Introduction to Good Clinical Practice
This introductory course to Good Clinical Practices(GCP) will take you directly into the fundamental elements and objectives of GCP to illustrate why and how these are enforced throughout every stage of a clinical investigation.
You will also be introduced to the major requirements outlined within the Declaration of Helsinki and be pointed to the applicable documents laying out the rules of medical device good clinical practices as per ISO 14155, 21 CFR part 812, 50 and 56 and Japanese ICH for medical devices.
Upon completion of this course, trainees will be able to correctly and successfully:
- Define the basic elements and objectives that compose Good Clinical Practice.
- Comprehend in detail the requirements as outlined in the Declaration of Helsinki.
- Understand which rules and regulations stipulate GCP requirements worldwide.
Monitors/clinical research associates, clinical investigators, study coordinators.
Quality assurance, regulatory, sales and marketing professionals, wanting to understand the basic requirements of Good Clinical Practice.
Understanding the history of Good Clinical Practice is an advantage before taking this course.