Good Clinical Practice : Standard Operating Procedures for Clinical Researchers
- ÜRÜNÜN BULUNDUĞU ŞUBELERİMİZ
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.
Table of Contents:
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.
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.