Table 3.

Current thinking on clinical investigator site inspections and the potential for discrepant PRO and clinician-reported outcome symptom results

IssueCurrent thinking
Would discrepancies between patient (e.g., PRO-CTCAE) and clinical investigator/clinician (CTCAE) results for a particular symptomatic AE affect FDA clinical investigator site inspection findings?
  • PRO (e.g., PRO-CTCAE) data are complementary to clinical investigator/clinician CTCAE data but are expected to differ and may not correlate.

  • PRO symptomatic AE results should not inform gaps or errors in CTCAE reporting during clinical investigator site inspection.