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  1. The lab parameters that should be collected are not specified by CDASHthe TIG, as this is a medical and scientific decision that is 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 Medical History or 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.All pertinent laboratory normal ranges/units and laboratory certification for all laboratories used during the study will be provided to the sponsor. This is required for regulatory and database purposes.
  5. This is a specimen-based domain. LBDTC is the date the specimen was collected.
  6. LOINC code should not be applied to local lab data by the sponsor. LOINC codes are intended are optional and are intended to come directly from the central laboratory.