This Good Clinical Practice certification course is intended to provide basic knowledge about the Guideline for Good Clinical Practice (GCP) E6 (R2) as adopted by the International Council for Harmonisation (ICH).
The course is suitable for clinical investigators, research staff, employees of biotech companies as well for people seeking a career in the field of clinical research with human participants.
At the end of the training course, there will be a test and a Certificate will be issued if at least 80% of the test questions are answered correctly.
ICH GCP Introduction: “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”
What Will You Learn?
- The rights of study participants and the safeguards to ensure their safety and well-being
- The requirements for obtaining informed consent from the study participants
- The principles of ICH GCP
- The responsibilities of the investigator
- The safety reporting requirements
Training ICH GCP Rev 2 – Version 1.0 – 01Oct2022