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Discussion Framework for Clinical Trial Data Sharing Guiding Principles, Elements, and Activities (2014) / Chapter Skim
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Appendix A: Statement of Task
Pages 43-44

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From page 43...
... x For each data sharing activity, the committee will o identify key benefits of sharing and risks of not sharing to research sponsors and investigators, study participants, regulatory agencies, patient groups, and the public. o address key challenges and risks of sharing (e.g., resource constraints, implementation, disincentives in the academic research model, changing norms, protection of human subjects and patient privacy, IP [intellectual property]
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From page 44...
... Focused consideration will also be given to the ethical standards and to integrating core principles and values, including privacy. The committee is not expected to develop or define specific technical data standards.
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Key Terms

  • trial data
  • clinical trial
  • guiding principles
  • responsible sharing
  • data generator

  • sharing activities
  • clinical trials
  • selected set
  • findings regarding
  • include industry

  • restricted access
  • tentative findings
  • industry sponsors
  • interventional clinical
  • specific technical

  • define specific
  • sharing activity
  • data standards
  • researchers conducting
  • sharing data

  • articulate guiding
  • potential adverse
  • responsible entity
  • x describe
  • x articulate

  • adverse consequences
  • include tentative
  • public comment
  • conducting clinical
  • data repositories


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