Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections (Record no. 15232)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01673nam a2200181Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b2010 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780470248850 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.580724 |
| Item number | MIH |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Mihajlovic - Madzarevic, Vera |
| 245 ## - TITLE STATEMENT | |
| Title | Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc. | New Jersey |
| Name of publisher, distributor, etc. | John and Wiley Sons, Inc. |
| Date of publication, distribution, etc. | 2010 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 246p |
| 500 ## - GENERAL NOTE | |
| General note | 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 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. |
| 600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME | |
| Personal name | Audit Preparation |
| 890 ## - | |
| -- | USA |
| 891 ## - | |
| -- | People - Health - Good health {QuickPic} |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
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| -- | Himanshu Book Co. |
| -- | Reference |
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