The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.
GCP training aims to ensure that:
- the rights, safety, and well-being of human subjects are protected
- clinical trials are conducted in accordance with approved plans with rigor and integrity
- data derived from clinical trials are reliable
View each video to learn more about different topics in GCP. To pass this course, you must complete the assessment with a score of 80% or greater.
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.
- What is GCP?
- Core Principles
- Sponsor's Role and Responsibilities
- Investigator's Role and Responsibilities
- Informed Consent
- Safety Reporting
- Investigational Product Management
- Essential Documents
By completing/passing this course, you will attain the certificate Advarra ICH GCP Completion Certificate
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