This is an example CRF used to collect information on prior use of smoking cessation products. The specific type of non-pharmaceutical smoking cessation product was not of interest. The reason why a product was discontinued and any use in the last 14 days was of interest. .
Indicate if the subject took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF.
Were any smoking cessation products taken?
CMYNNot Submitted
<NY codelist>
Check all the Smoking Cessation Products previously used. Cessation product used. For each product previously complete the following i
What was the Smoking Cessation medication?
CMTRT(n)CMTRT
CMTRTOTCMTRT
_________________
Order
CDASH Variable
Question Text
Prompt
CRF Completion Instructions
Type
SDTMIG Target
SDTMIG Target Mapping
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
Query Display
List Style
Hidden
2
CMYN
Were any smoking cessation products taken?
Any Smoking Cessation Products
Indicate if the subject took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF.
Text
N/A
(NY)
Yes; No
4
CMTRT(n)
What was the Smoking Cessation medication?
Smoking Cessation Product
Check all the Smoking Cessation Products previously used. Cessation product used. For each product previously complete the following i
What was the name of the other smoking cessation product used?
Text
CMTRT
CMCAT
Hidden/pre-populated
SMOKING CESSATION PRODUCT
Indicate if the smoking cessation product was discontinued due to a Adverse Event
Was the smoking cessation products discontinued due to a adverse event ?
CMCRSDISIf Yes then CMRSDISC = "ADVERSE EVENT"
<NY codelist>
Was the product used in the last 14 days :
CMENDTC
For each product previously taken record the appropriate details below.
Order
CDASH Variable
Question Text
Prompt
CRF Completion Instructions
Type
SDTMIG Target
SDTMIG Target Mapping
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
Query Display
List Style
Hidden
1
CMCAT
What is the category for the medication?
Concomitant Medication Category
Record the medication category, if not pre-printed on the CRF.
Text
CMCAT
SMOKING CESSATION PRODUCT
Yes
2
CMCRSDIS
Was the smoking cessation products discontinued due to a adverse event ?
Reason Smoking Cessation Product Discontinued
Indicate if the smoking cessation product was discontinued due to a Adverse Event
Text
CMRSDISC
If Yes then CMRSDISC = "ADVERSE EVENT"
(NY)
Yes; No
3
CMENDTC
Was the product used in the last 14 days :
CMENDTC
Yes, No
Represent that end sometime between the date of collection , and 14 days prior IF DTC = 2020-02-15 then ENDTC= (e.g 2020-02-02/2003-02-15 )
Rows 1,4-6 :
The subject reported that they had not previously used the specified smoking cessation product.
Row 3:
The subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended 14 prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case i2020-02-12. CMENRTPT indicates the usage ended prior to the date in CMENTPT. .
Row 4
The subject reported using Nicotine Gum. This gum was used within 14 days of the date of collection. Since, the last date of use is not known CMENDTC describe the beginning and the end of the interval of uncertainty. The dates are separate them with a solidus, as shown in the following table.
Row Captions Debug Message
Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.
cm.xpt
cm.xpt
Row
STUDYID
DOMAIN
USUBJID
CMSEQ
CMTRT
CMOCCOR
CMDTC
CMENDTC
CMENTPT
CMENRTPT
1
ABC
CM
ABC-0001
1
NICOTINE PATCH
N
2020-02-15
2
ABC
CM
ABC-0001
2
NICOTINE GUM
Y
2020-02-15
2020-02-02/2003-02-15
3
ABC
CM
ABC-0001
3
NICOTINE LO
Y
2020-02-15
2020-02-12
PRIOR
4
ABC
CM
ABC-0001
4
NICOTINE INHALER
N
2020-02-15
2004-01-07
5
ABC
CM
ABC-0001
5
Chantix
N
2020-02-15
2004-01-07
6
ABC
CM
ABC-0001
6
Zyban
N
2020-02-15
2004-01-09
Dataset Debug Messages
There is a leading, trailing, or non-breaking space in the dataset.