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Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections /
A must-have guide for any professional in the drug manufacturing industry. The 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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2010.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 100 | 1 | |a Mihajlovic-Madzarevic, Vera. | |
| 245 | 1 | 0 | |a Clinical trials audit preparation : |b a guide for good clinical practice (GCP) inspections / |c Vera Mihajlovic-Madzarevic. |
| 260 | |a Hoboken, N.J. : |b Wiley, |c ©2010. | ||
| 300 | |a 1 online resource (xxi, 246 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a data file |2 rda | ||
| 380 | |a Bibliography | ||
| 505 | 0 | |a Good clinical practice and therapeutic product development -- Therapeutic products clinical development in the United States -- The inspection preparation -- Analysis of warning letters -- Fraud and misconduct in clinical research -- Appendix A: some answers to the most problematic questions in compliance -- Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance -- Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects -- Appendix D: Nuremberg Code -- Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research. | |
| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Print version record. | |
| 520 | |a A must-have guide for any professional in the drug manufacturing industry. The 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 instit. | ||
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Drugs |x Testing |x Auditing. | |
| 650 | 0 | |a Medical audit. | |
| 650 | 0 | |a Quality control. | |
| 650 | 2 | |a Clinical Trials as Topic |x standards | |
| 650 | 2 | |a Guideline Adherence |x standards | |
| 650 | 2 | |a Management Audit | |
| 650 | 2 | |a Quality Control | |
| 650 | 2 | |a Medical Audit | |
| 650 | 6 | |a Soins médicaux |x Évaluation. | |
| 650 | 6 | |a Gestion |x Contrôle. | |
| 650 | 6 | |a Qualité |x Contrôle. | |
| 650 | 7 | |a quality control. |2 aat | |
| 650 | 7 | |a MEDICAL |x Chemotherapy. |2 bisacsh | |
| 650 | 7 | |a Quality control |2 fast | |
| 650 | 7 | |a Medical audit |2 fast | |
| 758 | |i has work: |a Clinical trials audit preparation (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGTyrbf8KbcFjHj3r4kfVP |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Mihajlovic-Madzarevic, Vera. |t Clinical trials audit preparation. |d Hoboken, N.J. : John Wiley, ©2010 |z 9780470248850 |w (DLC) 2009027971 |w (OCoLC)423572734 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=624561 |z Texto completo |
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