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  <titleInfo>
    <title>Clinical research law and compliance handbook</title>
  </titleInfo>
  <name type="personal">
    <namePart>Steiner, John (John E.)</namePart>
    <role>
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    <place>
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    <publisher>Jones and Bartlett Publishers</publisher>
    <dateIssued>c2006</dateIssued>
    <dateIssued encoding="marc">2006</dateIssued>
    <issuance>monographic</issuance>
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    <extent>xxx, 460 p. ill., forms 24 cm.</extent>
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  <tableOfContents>Practical legal and compliance issues in clinical trials / John steiner, editor -- Contract issues in domestic clinical trials / Donna J. Meyer -- Clinical research billing : process and monitoring issues / John E. Steiner, Jr., F. Lisa Murtha -- Clinical research trials : operational and budget issues / Bill Hunt, Sue O'Connell -- Fraud &amp; abuse in clinical research / Karen Owen Dunlop and William A. Sarraille -- Uses and disclosures of identifiable information in clinical research : national and international considerations / M. peter Adler, Jeffrey G. Micklos -- Identifying applicable laws and reducing key risks in non-registrational post-marketing studies / Judith E. Beach, Nancy Strehlow -- Key compliance issues for institutional review Boards / Michael J. Meehan, and Marleina Thomas Davis -- Conflicts of interest in biomedical research - avoiding bias / Kendra Dimond and Joseph B. Clamon -- Enhancing data quality and patient safety through the use of technology in clinical trials / Jeffrey A. Green and Marc Shlaes -- Legal issues in the conduct of multinational clinical trials / by Jan E. Murray -- Clinical trials in the courtroom / Andrew Agati.</tableOfContents>
  <note type="statement of responsibility">edited by John E. Steiner, Jr.</note>
  <note>Includes bibliographical references and index.</note>
  <subject>
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  <subject authority="lcsh">
    <topic>Clinical trials</topic>
    <topic>Law and legislation</topic>
    <geographic>United States</geographic>
  </subject>
  <subject authority="gtt">
    <topic>Patiënten</topic>
  </subject>
  <subject authority="gtt">
    <topic>Onderzoek</topic>
  </subject>
  <subject authority="gtt">
    <topic>Wetgeving</topic>
  </subject>
  <subject authority="gtt">
    <topic>Clinical trials</topic>
  </subject>
  <subject authority="mesh">
    <topic>Guideline Adherence</topic>
    <geographic>United States</geographic>
  </subject>
  <subject authority="mesh">
    <topic>Clinical trials</topic>
    <topic>legislation &amp; jurisprudence</topic>
    <geographic>United States</geographic>
  </subject>
  <subject authority="lcsh">
    <topic>Medicine</topic>
    <topic>Research</topic>
    <topic>Law and legislation</topic>
    <geographic>United States</geographic>
  </subject>
  <classification authority="lcc">KF3821 .S736 2006</classification>
  <classification authority="ddc" edition="22">344.73041 S8221c</classification>
  <classification authority="nlm">2005 I-184</classification>
  <classification authority="nlm">W 32.5 AA1 C599 2006</classification>
  <identifier type="isbn">0763747254 (alk. paper)</identifier>
  <identifier type="lccn">2005008613</identifier>
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    <recordIdentifier source="OCoLC">279463</recordIdentifier>
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