Description
This course covers the guidelines for assessing the safety and well-being of study participants set in accordance with Good Clinical Practice (GCP).
Attendance at this program has been approved for 0.50 contact hours of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 0.50 hours of CE credit.
Objectives
By the end of this course, learners will be able to:
- Define and identify adverse events in a trial
- Understand why and how to document and communicate adverse events
- Determine whether it is safe for a participant to continue in a study after experiencing an adverse event
- Respond to an outside safety report (OSR)
Certificate
By completing/passing this course, you will attain the certificate zzzz Advarra Completion Certificate (No Expire)
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