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. .
| Xformpusher |
|---|
| 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 | 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 |
|
|
|
|
|
For each product previously taken record the appropriate details below.
| Xformpusher |
|---|
| .
| 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 | CMTRT | What was the Smoking Cessation medication? | Smoking Cessation Product | Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line. | Text | CMTRT |
|
| Nicotine Patches; Nicotine Gum; Nicotine Lozenge; Nicotine Inhaler; Chantix; Zyban ; Other |
|
|
|
| | 3 | CMTRTOT | What was the name of the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of smoking cessation products previously used. | Text | CMTRT |
|
|
|
|
|
|
| | 4 | 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 |
|
|
|
| | 5 | CMENDTC | Was the product used in the last 14 days? |
|
|
| CMENDTC |
|
| Yes, No |
|
|
|
|
|
Thsi is the SDTM date for the date collected above.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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. |
|
| Dataset2 |
|---|
| 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 |
|
|
|
|