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The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product  coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).

Recreational drugs are chemical substances taken for enjoyment, or leisure purposes, rather than for medical reasons. They are often drugs that are misused or abused or drugs self-administered by the subject. To support standardization, CDISC defined a Substance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions used for non-medical purposes and often maybe harmful to the individual or others. These include alcohol, marijuana and tobacco.  

Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as concomitant medications and represented in the SDTM Concomitant/Prior Medications (CM) domain and interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains.

In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.  

Several examples are provided below to illustrate the different ways the subjects's history of recreational product usage may be collected in studies. 

Example

This example collects data on all types of recreational products previosuly used by the subject. The sponsor only collected the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.  

There are 2 sections of this example CRF: The questions in the first section focus on the whether any recreational products were used, and the questions in the second section are for each recreational product used. The applicant did not include subjects that did not use recreational products in the SDTM dataset. In order to save space, some of the permissible values are only shown in the metadata specifications. 


Section 1 The metadata/specification in the first section focus on the whether any recreational products were used. 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category of the substance used?Substance Use CategoryRecord the recreational product category, if not pre-printed on the CRF.TextSUCAT


RECREATIONAL PRODUCT 
2Were any recreational products used?Any Recreational Product UsedIndicate if the subject had used any recreational products.TextSUYN
SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT"  where SUYN = "Not Done"  (NY)Yes; No; Not Done
3What was the reason the recreational product use was not done?  Reason Not DoneRecord the reason recreational  product use was not done. TextSUREASNDSUREASND 



 

Section 2 The metadata/specification in the second section focus on each recreational product used. 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
4What was the recreational product used?Type of Recreational Product UsedRecord each recreational product used on a new line. TextSUTRT


Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other 



5Does the subject currently use or formerly used recreational products?UsageCheck the appropriate box to indicate if the subject currently or formerly used recreational products.TextSUNCFSUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP

(NCF)FORMERLY:CURRENT;
6What was the amount of the recreational product used?AmountIndicate the amount of recreational drug the subject consumes on a regular basis.TextSUDOSE; SUDOSTXT




7SUDOSUWhat was the unit?Record the unit. See the protocol for a list of units.TextSUDOSUSUDOSU(UNIT)


8SUDOSFRQWhat was the frequency of recreational product use?Record how often the subject regularly uses the recreational product.TextSUDOSFRQ
(FREQ)
Occasionally; Intermittent; Daily; PRN; Unknown

This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.   

Row 1:Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF.
Row 2:Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. SUPRESP is used to indicate that the use of marijuana was solicited on the CRF.
Row 3:Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:Shows the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.
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Row

STUDYID

DOMAIN

USUBJID

SUSEQ

SUTRT

SUCAT

SUPRESP

SUSTAT

SUREASND

SUDOSE

SUDOSU

SUDOSFRQ

SUSTDTC

SUENDTC

SUSTRTPT

SUSTTPT

SUENRTPT

SUENTPT

11234SU12340051CIGARETTESRECREATIONAL PRODUCTY

2PACKQD

BEFORE2006-01-01ONGOING2006-01-01
21234SU12340052MARIJUNA RECREATIONAL PRODUCTY




2002 2006-01-01



31234SU12340061CIGARETTESRECREATIONAL PRODUCTY

1PACKQD
2003BEFORE2006-03-15

41234SU12340071RECREATIONAL PRODUCTRECREATIONAL PRODUCT
NOT DONESubject left office before CRF was completed








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Example

This example illustrates how tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapy for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips. The specific brand name of the product was collected. The sponsor collected whether the product was still being used, and if not the end date of usage. Usage of these products are represented in the SU domain.  

Section 1 

OrderQuestion TextPromptCRF Completion InstructionsTypeCollection Variable Tabulation Target Mapping InstuctionsControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What is the object? 

TextFAOBJFAOBJ


TOBACCO
2What was the age of the subject when they started smoking?  Age Started SmokingRecord the Age Category when the subject started smokingTextAGESTSMK__FAORRESFAORRESFAORRES WHERE FATESTCD = "AGESTSMK"  and FAOBJ = "TOBACCO"
16-24 years; 25-34 years; 45–64 years; 65 years and older
3Did the subject have any tobacco cessation counseling?Tobacco Cessation Counseling Indicate whether the subject had previous tobacco cessation counselingTextTBCESSCO__FAORRESFAORRESFAORRES WHERE FATESTCD = "TBCESSCO" and FAOBJ = "TOBACCO"(NY) No;Yes
4What is the longest duration of previous abstinence from tobacco use? Longest Duration of  AbstinenceRecord the longest duration of tobacco abstinenceTextLDURABS__FAORRESFAORRESFAORRES WHERE FATESTCD = "LDURABS"  and FAOBJ = "TOBACCO" 
≤7 days; 8–28 days;1–6 months;  >6 months 

Section 2 

OrderQuestion TextPromptCRF Completion InstructionsTypeCollection Variable Tabulation Target Mapping InstuctionsControlled Terminology Code List NamePermissible ValuesPre-Populated Value
5What is the type of tobacco product used by the subject? Substance Use CategoryRecord the type of tobacco product used.TextSUCATSUCAT

SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT) 


6What was the brand name of the tobacco product? 

Product Name Record the brand name of the tobacco product used.  TextSUTRTSUTRT



7Is this the subject's usual brand of tobacco product? Substance Use Subcategory   Indicate if this is the subject's usual brand of tobacco product usedTextSUSCATSUSCAT


USUAL BRAND; 

NOT USUAL BRAND


9What was the duration of use of the tobacco product ?  DurationProvide the duration for the product usedTextSUCDURSUDUR



9What was the unit of duration of use of the tobacco product?UnitSelect the appropriate duration unit for the  product usedTextSUCDURUSUDUR

DAYS; MONTHS; YEARS;
10Is the tobacco use ongoing?OngoingRecord the product used as ongoing if the subject has not stopped taking the  product used at the time of data collection. The end date should be left blank.TextSUONGOSUENRF;  SUENRTPTSUENRF or SUENRTPT(NY)No;Yes
11What was the end date?End DateRecord the date the  product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the product used leave this field blank.DateSUENDATSUENDTC



The example SDTM datasets used to represent the collected data are shown below. 

SUTRT represents the brand name of the tobacco product. The applicant added the UPC code of the product to the dataset. Some applicants may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The applicant used the first visit date to populate SUSTPT and SUENTPT.          

Row 1:Shows that the subject used the tobacco product shown in SUTRT. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing,
Row 2:Shows that the subject used smokeless tobacco product shown in SUTRT. This was not the subject's usual brand of smokeless tobacco product.
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Row

STUDYID

DOMAIN

USUBJID

SUSEQ

SUTRT

SUCAT

SUSCAT

SUDUR

SUENDTC

SUSTRTPT

SUSTTPT

SUENRTPT

SUENTPT

1TB901SUTB9010051XYZ Menthol King SizeSMOKED TOBACCO PRODUCTUSUAL BRANDP20Y
BEFORE2006-01-01ONGOING2006-01-01
2TB901SUTB9010062AAA Chewing TobaccoSMOKELESS TOBACCO PRODUCTNOT USUAL BRANDP3M2006-01-01BEFORE2006-01-01

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The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO".  Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.  

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RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFAORRESFAORRESUFASTRESCFASTRESNFASTRESUVISITNUMFADTC
1TB901FATB901005

1

AGESTSMKAge Started SmokingTOBACCO16-24Years16-24
Years12006-01-01
2TB901FATB901005

2

TBCESSCOTobacco Cessation CounselingTOBACCON
N

12006-01-01
3TB901FATB901005

3

LDURABSLongest Duration of AbstinenceTOBACCO>6 months
>6 months

12006-01-01
4TB901FATB9010054UPCCODEUPC CodeXYZ Menthol King Size974411001532
974411001532974411001532
12006-01-01
5TB901FATB9010055UPCCODEUPC CodeAAA Chewing Tobacco974411001532
974411001532974411001532
12006-01-01
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Example

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What was the medically recognized product name? Medication
TextCMTRTCCMTRT


DRUG USED IN  NICOTINE DEPENDENCE
2
Pre-Specified Intervention
TextCMPRESPCMPRESP


Y
3Did the subject previously use medically recognized products to reduce nicotine dependency?Any Medically Rrecognized Products Taken For Nicotine DependencyIndicate if the subject had used any medically recognized products to attempt to reduce nicotine dependencyTextCMOCCURCMOCCUR
(NY)No;Yes;Not Done
4How many times did the subject attempt to use use medically recognized products to reduce nicotine dependencyTimes the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use medically recognized products to reduce nicotine dependencyTextFAORRESFAORRESFAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "


5
Category
TextFACAT FACAT


ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
6What is the category of the medication/product the subject used to attempt to reduce nicotine dependency? Medication
TextCMTRTCMCAT



NICOTINE REPLACEMENT THERAPY: NOT A NRT
7What is the medication/product subcategory, if not pre-printed on the CRF.SubcategoryApplicant DefinedTextCMSCATCMSCAT


LAST ATTEMPTED USE WITH THIS MEDICATION
8What was the name of the medication/product the subject used to reduce nicotine dependency

 MedicationRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.TextCMTRTCMTRT



9What was the duration of the medication/product used to reduce nicotine dependency for the last attempt?Collected DurationProvide the duration of the medication/product used. TextCMCDURCMDUR



10What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt?Collected Duration UnitSelect the appropriate duration unit of the medication/product used.TextCMCDURUCMDUR
(UNIT)DAYS; MONTHS; YEARS

These example SDTM datasets represent the data collected on the above CRF.
Rows 1, 3, 7, 9:Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary.
Rows 2, 4, 5, 6, 8:Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMPRESPCMOCCURCMDTCCMDUR
11234CM12340051DRUG USED IN NICOTINE DEPENDENCE

YY2008-08-08
21234CM12340052NICOTINE PATCH XYZNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2M
31234CM12340061DRUG USED IN NICOTINE DEPENDENCE

YY2008-11-12
41234CM12340062NICOTINE GUM ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P3M
51234CM12340063NICOTINE LOZENGES ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2W
61234CM12340061BUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

YY2008-06-12
81234CM12340073VARENICLINEDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

YN2008-03-05
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FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

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RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTC
11234FA12340051TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE442008-08-08
21234FA12340061TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE552008-11-12
31234FA12340071TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE332008-06-12
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Example

This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit.  This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.  

 

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. 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 is the category for the medication?Concomitant Medication Category
TextCMCAT



SMOKING CESSATION PRODUCT
2Were any smoking cessation products taken?Any Smoking Cessation Products Taken Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.TextCMOCCURCMOCCUR; 
(NY)No;Yes
Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
3What was the smoking cessation product used?Smoking Cessation ProductSelect the smoking cessation product.TextCMTRTCMTRTCMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    


NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4

Did the subject previously use the selected medication/product for smoking cessation?

Smoking Cessation Product UsedIndicate if the subject had used the selected smoking cessation productTextCMOCCURCMOCCUR
(NY)No; Yes
5

What was the name of the other smoking cessation product used? 

Smoking Cessation Product OtherIndicate the Other type of product previously used. TextCMTRTOCMTRT



6Was the smoking cessation product discontinued due to an adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to an Adverse ExperienceTextCMRSDISCCMRSDISCIf Yes then CMRSDISC = "ADVERSE EXPERIENCE"(NY)No:Yes:
7What was the last date the product was used? Last Date Smoking Cessation Product Used Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded. DateCMENDAT CMENDTC



This is the SDTM date for the data collected above. In this example, the applicant only represented whether the product was used in the last 14 days. CMPRESP was populated by the applicant for all pre-specified products. Medication specified as "OTHER" were not considered prespecified.   
Row 1:Shows the subject reported they had not previously used any smoking cessation product ( CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF.
Rows 2, 5, 8, 11, 14, 17:Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF.
Rows 3, 6, 9, 12, 15, 18:Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified.
Rows 4, 7, 10, 13, 16:Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. Subject ABC-0006 discontinued BUPROPION for an adverse event.
Row 19:Shows the subject used natural supplement ABC for smoking cessation. Since this product was not specified on the CRF, CMPRESP is null.

Row Captions Debug Message

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMPRESPCMOCCURCMRSDISCCMDTCCMENDTC
1ABCCMABC-00011SMOKING CESSATION PRODUCT
YN
2020-01-05
2ABCCMABC-00021SMOKING CESSATION PRODUCT
YY
2020-02-15
3ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-02-15
4ABCCMABC-00023NICOTINE GUMSMOKING CESSATION PRODUCTYY
2020-02-152020-02-02
5ABCCMABC-00031SMOKING CESSATION PRODUCT
YY
2020-04-15
6ABCCMABC-00032NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-04-15
7ABCCMABC-00033NICOTINE LOZENGESMOKING CESSATION PRODUCTYY
2020-04-152012
8ABCCMABC-00041SMOKING CESSATION PRODUCT
YY
2021-04-16
9ABCCMABC-00042NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-04-16
10ABCCMABC-00043NICOTINE INHALERSMOKING CESSATION PRODUCTYY
2021-04-162021-01
11ABCCMABC-00051SMOKING CESSATION PRODUCT
YY
2020-09-24
12ABCCMABC-00052NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-09-24
13ABCCMABC-00053VARENICLINESMOKING CESSATION PRODUCTYY
2020-09-242020-08-07
14ABCCMABC-00061SMOKING CESSATION PRODUCT
YY
2021-04-16
15ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2021-04-16
16ABCCMABC-00063BUPROPIONSMOKING CESSATION PRODUCTYYADVERSE EVENT2021-04-162020-01-09
17ABCCMABC-00071SMOKING CESSATION PRODUCT
YY
2020-07-10
18ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-07-10
19ABCCMABC-00072NATURAL SUPPLEMENT ABCSMOKING CESSATION PRODUCT
Y
2020-07-102020-04-10
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