Good Clinical Practice
Standard Operating Procedures for Clinical Researchers
(Sprache: Englisch)
Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional...
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Klappentext zu „Good Clinical Practice “
Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:* A brief description of the history and development of clinical research and good clinical practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.
Inhaltsverzeichnis zu „Good Clinical Practice “
Clinical ResearchPhases of a Clinical Trail
Clinical Trial Design
History and Development of GCP
Good Clinical Practice - What is It?
Responsibilities of the Investigator
Standard Operating Procedures
Organisation of Clinical Trials
Abbreviations
SOP 0: Preparation, Approval and Review of SOPs
SOP 1: Study Organisation and Planning
SOP 2: Study Team: Definition of Responsibilities
SOP 3: Study Files and Filing
SOP 4: Local Management Requirements
SOP 5: Review and Validation of the Protocol
SOP 6: Review of Protocol Amendments
SOP 7: Case Report Form (CRF) Review
SOP 8: Investigator's Brochure
SOP 9: Estimation of Patient Numbers
SOP 10: Ethics Committee
SOP 11: Indemnity, Compensation and Insurance
SOP 12: Laboratory
SOP 13: Pre-Study Monitoring Visits
SOP 14: Patient Recruitment and Intention to Enrol
SOP 15: Obtaining Personal Written Informed Consent
SOP 16: Obtaining Informed Consent for Patients Unable to Give Personal Consent
SOP 17: Randomisation and Stratification
SOP 18: Blinding: Codes and Code Breaking
SOP 19: Case Report Form (CRF) Completion
SOP 20: Study Drugs
SOP 21: Monitoring Visits
SOP 22: Adverse Event and Serious Adverse Event Reporting
SOP 23: Nursing Procedures
SOP 24: Clinical Procedures
SOP 25: Trial Report
SOP 26: Archiving
SOP 27: Audits and Inspections
FDA Regulations Concerning Clinical Trials
Index
Bibliographische Angaben
- 1998, 1. Auflage, XII, 178 Seiten, Maße: 23,9 cm, Kartoniert (TB), Englisch
- Herausgegeben: Josef Kolman, Paul Meng, Graeme Scott
- Verlag: Wiley & Sons
- ISBN-10: 0471969362
- ISBN-13: 9780471969365
Sprache:
Englisch
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