Good clinical practice : standard operating procedures for clinical researchers /
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| Imprint: | Chichester ; New York : J. Wiley & Sons, c1998. |
|---|---|
| Description: | xi, 177 p. : ill. ; 25 cm. |
| Language: | English |
| Subject: | Clinical trials -- Standards. Clinical Trials -- standards. Research Design -- standards. Clinical trials -- Standards. |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/3781290 |
Table of Contents:
- Clinical Research
- Phases 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. Investigatora'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
