Kolman J., Meng P., Scott G. Good Clinical Practice: Standard Operating Procedures for Clinical Researchers

Chichester: John Wiley & Sons, 2001. — 187 p.Standard Operating Procedures (SOPs) have become the normal way by which Sponsor pharmaceutical and medical device companies document the processes they adopt for the initiation, conduct and reporting of clinical trials, i.e. attempt to minimize the effects of Murphy’s Law. Adoption of SOPs has progressed in parallel with the evolution of GCP (see Introduction) and the various GCP guidelines require Sponsors to maintain a sufficiently comprehensive and up-to-date set of SOPs. This book provides a comprehensive ‘bank’ of SOPs to enable Investigators to generate a set that is appropriate for their use with the minimum of effort. This can be achieved by customizing those selected, e.g. to reflect the specific organization of the site. If greater specificity is desired, the degree of customization can be increased. The benefit of this publication is that the basic SOP structures are ready made, minimizing the effort needed to construct a portfolio of relevant SOPs.List of Contributors
Foreword
AcknowledgementsClinical Research
Phases of a Clinical Trial
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
Preparation, Approval and Review of Sops
Study Organisation and Planning
Study Team: Definition of Responsibilities
Study Files and Filing
Local Management Requirements
Review and Validation of The Protocol
Review of Protocol Amendments
Case Report Form (CRF) Review
Investigator’s Brochure
Estimation of Patient Numbers
Ethics Committee
Indemnity, Compensation and Insurance
Laboratory
Pre-Study Monitoring Visits
Patient Recruitment and Intention to ENROL
Obtaining Personal Written Informed Consent
Obtaining Informed Consent for Patients Unable
To Give Personal Consent
Randomisation and Stratification
Blinding: Codes and Code Breaking
Case Report Form (CRF) Completion
Study Drugs
Monitoring Visits
Adverse Event and Serious Adverse Event
Reporting
Nursing Procedures
Clinical Procedures
Trial Report
Archiving
Audits and Inspections
FDA Regulations Concerning Clinical Trials