Kurztext

Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights.

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape.

Contents:
1. Introduction
2. Regulatory Requirements
3. Informed consent
4. Investigator responsibilities
5. Sponsor responsibilities
6. Clinical trial design
7. Site monitoring
8. Institutional Review Boards and Independent Ethics Committees
9. Pharmacovigilance
10. Clinical trial registration and reporting
11. Quality Assurence
12. Future implications of good clinical practices

256 p.
soft cover

Deutscher Apotheker Verlag

Autoren