Clinical Research Law And Compliance Handbook / Edition 1

Clinical Research Law And Compliance Handbook / Edition 1

by John E. Steiner Jr.
     
 

ISBN-10: 0763747254

ISBN-13: 9780763747251

Pub. Date: 05/24/2005

Publisher: Jones & Bartlett Learning

Written in clear, practical language, this title will help you navigate the clinical research maze as it addresses critically important legal, operational, ethical and business issues associated with clinical research trials.  See more details below

Overview

Written in clear, practical language, this title will help you navigate the clinical research maze as it addresses critically important legal, operational, ethical and business issues associated with clinical research trials.

Product Details

ISBN-13:
9780763747251
Publisher:
Jones & Bartlett Learning
Publication date:
05/24/2005
Edition description:
1E
Pages:
460
Product dimensions:
6.84(w) x 9.22(h) x 1.16(d)

Table of Contents

Ch. 1Key compliance issues for academic medical organizations1
Ch. 2Contract issues in clinical trials59
Ch. 3Clinical research billing : process and monitoring issues107
Ch. 4Clinical research trials : operational and budget issues145
Ch. 5Fraud and abuse in clinical research169
Ch. 6Uses and disclosures of identifiable information in clinical research : national and international considerations221
Ch. 7Identifying applicable laws and reducing key risks in nonregistrational, postmarketing studies265
Ch. 8Key compliance issues for institutional review boards299
Ch. 9Conflicts of interest in biomedical research - avoiding bias335
Ch. 10Enhancing data quality and patient safety through the use of technology in clinical trials361
Ch. 11Legal issues in the conduct of multinational clinical trials by U.S. entities385
Ch. 12Clinical research trials in the courtroom411

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