Edited by Josef Kolman, Medical Pharmaceutical Research Center Ltd, Vienna, Austria, Paul Meng, Consultant, Vienna, Austria and, Graeme Scott, Professional Services in Clinical Research, Scotland, UK

"Anyone concerned with clinical research, especially trials of drugs and medical devices, might find that it saves them a lot of time." - British Medical Journal

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, for example, 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 operating procedures and checklists

Contents

• Introduction
• Clinical Research
• Phases of a Clinical Trial
• Clinical Trial Design
• History & Development of GCP
• Good Clinical Practice - What is it?
• Responsibilities of the Investigator
• Standard Operating Procedures
• Organisation of Clinical Trials
• SOP 0 - Preparation, Approval & Review of SOPs
• SOP 1 - Study Organisation & 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 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 - Pharmacy
• SOP 14 - Pre-Study Monitoring Visits
• SOP 15 - Patient Recruitment & Intention to Enroll
• SOP 16 - Obtaining Personal Written Informed Consent
• SOP 17 - Obtaining Informed Consent from Patients Unable to Give Personal Consent
• SOP 18 - Randomisation and Stratification
• SOP 19 - Blinding: Codes and Code Breaking
• SOP 20 - Case Report Form (CRF) Completion
• SOP 21 - Study Drugs
• SOP 22 - Monitoring Visits
• SOP 23 - Adverse Event & Serious Adverse Event Reporting
• SOP 24 - Nursing Procedures: Examples
• SOP 25 - Clinical Procedures
• SOP 26 - Trial Report
• SOP 27 - Archiving
• SOP 28 - Audits and Inspections
• FDA Regulations Concerning Clinical Trials
• FDA Documentation, Record Keeping and Record Retention
• Investigator Record Keeping and Record Retention