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OSI Metrics Overview

  • This presentation: OSI Metrics - December 2016 (PDF - 2MB) (updated: December 2016) provides annual inspection metrics for the compliance programs overseen by the Office of Scientific Investigations, or OSI and the Office of Study Integrity and Surveillance, or OSIS, in FDA’s Center for Drug Evaluation and Research (CDER). The vast majority of these inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).
    • The slides contain information from FY2016.
    • Footnotes in individual slides indicate where significant changes from previous versions have occurred. These changes are due to improvements to OSI’s database and associated processes.
  • As FDA’s approval decisions are based on a review of the data submitted to the agency by an applicant, it is essential for the agency to ensure the integrity of the data submitted and to verify that the rights, health and welfare of those who participated in the studies were protected and that applicants continue to meet their obligations (e.g. for safety reporting) after approval.
  • Onsite inspection is one of many tools the FDA has for ensuring the integrity of data, the health and welfare of research participants, and the protection of public health.
  • Data source
    • Information was extracted from CDER's database Complis and other sources as noted.
  • Data conventions
    • These metrics are based on key events during the inspection process, including starting an inspection, issuing an inspection assignment, or issuing post-inspectional correspondence to the inspected party.
    • Differences in inspection counts when comparing data across varying sources may be the result of different tallying methods of inspection-related data.
  • For further information, please contact 301-796-3150.

 

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