Clinical Research Law And Compliance Handbook / Edition 1

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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.

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Product Details

  • ISBN-13: 9780763747251
  • Publisher: Jones & Bartlett Learning
  • Publication date: 5/24/2005
  • Edition description: 1E
  • Edition number: 1
  • Pages: 460
  • Sales rank: 1,322,873
  • Product dimensions: 6.84 (w) x 9.22 (h) x 1.16 (d)

Table of Contents

Ch. 1 Key compliance issues for academic medical organizations 1
Ch. 2 Contract issues in clinical trials 59
Ch. 3 Clinical research billing : process and monitoring issues 107
Ch. 4 Clinical research trials : operational and budget issues 145
Ch. 5 Fraud and abuse in clinical research 169
Ch. 6 Uses and disclosures of identifiable information in clinical research : national and international considerations 221
Ch. 7 Identifying applicable laws and reducing key risks in nonregistrational, postmarketing studies 265
Ch. 8 Key compliance issues for institutional review boards 299
Ch. 9 Conflicts of interest in biomedical research - avoiding bias 335
Ch. 10 Enhancing data quality and patient safety through the use of technology in clinical trials 361
Ch. 11 Legal issues in the conduct of multinational clinical trials by U.S. entities 385
Ch. 12 Clinical research trials in the courtroom 411
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