – 12:30pm. View the Spectrum Education Calendar for details and topics.
Next Steps
- Chat on CAP
Ask a question or discuss topics of interest, join the GCP Brown Bags group. Login, click Groups, enter GCP Brown Bags, and join. - View Training Calendar
Register for current and upcoming training. - GCP Brown Bag Wiki
Accessible only to those who have attended a GCP Brown Bag or Course at Stanford. View GCP Brown Bag schedule and best practices, information about upcoming GCP One-day and Beyond the Basics courses.