HRA GOOD CLINICAL PRACTICE (GCP) E6R2 TRAINING
COURSE REGISTRATION
Registration for both the live webinar and the pre-recorded on-demand courses is available in HealthStream. Search for “HRA Good Clinical Practice (GCP) E6R2 training”
These courses are not assigned to members of the MGB research community. Users will need to register for the course in HealthStream. Click here for flipbook instructions for How To Register For On-Demand Courses in HealthStream.Â
COURSE DESCRIPTION
The HRA Compliance and Education Office 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.
This course was 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.
COURSE FORMAT OPTIONS
- In-person, instructor led live webinar training – Eligible for RCR Credit!
- Pre-recorded course available on-demand
COURSE LENGTH
The course takes 1 ½ hours to complete.Â
*Recertification is required every 3 years from date of completion.
We do not manually update profiles in Insight. We receive course completion reports from HealthStream each weekday, and that report is uploaded to Insight each night, Monday-Friday. It takes two business days for the course completion information to be posted in Insight, which is the same as it was for CITI training.Â