Course Certificate
for
TITLE:
Introduction to GCP for Site Staff.
VERSION:
3.1, April 2018.
FORM:
E-Learning, duration approximately 60 minutes.
TARGET GROUP:
Health Professionals conducting commercial or non-commercial clinical trials with medicinal products.
OBJECTIVE:
To provide a general introduction to Good Clinical Practice (GCP) and the conduct of clinical trials in Denmark.
CONTENT:
The course covers the following topics:
- Introduction
- ICH-GCP, history, contents, and principles
- ICH-GCP, definitions
- Application of a clinical trial in Denmark
- Investigator’s Responsibilities
- Sponsor’s Responsibilities
Each topic starts with a description and is completed by a test.
I hereby confirm that I have completed this course.
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Signature
THIS COURSE IS DEVELOPED BY:
