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OrderQuestion TextPromptCRF Completion InstructionsCDASH Variable Name SDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What was the name of the lab panel?Lab Panel NameRecord the lab test category, if not pre-printed on the CRF.LBCATLBCAT

HEMATOLOGY; CLINICAL CHEMISTRY; URINALYSIS


2Was the lab performed?Lab PerformedIndicate whether or not lab specimen was collected, or measurement performed.LBPERFLBSTATLBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y"(NY)Yes; No
3What was the date of the lab specimen collection?Specimen Collection DateRecord the date of specimen collection using this format (DD-MON-YYYY).LBDATLBDTC



4What was the name of the laboratory used?Laboratory NameRecord the laboratory name.LBNAMLBNAM



5What is the lab test name?Lab Test NameRecord the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.LBTESTLBTEST;   LBTESTCDLBTEST and  LBTESTCD(LBTEST)WBC;  RBC,  cells,Protein  Urinalysis; Cholesterol, Albumin, Creatinine
6What was the result of the lab test?ResultRecord laboratory test result.LBORRESLBORRES



7What was the unit of the lab result?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.LBORRESULBORRESU
(UNIT)g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO
8What was the lower limit of the reference range for this lab test?Normal Range Lower LimitRecord the lower limit of the reference range of the lab test.LBORNRLOLBORNRLO



9What was the high limit of the reference range for this lab test?Normal Range Upper LimitRecord the upper limit of the reference range of the lab test.LBORNRHILBORNRHI



10How do the reported values compare within the reference range?Comparison to Reference RangeRecord where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW).LBNRINDLBNRIND
(NRIND)High; Normal; Low
11Was this result clinically significant?Clinically SignificantRecord whether lab results were clinically significant.LBCLSIGLBCLSIG
(NY)Yes; No

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