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.
Example
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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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su.xpt
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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Dataset Wrapper Debug Message
Please add a row column to your dataset.
Example
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
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Example
This is an example of a clinical trial where the sponsor collected information on previous medically recognized products used to reducenicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.
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Example
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
Remember to keep number agreement between labels and captions.
