Good Clinical Practice: Standard Operating Procedures for Clinical Researchers

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: 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.