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. .
...
| 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 medicationproduct? | 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 the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of of smoking cessation products product previously used. | Text | CMTRT |
|
|
|
|
|
|
| | 4 | CMCRSDIS | Was the smoking cessation products 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 |
|
|
|
|
|
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Shows the subject reported they had not previously used any smoking cessation product. | | 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 | 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 3: | Shows 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 2020-02-12. CMENRTPT indicates the usage ended prior to the date in CMENTPT. | | Rows 4-6: | Show the subject that used these products. The subject discontinued Zyban for an adverse event. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMOCCOR | CMPRESP | CMRSDISC | CMDTC | CMENDTC | CMENTPT | CMENRTPT |
|---|
| 1 | ABC | CM | XYZ-0001 | 1 | SMOKING CESSATION PRODUCT |
| N |
|
| 2020-01-05 |
|
|
| | 2 | ABC | CM | ABC-0001 | 32 | NICOTINE GUM | SMOKING CESSATION PRODUCT |
| Y |
| 2020-02-15 | 2020-02-02/2003-02-15 |
|
| | 3 | ABC | CM | ABC-0001 | 43 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT |
| Y |
| 2020-02-15 |
| 2020-02-12 | PRIOR | | 4 | ABC | CM | ABC-0003 | 1 | NICOTINE INHALER | SMOKING CESSATION PRODUCT |
| Y |
| 2021-04-16 | 2004-01-07 |
|
| | 5 | ABC | CM | ABC-0003 | 2 | Chantix | SMOKING CESSATION PRODUCT |
| Y |
| 2021-04-16 | 2004-01-07 |
|
| | 6 | ABC | CM | ABC-0003 | 3 | Zyban | SMOKING CESSATION PRODUCT |
| Y | ADVERSE EVENT | 2021-04-16 | 2004-01-09 |
|
|
|
|