Guide for Investigator Initiated Trials

by G. Fortwengel (Editor)

Overview

For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.

Product Details

ISBN-13:	9783805596855
Publisher:	Karger, S. Inc.
Publication date:	01/01/2011
Sold by:	CIANDO
Format:	eBook
Pages:	154
File size:	3 MB

Editorial Reviews

Reviewer: Vincent F Carr, DO, MSA, FACC, FACP (Uniformed Services University of the Health Sciences)
Description: This is a reference for new research investigators preparing a protocol for consideration by one of the European Health Authorities. It uses an outline format with topics and supporting prose to help investigators prepare and submit a protocol.
Purpose: There is no preface but the table of contents clearly outlines what the book addresses. In an era when there are so many comparisons between the European and American research and approval mechanisms, this is a nice way to see how the European approach may differ and how it may affect the results. This compact and simple book is extremely useful.
Audience: Anyone in the European arena can use this as a checklist and guide, but the book also is tremendously useful for those in the administration of research funds to compare approaches and see if there are better ways to look at the status quo.
Features: The combination of the book's outline format and the associated website with templates and example documents is very useful. The subjects are clear, with added information only when necessary and references to the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), and the European Union Directives.
Assessment: This is a tremendously valuable book with utility for researchers and administrators on both sides of the Atlantic. I highly recommend it for every research library.

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