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titleCDASH CM Metadata Specifications
Metadataspec

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;  

OrderCDASH Variable Name Question TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What is the category of the  medication the subject used to attempt to reduce nicotine dependencyMedication CategoryRecord the type of medicaiton the subject used to reduce nicotine dependency.SCPERFWere subject characteristics collected?Subject Characteristics CollectedIndicate if subject characteristics information was collectedIndicate if the subject experienced any medical conditions or events. If Yes, include record the appropriate details where indicated on the CRF.CMCAT.SCSTATIf SCPERF = "Y", NOT SUBMITTED. If SCPERF = "N", SCSTAT where SCTESTCD = "SCALL".(NY)Yes; No
2EDLEVEL_SCORRESWhat is the subject's education level?Education LevelIndicate the subject's education level.SCORRES;SCORRES WHERE SCTESTCD = "EDLEVEL"
Did not complete Secondary School or Less than High School; Some Secondary School or High School Education; High School or Secondary School Degree Complete; Associate’s or Technical Degree Complete; College or Baccalaureate Degree Complete; Doctoral or Postgraduate Education2What is the subcategory for the medication?Medication SubcategoryRecord the medication subcategory, if not pre-printed on the CRF.CMSCATLAST ATTEMPTED USE WITH THIS MEDICATION
3JOBCLAS_SCORRESWhat was the name of the medication the subject used to reduce nicotine dependency
 MedicationRecord only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name.Applicant-Defined CRF Completion InstructionsCMTRTis the subject’s employment status?Employment StatusIndicate the subject's employment status.SCORRESSCORRES WHERE SCTESTCD = "JOBCLAS"(EMPSTAT)Full-time; Part-time; Not employed
4INCOME_SCORRESWhat is the subject's income?Income Indicate the subject's  income.SCORRESSCORRES WHERE SCTESTCD = "INCOME"

<100% poverty guideline.;100-200% poverty guidelines; >200% poverty guidelines;


5MARISTAT_SCORRESWhat is the subject's marital status?Marital StatusIndicate the subject's marital status.SCORRESSCORRES WHERE SCTESTCD = "MARISTAT"(MARISTAT)Never Married; Married; Legally Separated; Divorced; Widowed
6NATORIG_SCORRESWhat is the subject's national origin status?National OriginIndicate the subject's national origin SCORRESSCORRES WHERE SCTESTCD = "NATORIG"


7MILTSTAT_SCORRESWhat is the subject’s military status ?Military StatusIndicate the subject's military status.SCORRESSCORRES WHERE SCTESTCD = "MILTSTAT"

NO MILITARY SEVICE;

ACTIVE SERVICE;

VETERAN;


8SECHNDTB_SCORRESWas the subject exposed  to second hand smoke ?Second Hand Smoke Exposure  Indicate the subject's exposure to second hand smoke SCORRESSCORRES WHERE SCTESTCD = "SECHNDTB"

No Exposure to Second Hand smoke; 

Exposure at Home only; 

Exposure at work only; 

Exposure at Work and Home; 


9AGESTSMK__SCORRESWhat was the age of the subject when they started smoking?  Age Started SmokingRecord the Age Category when the subject started smokingSCORRESSCORRES WHERE SCTESTCD = "AGESTSMK"
16-24 years; 25-34 years; 45–64 years; 65 years and older
10TBCESSCO__SCORRESDid the subject have any tobacco cessation counseling?Tobacco Cessation Counseling Indicate whether the subject had previous tobacco cessation counseling.SCORRESSCORRES WHERE SCTESTCD = "TBCESSCO"(NY)Yes; No
11LDURABS__SCORRESWhat is the longest duration of previous abstinence from tobacco use? Longest Duration of  AbstinenceRecord the longest duration of tobacco abstinenceSCORRESSCORRES WHERE SCTESTCD = "LDURABS"
≤7 days; 8–28 days;1–6 months;  >6 months 4What was the duration of the medication used to reduce nicotine dependency for the last attempt?  Collected DurationProvide 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.CMDUR5What was the duration unit of the medication used to reduce nicotine dependency for the last attempt Collected Duration UnitSelect the appropriate duration unit of the medication used. Record the start date of the medical event or condition using this format (DD-MON-YYYY).CMDURDAYS; MONTHS; YEARS