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, ...
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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.
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Add this copy of Guide for Investigator Initiated Trials to cart. $42.99, new condition, Sold by discount_scientific_books rated 5.0 out of 5 stars, ships from Sterling Heights, MI, UNITED STATES, published 2011 by S Karger AG.
Add this copy of Guide for Investigator Initiated Trials to cart. $115.64, new condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2011 by S Karger Ag.
Looked for a book with similar content all over the web but found it on Alibris.
Contains comprehensive background on regulatory, ICF, IBs, Insurance, data management, etc, etc, for those new to the basics of IISs; however, was written totally from the perspective of pharmaceuticals. Did not contain information on devices! A major oversight.