Wendy Bohaychuk and Graham Ball, Good Clinical Research Practices Ltd., Hampshire, UK

During the period when drugs are being developed and clinical trials undertaken, all research activities must comply to good clinical practice guidelines to protect the study subjects and to satisfy the regulators for licensing.

Providing a general framework for conducting GCP compliant clinical research (particularly pharmaceutical industry clinical research), this comprehensive reference is written in a simplistic manner so that it can be easily followed by those new to the industry. The use of numerous examples taken from the authors' years of practice will also appeal to more experienced readers.

• Written in an 'easy-to-read' manner
• Contains numerous true-life stories outlining what can and does go wrong in clinical research
• Highly practical - a 'how-to' book designed to be accessible to both newcomers and experienced researchers
• Incorporates case studies, anecdotes and checklists designed to help prepare standard operating procedures
• Includes numerous references to audit findings

Contents

• The Current Rules for Conducting Clinical Research
• The Basic Tenets of GCP; The General Regulatory Framework for GCP; Standard Operating Procedures; Clinical Research Auditing; Regulatory Inspections; Fraud. The Ultimate Non-Compliance in GCP
• Setting up Clinical Studies
• Protocols; CRFs and Other Data Collection Forums; Investigator Brochures; Regulatory Requirements; Selection of Investigators and Study Sites; Qualifications of Clinical Research Personnel; Study Agreements; Selection of CRO's; Selecting Clinical Laboratories; Initiation Visits
• Ethical Considerations
• Ethics Committee/IRB Review and Approval; Documentation of Safe Ethics Committee/IRB Approval; Conduct of Informed Consent; Information to be Provided to Study Subjects in Clinical Studies
• Monitoring and Safety Reporting
• Monitoring; Protocol Violations and Protocol Amendments; Reporting and Recording Safety Events
• Collecting Data with Integrity
• The Difference Between Source Documents and CRFs; Access to Source Documents; Source Data Verification; Data Queries; General Internal Data Processing; General Statistical Procedures
• Managing Study Medications/Devices
• Preparation of Study Medications/Devices; Shipment of Study Medications/Devices; Control of Study Medications/Devices at Study Sites; Overall Accountability of Study Medications/Devices; Randomisation and Blinding; Management of Clinical Laboratory Samples
• Final Stages in Clinical Studies
• Closure of Clinical Studies; Final Clinical Reports; Archiving