Quick Guide to Good Clinical Practice : How to Meet International Quality Standard in Clinical Research

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies. Front Matter....Pages i-xviii Clinical Trials: Historical Aspects and Importance and New Drug Developments....Pages 1-16 The Definition of GCP....Pages 17-28 The Principles of GCP....Pages 29-32 The Drug Development Process and Evolution of Regulations....Pages 33-43 Planning Clinical Research....Pages 45-56 Preparation of Ethics Committee (IRB) Proposal....Pages 57-61 Preparation of Informed Consent....Pages 63-72 Preparation of Findings Tables....Pages 73-77 Setting the Ideal Statistical Methods....Pages 79-85 The Duties of a Clinical Research Coordinator....Pages 87-96 The Duties of Clinical Researchers....Pages 97-104 The Phases of Clinical Studies....Pages 105-114 Safety in Clinical Trials....Pages 115-120 Setting the Size....Pages 121-127 Setting the Ideal Method....Pages 129-135 Ethics of Clinical Research....Pages 137-148 Recruitment and Enrolment....Pages 149-155 Why We Need Clinical Consent and Other Documentation....Pages 157-171 Monitoring the Trial....Pages 173-178 Inspection....Pages 179-188 Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC)....Pages 189-193 Responsibilities of the Investigator....Pages 195-209 Responsibilities of the Sponsor....Pages 211-230 Clinical Trial Protocols....Pages 231-237