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  <titleInfo>
    <title>Data monitoring in clinical trials</title>
    <subTitle>a practical perspective</subTitle>
  </titleInfo>
  <titleInfo type="uniform">
    <title>Data monitoring in committees in clinical trials</title>
  </titleInfo>
  <name type="personal">
    <namePart>Ellenberg, Susan Smith</namePart>
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    <role>
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  <name type="personal">
    <namePart>Fleming, Thomas R.</namePart>
    <role>
      <roleTerm type="text">author.</roleTerm>
    </role>
  </name>
  <name type="personal">
    <namePart>DeMets, David L.</namePart>
    <namePart type="date">1944-</namePart>
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    </role>
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  <originInfo>
    <place>
      <placeTerm type="code" authority="marccountry">nju</placeTerm>
    </place>
    <dateIssued encoding="marc">2019</dateIssued>
    <edition>Second edition.</edition>
    <issuance>monographic</issuance>
  </originInfo>
  <language>
    <languageTerm authority="iso639-2b" type="code">eng</languageTerm>
  </language>
  <physicalDescription>
    <form authority="marcform">print</form>
    <extent>xxii, 468 pages : illustrations</extent>
  </physicalDescription>
  <tableOfContents>Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs.</tableOfContents>
  <note type="statement of responsibility">Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets.</note>
  <note>Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002.</note>
  <note>Includes bibliographical references and index.</note>
  <subject authority="mesh">
    <topic>Clinical Trials Data Monitoring Committees</topic>
    <topic>organization &amp; administration</topic>
  </subject>
  <subject authority="mesh">
    <topic>Clinical Trials as Topic</topic>
  </subject>
  <subject authority="mesh">
    <topic>Data Collection</topic>
    <topic>methods</topic>
  </subject>
  <subject authority="mesh">
    <topic>Clinical Trials Data Monitoring Committees</topic>
    <topic>ethics</topic>
  </subject>
  <classification authority="nlm">W 20.55.C5 2019</classification>
  <relatedItem type="series">
    <titleInfo>
      <title>Statistics in practice</title>
    </titleInfo>
  </relatedItem>
  <identifier type="isbn">9781119512653 (hardcover)</identifier>
  <identifier type="lccn">2018043881</identifier>
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    <recordCreationDate encoding="marc">201012</recordCreationDate>
    <recordChangeDate encoding="iso8601">20201012165551.0</recordChangeDate>
    <recordIdentifier source="TH-BaNU">1733936</recordIdentifier>
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