This is an example CRF used to collect routine safety labs that are often collected in tobacco studies.
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HEMATOLOGY; CLINICAL CHEMISTRY URINALYSIS
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This is an example of the SDTM LB dataset used to represent rotine routine safety laboratory tests.
The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the Logical Observation Identifiers Names and Codes ( LOINC ) database that identifies a specific laboratory test. were included by the sponsor. The LOINC to LB Mapping Codetable , (available at https://www.cdisc.org/standards/terminology/controlled-terminology, may ) may be used to identify appropriate CDISC CT values for a test with a particular LOINC code.
LBNRIND was added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. LBSTNRC was used to populated a normal range values that are character values for an ordinal scale (e.g., “NEGATIVE") . LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI are null for these types of tests.
| Dataset wrap |
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-283 |
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| Rowcaps |
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| Rows 1-4: | Show records for common tests to evaluate hematogolyhematology. The sponsor applicant used LBCAT (HEMATOLOGY) to group these tests. | | Rows 2-3: | Show 2 records for alkaline phosphatase done at the same visit, a day apart. LBPTFL is set to "Y" for both rows because each result is based on a sample from a single point in time. | Rows 5, 7, 8: | Show records for common test under the grouping CLINICAL CHEMSITRY.tests. LBCAT indicates the category assigned for these laboratory tests. | | Row 6: | Shows a value collected in 1 unit , but converted to selected standard unit. | | Row 9: | Shows use of LBSTNRC for Cannabinoids cannabinoids that is not reported as a continuous numeric result. The result was evaluated by the investigator and determined to be clinically significant |
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| Dataset2 |
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ROW | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRC | LBSTNRLO | LBSTNRHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | LBCLSIG | VISITNUM | LBDTC |
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| 1 | TBLB001 | LB | 001-001 | 1 | WBC | Leukocytes | HEMATOLOGY | 11.0 | 10^9/L | 4.5 | 11.0 | 11.0 | 11.0 | 10^9/L |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y |
| 1 | 2020-12-01 | | 2 | TBLB001 | LB | 001-001 | 2 | RBC | RBC | HEMATOLOGY | 5.4 | 10^12/L | 4.7 | 6.1 | 5.4 | 5.4 | 10^12/L |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y |
| 1 | 2020-12-01 | | 3 | TBLB001 | LB | 001-001 | 3 | PLAT | Platelets | HEMATOLOGY | 158 | 10^9/L | 150 | 400 | 158 | 158 | 10^9/L |
| 150 | 400 |
| 49497-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 4 | TBLB001 | LB | 001-001 | 4 | HGB | Hemoglobin | HEMATOLOGY | 14.5 | g/dL | 14 | 18 | 14.5 | 14.5 | g/dL |
| 14 | 18 |
| 718-7 | BLOOD | Y |
| 1 | 2020-12-01 | | 5 | TBLB001 | LB | 001-001 | 5 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 200 |
| 229 | 229 | mg/dL |
| 200 |
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| 2093-3 | BLOOD | Y |
| 1 | 2020-12-01 | | 6 | TBLB001 | LB | 001-001 | 6 | ALB | Albumin | CLINICAL CHEMISTRY | 40.0 | g/L | 34 | 54 | 4.0 | 4.0 | g/dL |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 7 | TBLB001 | LB | 001-001 | 7 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.8 | mg/dL | 0.7 | 1.3 | 0.8 | 0.8 | mg/dl |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y |
| 1 | 2020-12-01 | | 8 | TBLB001 | LB | 001-001 | 8 | SPGRAV | Specific Gravity | URINALYSIS | 1.002 |
| 1.005 | 1.030 |
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| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2020-12-01 | | 9 | TBLB001 | LB | 001-001 | 9 | CANNAB | Cannabinoids | DRUG TOXICITY | POSITIVE |
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| POSITIVE |
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| POSITIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2020-12-01 |
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