The Interventions domains in SDTM capture investigational, therapeutic, and othertreatmentsthat 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 drugsare 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 aSubstance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions used fornon-medical purposes andoften maybe harmful to the individual or others.These includealcohol, 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 SDTMConcomitant/Prior Medications (CM) domain andinterventions 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 recreational product usage may be collected in studies.
Example
This example collects data on all types of recreational products used by subjects. 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.
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
1
What is the category of the substance used?
Substance Use Category
Record the recreational product category, if not pre-printed on the CRF.
Text
SUCAT
RECREATIONAL PRODUCT
2
Were any recreational products used?
Any Recreational Product Used
Indicate if the subject had used any recreational products.
Text
SUYN
SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT" where SUYN = "Not Done"
(NY)
Yes; No; Not Done
3
What was the reason the recreational product use was not done?
Reason Not Done
Record the reason recreational product use was not done.
Text
SUREASND
SUREASND
Section 2 The metadata/specification in the second section focus on each recreational product used.
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
4
What was the recreational product used?
Type of Recreational Product Used
Record each recreational product used on a new line.
Text
SUTRT
Alcohol;Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
5
Does the subject currently use or formerly used recreational products?
Usage
Check the appropriate box to indicate if the subject currently or formerly used recreational products.
Text
SUNCF
SUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP
(NCF)
FORMERLY:CURRENT;
6
What was the amount of the recreational product used?
Amount
Indicate the amount of recreational drug the subject consumes on a regular basis.
Text
SUDOSE; SUDOSTXT
7
SUDOSU
What was the unit?
Record the unit. See the protocol for a list of units.
Text
SUDOSU
SUDOSU
(UNIT)
8
SUDOSFRQ
What was the frequency of recreational product use?
Record how often the subject regularly uses the recreational product.
Text
SUDOSFRQ
(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
1
1234
SU
1234005
1
CIGARETTES
RECREATIONAL PRODUCT
Y
2
PACK
QD
BEFORE
2006-01-01
ONGOING
2006-01-01
2
1234
SU
1234005
2
MARIJUNA
RECREATIONAL PRODUCT
Y
2002
2006-01-01
3
1234
SU
1234006
1
CIGARETTES
RECREATIONAL PRODUCT
Y
1
PACK
QD
2003
BEFORE
2006-03-15
4
1234
SU
1234007
1
RECREATIONAL PRODUCT
RECREATIONAL PRODUCT
NOT DONE
Subject 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
Order
Question Text
Prompt
CRF Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instuctions
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
1
What is the object?
Text
FAOBJ
FAOBJ
TOBACCO
2
What was the age of the subject when they started smoking?
Age Started Smoking
Record the Age Category when the subject started smoking
Text
AGESTSMK__FAORRES
FAORRES
FAORRES WHERE FATESTCD = "AGESTSMK" and FAOBJ = "TOBACCO"
16-24 years; 25-34 years; 45–64 years; 65 years and older
3
Did the subject have any tobacco cessation counseling?
Tobacco Cessation Counseling
Indicate whether the subject had previous tobacco cessation counseling
Text
TBCESSCO__FAORRES
FAORRES
FAORRES WHERE FATESTCD = "TBCESSCO" and FAOBJ = "TOBACCO"
(NY)
No;Yes
4
What is the longest duration of previous abstinence from tobacco use?
Longest Duration of Abstinence
Record the longest duration of tobacco abstinence
Text
LDURABS__FAORRES
FAORRES
FAORRES WHERE FATESTCD = "LDURABS" and FAOBJ = "TOBACCO"
≤7 days; 8–28 days;1–6 months; >6 months
Section 2
Order
Question Text
Prompt
CRF Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instuctions
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
5
What is the type of tobacco product used by the subject?
Record the brand name of the tobacco product used.
Text
SUTRT
SUTRT
7
Is this the subject's usual brand of tobacco product?
Substance Use Subcategory
Indicate if this is the subject's usual brand of tobacco product used
Text
SUSCAT
SUSCAT
USUAL BRAND;
NOT USUAL BRAND
9
What was the duration of use of the tobacco product ?
Duration
Provide the duration for the product used
Text
SUCDUR
SUDUR
9
What was the unit of duration of use of the tobacco product?
Unit
Select the appropriate duration unit for the product used
Text
SUCDURU
SUDUR
DAYS; MONTHS; YEARS;
10
Is the tobacco use ongoing?
Ongoing
Record 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.
Text
SUONGO
SUENRF; SUENRTPT
SUENRF or SUENRTPT
(NY)
No;Yes
11
What was the end date?
End Date
Record 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.
Date
SUENDAT
SUENDTC
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Example
In this example, the sponsor collected information on previous medically recognized products used to reducenicotine dependency. The sposnor only collected details on the last attempt to reducenicotine dependencyfor each type of product used. . These products are represented in the Concomitant Medication (CM) domain.
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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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xx.xpt
Row
STUDYID
DOMAIN
USUBJID
CMSEQ
CMTRT
CMCAT
CMSCAT
CMPRESP
CMOCCUR
CMDTC
CMDUR
1
1234
CM
1234005
1
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-08-08
2
1234
CM
1234005
2
NICOTINE PATCH XYZ
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P2M
3
1234
CM
1234006
1
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-11-12
4
1234
CM
1234006
2
NICOTINE GUM ABC
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P3M
5
1234
CM
1234006
3
NICOTINE LOZENGES ABC
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P2W
6
1234
CM
1234006
1
BUPROPION
DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
LAST ATTEMPTED USE WITH THIS MEDICATION
P1M
7
1234
CM
1234007
2
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-06-12
8
1234
CM
1234007
3
VARENICLINE
DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
LAST ATTEMPTED USE WITH THIS MEDICATION
P40D
9
1234
CM
1234012
1
DRUG USED IN NICOTINE DEPENDENCE
Y
N
2008-03-05
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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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Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATESTCD
FATEST
FAOBJ
FACAT
FAORRES
FASTRESC
FADTC
1
1234
FA
1234005
1
TOTNUM
Total Number
DRUG USED IN NICOTINE DEPENDENCE
ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
4
4
2008-08-08
2
1234
FA
1234006
1
TOTNUM
Total Number
DRUG USED IN NICOTINE DEPENDENCE
ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
5
5
2008-11-12
3
1234
FA
1234007
1
TOTNUM
Total Number
DRUG USED IN NICOTINE DEPENDENCE
ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
3
3
2008-06-12
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Example
This example is another example of data collected on the use of smoking cessation products. This examples 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
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
1
What is the category for the medication?
Concomitant Medication Category
Text
CMCAT
SMOKING CESSATION PRODUCT
2
Were 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.
Text
CMOCCUR
CMOCCUR;
(NY)
No;Yes
Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.
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
3
What was the smoking cessation product used?
Smoking Cessation Product
Select the smoking cessation product.
Text
CMTRT
CMTRT
CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.
Did the subject previously use the selected medication/product for smoking cessation?
Smoking Cessation Product Used
Indicate if the subject had used the selected smoking cessation product
Text
CMOCCUR
CMOCCUR
(NY)
No; Yes
5
What was the name of the other smoking cessation product used?
Smoking Cessation Product Other
Indicate the Other type of product previously used.
Text
CMTRTO
CMTRT
6
Was the smoking cessation product discontinued due to an adverse experience?
Reason Smoking Cessation Product Discontinued
Indicate if the product was discontinued due to an Adverse Experience
Text
CMRSDISC
CMRSDISC
If Yes then CMRSDISC = "ADVERSE EXPERIENCE"
(NY)
No:Yes:
7
What 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.
Date
CMENDAT
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.
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