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GCP - CITI Program
CITI is an online learning platform that offers courses in research, ethics, compliance, and safety. To get access to the CITI Program you must register on the site or associate your existing registration with Simon Fraser University. Note that access to these courses has been provided by Clinical Trials BC, who have funded and managed these courses since 2017.
For information on accessing the platform, please visit the CITI Program page.
Good Clinical Practice (GCP) sets the standard for the design, conduct, monitoring, and reporting of clinical research. Compliance with GCP standards assures not only that human participants will be adequately protected but also that the data submitted to regulators with the applications to market investigational products are accurate and credible.
This course looks at the history and evolution of GCP, including sponsor responsibilities, informed consent in clinical trials and monitoring clinical trials.
What you'll learn
- Audits and Inspections of Clinical Trials
- Overview of ICH GCP
- Institutional Review Board/Independent Ethics Committee/Research Ethics Board (IRB/IEC/REB)
- Sponsor Responsibilities and GCP
- Managing Investigational Products According to GCP Requirements
- Informed Consent in Clinical Trials of Drugs and Biologics
- Detection, Evaluation, and Reporting of Adverse, and Serious Adverse Events
- Administrative Documents
- Monitoring Clinical Trials by Sponsors
Who this course is for
All Research Faculty & Staff
Method
Self-serve, self-enrolment
Estimated time to complete
schedule 9 modules approx 30 mins each