Medical Document/Form

A Medical Document/Form is a Document that contains medical data about a patient, a medical intervention/treatment, and/or a clinical trial.

• Example(s):
  • Case Report Form (CRF),
  • Clinical Trial Protocol Document,
  • Informed Consent Form (ICF),
  • Medical Records.
  • …
• Counter-Example(s):
  • Clinical Trial Audit Certificate,
  • Clinical Trial Audit Trail,
  • Clinical Outcome Assessment (COA) Instrument,
  • FDA Approval Certificate.
• See: Clinical Data Management System, Good Clinical Practice, Clinical Efficacy Measure, Ethical Clinical Research, Medical Device.

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