The clinical audit in pharmaceutical development. (1999)

• Record Type: Book
• Further Information: Note: Edited by Michael R. Hamrell.
• Other Names: Hamrell, Michael R, 1952-
• Contents: Introduction to the Clinical Development Process; Michael R. Hamrell; Statutory Requirements and Regulatory Guidance; Tammala Woodrum, Diana B. Lee, and Jon R. Wallace; Source Documentation: Clinical Auditors' Observations; Vernette J. Molloy and Douglas R. Mackintosh; Quality Assurance in Clinical Trials; Richard Kiernan; Standardizing Quality in International Studies; Marijke Korteweg; Good Clinical Practices and Computers; Tammala Woodrum; Food and Drug Administration Audit; Arthur M. Horowitz; GCP Compliance Assessed by Independent Auditing: International Similarities and Difference; W. Boyachuk and G. Ball; Fraud and Misconduct in Clinical Research; Frank Wells; ; Appendix: ENGAGE: European Network of GCP Auditors and Other GCP Experts
• Publisher Details: Place of publication not identified : CRC Press
• Publication Date: 1999
• Extent: 1 online resource (216 pages)
• Subjects: 615/.1901; Drugs -- Testing -- Quality control; Medical audit; Clinical Trials as Topic -- standards; Drug Evaluation -- standards; Guideline Adherence -- standards; Quality Control; Médicaments -- Essais cliniques -- Qualité -- Controle; Soins médicaux -- Évaluation; Drugs -- Testing -- Quality control; Medical audit; Médicaments -- Essais cliniques; Bonnes pratiques cliniques; Qualité -- Contrôle; Klinische Prüfung; Qualitätssicherung; Aufsatzsammlung
• Languages: English
• ISBNs: 9781420001266; 1420001264
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.