- The lab parameters that should be collected are not specified by the TIG, as this is a medical and scientific decision that is based on the needs of the protocol and regulatory requirements.
- Applicants 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.
- 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 optional and are intended to come directly from the central laboratory.
Overview
Content Tools