This is an example CRF used to collect routine safety laboratory 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 preprinted 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.
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| title | CDASH LB Metadata Specifications |
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| Metadataspec |
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Section 1 CRF | Case Report Form Completion Instructions |
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CDASH Name SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 | What was the name of the |
lab panelLab Panel | Laboratory Name | Record the |
lab test category, if not pre-printed on the CRF.LBCAT | LBCAT | HEMATOLOGY; CLINICAL CHEMISTRY; URINALYSIS| laboratory name | Text | LBNAM | LBNAM |
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| | 2 | Was the lab performed? | Lab Performed | Indicate whether or not lab specimen was collected, or measurement performed. | Text | LBPERF | LBSTAT | LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y" | (NY) | Yes; No |
| | 3 | What was the date of the lab specimen collection? | Specimen Collection Date | Record the date of specimen collection |
using this format (DD-MON-YYYY)| . | Date | LBDAT | LBDTC |
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| | 4 | What was the |
name laboratory usedLaboratory Name | Record the laboratory name. | LBNAM | LBNAM | 5 | | Specimen Collection Time | Record time of collection (as complete as possible). | Time | LBTIM | LBDTC |
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| | 5 | Was the subject fasting? | Fasting | Record whether the subject was fasting prior to the test being performed | Text | LBFAST | LBFAST |
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Section 2 | Metadataspec |
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| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 6 | What is the lab test name? | Lab Test Name | Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the |
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sponsor | applicant may provide additional instructions to ensure the data is entered as intended. | Text | LBTEST | LBTEST; LBTESTCD | LBTEST and LBTESTCD | (LBTEST) | WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine |
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| | 7 | What was the result of the lab test? | Result | Record laboratory test result. | Text | LBORRES | LBORRES |
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| | 8 | What was the unit of the lab result? | Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | LBORRESU | LBORRESU |
| (UNIT) | g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO |
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| | 9 | What was the lower limit of the reference range for this lab test? | Normal Range Lower Limit | Record the lower limit of the reference range of the lab test. | Text | LBORNRLO | LBORNRLO |
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| | 10 | What was the high limit of the reference range for this lab test? | Normal Range Upper Limit | Record the upper limit of the reference range of the lab test. | Text | LBORNRHI | LBORNRHI |
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10 | How do the reported values compare within the reference range? | Comparison to Reference Range | Record where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW). | LBNRIND | LBNRIND | (NRIND) | High; Normal; Low |
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| | 11 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | Text | LBCLSIG | LBCLSIG |
| (NY) | Yes; No |
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