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MGB HRA Education: Good Clinical Practice (GCP)
March 15 @ 12:00 pm - 1:30 pm
This Good Clinical Practice Webinar course was developed based on the original content of the International Council of Harmonization’s Guidance for Good Clinical Practice (GCP) ICH GCP E6R2, current step 4 version dated 9 November 2016. It is intended to provide researchers with training that applies GCP principles to all types of research. GCP is the international ethical and scientific standard for designing, conducting, recording, and reporting human research trials in a way that assures the protection of our participant’s rights, safety and well-being and ensures our clinical trial data are credible and verifiable.
Sample of Topics:
- Review principles and regulatory requirements for Good Clinical Practice (GCP)
- Outline the goals of GCP
- Provide a historical perspective on GCP
- Discuss roles and responsibilities of the Principal Investigator and study’s staff, protocol compliance, and other criteria for conducting clinical trials.
- Common findings/observations
- Describe best practices for GCP compliance
- Andrea Morris – Assistant Director of Education, MGB Human Research Affairs Compliance & Education Office
- The Good Clinical Practice (GCP) training will be offered monthly through the MGB Human Research Affairs Compliance & Education Office. Future dates can be found here.
**This session will be held virtually. The link will be sent to those who register with a BWH/MGB-affiliated email address ~1 day prior to the session**