Description
Book SynopsisAn essential book for all those clinicians and reserachers undertaking clinical trials. It will ensure that all involved in clinical trials undertake their investigation according to standard operating procedures.
Table of ContentsClinical 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: 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.
