Principles of Good Clinical Practice

Description

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.

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.

Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes:

• informed consent
• investigator and sponsor responsibilities
• site monitoring
• institutional review boards and independent ethics committees
• clinical trial registration and reporting
• quality assurance
• future implications for good clinical practices.

Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries.

Contents

1. Introduction to Good Clinical Practice
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 assurance
12. Future Implications of Good Clinical Practice