Good Clinical Practice ICH | 70 Questions with 100% Correct Answers | Updated & Verified
What is Good Clinical Practice (GCP)? - An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? - 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 is the objective Good Clinical Practice Guideline? - To provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice Guideline was developed by? - European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO)
Document information
- Uploaded on
- July 17, 2023
- Number of pages
- 14
- Written in
- 2022/2023
- Type
- Exam (elaborations)
- Contains
- Questions & answers