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Research ArticleAdministrative and Regulatory Issues

Current Challenges and Opportunities in Clinical Research Compliance

Wendy Portier and Claire Dunne
Ochsner Journal March 2006, 6 (1) 21-24;
Wendy Portier
Compliance Officer - Director of Compliance & Audit
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Claire Dunne
Managing Auditor
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REFERENCES

  1. ↵
    1. Clinical Trials Compliance
    (June 2003) FDA warning letter signals move to tighten oversight. Strategies for Medicare Billing, FDA, and Research Compliance, 2, 1–12.
  2. ↵
    1. Office of the Inspector General
    (2003) Work Plan. Retrieved October 14, 2003 from the World Wide Web: http://oig.hhs.gov/publications/workplan.html.
  3. ↵
    1. Federal Register
    (September 2003) Solicitation of Information and Recommendations for Developing Compliance Program Guidance for Recipients of NIH Research Grants. Retrieved October 14, 2003 from the World Wide Web: http://oig.hhs.gov/authorities/docs/FRcpgNIHsolicitation.pdf.
  4. ↵
    1. Office of the Inspector General
    (CPG (2003)) Compliance Program Guidance for Pharmaceutical Manufacturers. Retrieved October 14, 2003 from the World Wide Web: http://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf.
  5. ↵
    1. Clinical Trials Compliance
    (September 2003) Sidestepping the five most common FDA compliance pitfalls, 2(9):1–3, Strategies for Medicare Billing, FDA, and Research Compliance.
  6. ↵
    1. Gillis J.
    (June, 2002) A hospital's conflict of interest - Patients weren't told of stake in cancer drug. Retrieved October 14, 2003 from the World Wide Web: http://www.commondreams.org/headlines02/0630-03.htm.
  7. ↵
    1. Haan H.
    (September, 2003) American Academy of Pharmaceutical Physicians. Retrieved October 14, 2003 from the World Wide Web: http://aapp.org/pdf/HansMayoPresentation.pdf.
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Current Challenges and Opportunities in Clinical Research Compliance
Wendy Portier, Claire Dunne
Ochsner Journal Mar 2006, 6 (1) 21-24;

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Current Challenges and Opportunities in Clinical Research Compliance
Wendy Portier, Claire Dunne
Ochsner Journal Mar 2006, 6 (1) 21-24;
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  • Clinical Research Education: Responding to a Changing Environment
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