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 CM LB Metadata Specifications |
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| Metadataspec |
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Section 1 CDASH Variable Name CRF | Case Report Form Completion Instructions | Type |
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SDTMIG Target 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 |
is category the medication subject used to attempt to reduce nicotine dependency? Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | CMCAT | NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 | What was the name of the medication the subject used to reduce nicotine dependency? Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | 4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | DAYS; MONTHS; YEARS| laboratory used? | Laboratory Name | Record the 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 . | Date | LBDAT | LBDTC |
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| | 4 | What was the time of the lab specimen collection? | 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 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 |
| | 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 |
| | 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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| | 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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