- The lab parameters that should be collected are not specified by CDASH, as this is a medical and scientific decision that is based on the needs of the protocol.
- Sponsors should decide which scenario is appropriate for each protocol.
- As required or defined by the study protocol, clinically significant results may need to be reported on the Medical History or Adverse Event CRF.
- 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.
- This is a specimen-based domain. LBDTC is the date the specimen was collected.
- LOINC code should not be applied to local lab data by the sponsor. LOINC codes are intended to come directly from the central laboratory.
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