MGB HRA Education: Good Clinical Practice (GCP)

CLICK HERE TO REGISTER via HealthStream

Summary:

This MGB Human Research Affairs (HRA) International Council of Harmonization (ICH) Good Clinical Practice (GCP) course complies with the expectations set by the NIH National Center for Advancing Translational Sciences for GCP training and meets the minimum criteria for ICH GCP E6 R1 and R2. The 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. The content provides learners with the international ethical and scientific standard for designing, conducting, recording, and reporting human research trials to assure the protection of subject’s rights, safety and well-being and ensures clinical trial data are credible and verifiable. This training follows the ICH GCP E6R2 guidance and focuses on the 13 principles and roles and responsibilities of the IRB/IEC, Investigators and Sponsors.

This training is required for all involved in MGB/BWH Human Subjects Research. Read more here.

Important Notes to Receive Credit:

• Users taking this live (“webinar”) training are required to stay for the entire course duration and complete a knowledge check to receive credit.

— Attendance is tracked through Zoom and cross-referenced with registration in HealthStream. If users do not meet attendance requirements, then they will not receive a Certificate of Completion in HealthStream.

— Re-certification may be required by MGB HRA IRB or the MGB HRA Compliance & Education office.

• This live (“webinar”) training is worth 1 RCR credit-hour toward Part 2 of the MGB RCR Requirements. You will have to stay for the entire training and complete the knowledge check to receive credit, as detailed above. The recorded (“on-demand”) version is not eligible for RCR credit.

Future Dates/Recorded Version:

• The live (“webinar”) version of this training will be offered 2x/year through the MGB Human Research Affairs (HRA) Compliance & Education Office.

— Future dates can be found on HealthStream or on our Brigham calendar.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.

• The recorded (“on-demand”) version of this training is continuously available.

— The recorded (“on-demand”) version can be found on HealthStream.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.

CLICK HERE TO REGISTER via HealthStream