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This is an example CRF used to collect routine safety labortory tests from local laboratories in tobacco studies. The lab names may be collected only when multiple labs are used by a site. The lab test name are often pre-printed on the CRF. The names are not included as they are study specific. In order to save space, some of the permissible values are only shown in the metadata specifications. 

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What was the name of the laboratory used?Laboratory NameRecord the laboratory nameTextLBNAMLBNAM



2Was the lab performed?Lab PerformedIndicate whether or not lab specimen was collected, or measurement performed.TextLBPERFLBSTATLBSTAT = "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 .DateLBDATLBDTC



4What was the time of the lab specimen collection?Specimen Collection TimeRecord time of collection (as complete as possible).TimeLBTIMLBDTC



5Was the subject fasting? FastingRecord whether the subject was fasting prior to the test being performedTextLBFASTLBFAST



Section  2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
6What 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 applicant may provide additional instructions to ensure the data is entered as intended.TextLBTESTLBTEST;   LBTESTCDLBTEST and  LBTESTCD(LBTEST)WBC;  RBC,  cells,Protein  Urinalysis; Cholesterol, Albumin, Creatinine
7What was the result of the lab test?ResultRecord laboratory test result.TextLBORRESLBORRES



8What 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.TextLBORRESULBORRESU
(UNIT)g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO
9What 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.TextLBORNRLOLBORNRLO



10What 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.TextLBORNRHILBORNRHI



11Was this result clinically significant?Clinically SignificantRecord whether lab results were clinically significant.TextLBCLSIGLBCLSIG
(NY)Yes; No

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