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  1. The ECG tests that should be collected are not specified by CDASHthe TIG; this is a medical and scientific decision that should be based on the needs of the protocol and regulatory requirements.
  2. Sponsors Applicants should decide which scenario is appropriate for each protocol.
  3. As required or defined by the study protocol, clinically significant results may need to be reported on the Adverse Event CRF.
  4. As required or defined by the study protocol, changes that are worsening may need to be reported on the AE CRF.
  5. As depicted in scenario 3, where the CRF includes site assessment of clinical significance and/or overall interpretation, results are returned to the sites, and the sites complete a CRF page of clinical significance for any abnormal/unexpected values and/or record an overall interpretation of the results. As in scenario 1, the actual testing results are transmitted electronically, but the CRF includes data necessary to identify and rate the clinical significance of the abnormal results.