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What data is shared with FDA?

There are several types of data that FDA receives in the Case for Quality Pilot:

  1. Operational Data
    Adoption metrics (example: # appraisals executed, # days from enrollment to appraisal delivery, etc.).
    Effectiveness metrics (post-appraisal survey regarding appraisal experience and value).

  2. Summary of Individual Appraisal Results
    Specifically, the appraisal location, date, team, and scope, as well as the average percentage for each of the practice areas appraised.

  3. Cumulative Appraisal Results
    The individual practice results (sub-part of practice area) across all completed appraisals and the range of distribution for results across the participant industry. Participants also receive this data.

  4. Performance Report
    Presently, this includes information about each organizations submitted "performance" or "quality" metrics; such as: Quality Domain (Safety, Effectiveness, Availability, Reliability), related business objective, metric definition, indication of good or bad trend (up, down, within range, etc.), and how it used to make informed decisions regarding product quality. The actual measurement of the metric will not be shared, however, derived measures (indicating how the metric is trending) will be shared with FDA after review with the participating manufacturer.
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