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We consider “clinical trial data” to refer to the totality of recorded information related to a clinical trial. Therefore this definition includes not only all datasets from trials, but also the many pre-trial and post-trial documents that are created in the course of designing, running, and reporting a trial (such as the trial protocol, statistical analysis plan, blank and completed case report forms, randomization lists, etc., trial reports e.g. clinical study report, trial publication, and so on). Even meeting minutes, marketing assessments, and email correspondence about trials are included in “clinical trial data,” and may be helpful or even necessary to fully understand a trial.

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See our glossary for definitions

  1. Journal publication and/or conference abstract or poster
  2. Clinical Study Report (CSR)
  3. Study Protocol and amendments
  4. Sample Case Report Form (CRF)
  5. Statistical Analysis Plan (SAP)
  6. Certificate of analysis
  7. Sample Informed Consent form
  8. Manual of Operations
  9. Electronic Individual Participant Data (IPD)
  10. Completed Case Report Forms
  11. Laboratory reports
  12. Medical records and diagnostic reports
  13. Investigator’s Brochure (IB)
  14. Marketing Assessments
  15. Email correspondence
  16. Meeting minutes
  17. Records of the Data Monitoring Committee (aka DSMB)
  18. Medical officer review
  19. Advisory committee memoranda
  20. Regulatory site inspection reports

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