Good Clinical Practices Guide

The most time-consuming and expensive task in achieving approval to market a new drug, biological or medical device is to confirm the safety and efficacy of the product by testing it on human subjects. In order to ensure that the clinical trials or studies are performed in a scientific, humane and ethical manner, codes of Good Clinical Practice (GCP) have been drawn up by most countries and are now the subject of international agreement. A clinical study is initiated and monitored by the Sponsor, planned and performed by the Investigator and reviewed and approved by the Institutional Review Board (IRB). This Guide examines in detail the responsibilities and activities of these three main parties and gives practical advice to assist each to fulfill their obligations. To support the work of these three main participants in the clinical study process, numerous forms and check-lists have been prepared and some of them are incorporated into official Guidelines. The most relevant of these have been reproduced in this Guide and may be copied by readers for their own use. The Guide will assist these people to structure and monitor the study so as to ensure its acceptance by the regulatory agencies as being unbiased, accurate and humane.

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