Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 8, 2001 - Issue 3
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Original Articles

Clinical trials integrity: A CRO perspectiveFootnote*

Pages 245-260 | Published online: 11 Jun 2008

References

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  • FDA, 21 CFR Part 56. Institutional Review Boards
  • FDA, 21 CFR Part 312. Investigational New Drug Application (IND)
  • FDA, 21 CFR Part 314. Applications (and abbreviated applications) for FDA approval to market a new drug
  • FDA, 21 CFR Part 54. Financial Disclosure
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  • Woolen , S. 2000 . Patient Misuse and Investigator Fraud in Clinical Trials: What Can Be Done? Part I . Power Point Slides , June 14 http://www.fda.gov/cder/present/ dia‐62000/wooleni/indexhtm (visited website January 17,2001)
  • 2000 . OHRP halts human research at University of Oklahoma for subject protection violations . Guide to Good Clinical Practice , 7 ( 1 ) September : 4 – 5 .
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  • The Business of Human Experiments: Ethical, Legal and Regulatory Issues, Third National Ethics Conference, Sponsored by Friends Research Institute, Inc. November 3–5, 2000.
  • Corresponding author. Tel.: 919–998–2072. Fax: 919–998–2090. E‐mail: [email protected].

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