Reporting and Analytical Needs Addressed

  • Methodology Expert from ScienceTRAX (to be assigned).
  • Principal Investigator, Statician, Study Coordinator.

  • Appropriate staff trained on dissemination features of StudyTRAX.
  • Analytical plan discussed and related datasets in place.
  • Reports set up (i.e., both subject and dataset level).

Typically this step is done once some initial data is collected. The focus will be on training appropriate staff on the dissemination-related features of StudyTRAX, as well as making sure everything is place to execute the analytical plan and reporting needs are addressed (reports about a subject, as well as across subjects). The main issues to address include:

  • Data sets.
    • The fields, structure and format of data sets for planned analyses.
    • Queries (e.g. filters) and main grouping factors to be examined.
  • Transformation of data.
    • Calculated and recoded variables for analysis or reports.
  • Reports / manuscripts.
    • Organize the Workbench around planned reporting needs and academic output.
    • Subject and data set level reports (and subject educational materials).

Identify appropriate staff involved in the dissemination phase (i.e., “reporting” in the broad sense of the term.
Review the reporting features of StudyTRAX:

Plan for reporting and analytical needs at two levels:

  • Subject-level, for example:
    • Color coded data summaries over time.
    • Automated clinic notes, data driven decision analysis.
    • Adverse events reports.
    • Data triggered educational materials or data summaries targeting subjects.
  • Across subject-level, for example:
    • Datasets – raw values, re-coded and calculated variables.
    • Planned manuscripts, associated charts, tables, data sets, files, etc.
    • IRB progress reports.
    • Study safety monitoring reports.