Principles of good clinical practice

Good clinical practice guidelines providing an international quality standardfor the regulation of clinical trials. This title is one of the "RPS PharmacyBusiness Administration Series" which aims at covering all business aspects relating to pharmacy practice. Good Clinical Practice is an international quality standard for the regulation of clinical trials. GCP guidelines 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 aimsto be a one-stop source for guidance and checking the rules for proper conduct of clinical trials. It also includes historical development, trends, review of current system and future development. INDICE: 1. Introduction; 2. Regulatory Requirements; 3. Institutional Review Boards; 4. Monitoring; 5. Responsibilities of the Investigator; 6. Responsibilities of the Sponsor; 7. Clinical trial design; 8. Clinical trials registration and reporting; 9. Informed Consent; 10. Pharmacovigilance; 11. Auditing and Inspections; 12. Future implications for good clinical practices

• ISBN: 978-0-85369-790-9
• Editorial: Pharmaceutical Press
• Encuadernacion: Rústica
• Páginas: 288
• Fecha Publicación: 30/07/2010
• Nº Volúmenes: 1
• Idioma: Inglés