Clinical Trials Audit Preparation
By:
Sign Up Now!
Already a Member? Log In
You must be logged into Bookshare to access this title.
Learn about membership options,
or view our freely available titles.
- Synopsis
- A must-have guide for any professional in the drug manufacturing industryThe Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.Among the topics discussed:Good Clinical Practices and therapeutic product development in clinical researchThe roles of the sponsor of a clinical investigation, the IRB, or independent ethics committeeThe roles and responsibilities of the clinical trial investigatorThe inspection preparationThe Audit Report and the Form 483Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
- Copyright:
- 2010
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9780470920886
- Related ISBNs:
- 9780470248850
- Publisher:
- Wiley
- Date of Addition:
- 06/08/14
- Copyrighted By:
- John Wiley & Sons
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.