This is an example CRF used to collect information on prior use of smoking cessation products. 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?
CMOCCUR
<NY codelist>
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
CMOCCUR
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
CMOCCUR;
(NY)
Yes; No
For each product previously taken record the appropriate details below.
CMCAT
Hidden/pre-populated
SMOKING CESSATION PRODUCT
Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line.
What was the smoking cessation product?
CMTRT
Indicate the Other type of smoking cessation product previously used.
CMTRTOTCMTRT
_________________
Indicate if the smoking cessation product was discontinued due to a Adverse Event
Was the smoking cessation product discontinued due to a adverse event ?
CMCRSDISIf Yes then CMRSDISC = "ADVERSE EVENT"
<NY codelist>
Was the product used in the last 14 days?
CMENDTC
.
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
Text
CMCAT
SMOKING CESSATION PRODUCT
Yes
2
CMTRT
What was the smoking cessation product?
Smoking Cessation Product
Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line.
What was the name of the other smoking cessation product used?
Smoking Cessation Product Other
Indicate the Other type of smoking cessation product previously used.
Text
CMTRT
4
CMCRSDIS
Was the smoking cessation product 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
5
CMENDTC
Was the product used in the last 14 days?
CMENDTC
Yes; No
This is the SDTM date for the date collected above.
Row 1:
Shows the subject reported they had not previously used any smoking cessation product (e.g., CMOCCUR =N) . CMPRESP was include to indicate that the use of smoking cessation product was specifically asked.
Rows 2,4,6,8,10,12
Show the subjects reported they had previously used smoking cessation products.
Row 2:
Shows 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 separated with a solidus, as shown in the table. CMPRESP is used to repesent that this product was pre-specified.. CMOCCUR is null, since the sponsor did not directly ask on the CRF whether the product was taken. The investigator just checked which products were used.
Row 5:
Shows the subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended at least 14 days prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case 2020-04-01. CMENRTPT indicates the usage ended prior to the date in CMENTPT.
Rows 7,9,11
Show the subjects used the product shown in CMTRT. Subject ABC-0006 discontinued BUPROPION for an adverse event.
Row 13
Shows the subject used Bupropion for smoking cessation. Since, this product was not specifed on the CRF, CMPRESP is null.
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