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Discussion Framework for Clinical Trial Data Sharing Guiding Principles, Elements, and Activities (2014) / Chapter Skim
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Appendix C: Figure 1: Data Flow from Participant to Analyzed Data and Reporting
Pages 57-58

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From page 57...
... This protocol is approved by an institutional review board and explained to participants through the informed consent process. Depending on the study under consideration, demographics, clinical outcomes data, and other appropriate raw source information are entered into case report forms.
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From page 58...
... Analyses that were prespecified in the Statistical Analysis Plan form the basis for the Clinical Study Report (CSR) (a detailed analysis of the study efficacy data and the complete adverse event data)
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Key Terms

  • cleaned analyzable
  • adverse event
  • trial data
  • clinical trial
  • event data

  • locked analyzable
  • report forms
  • key secondary
  • primary outcome
  • review board

  • informed consent
  • efficacy data
  • prespecified secondary
  • coded data
  • medicines agency

  • lyzable dataset
  • efficacy outcomes
  • analysis plan
  • plan form
  • hypothesis generation

  • research protocol
  • primary efficacy
  • participant characteristics
  • exploratory data
  • cleaned dataset

  • usually describes
  • detailed analysis
  • source information
  • raw source
  • adverse events


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