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 | 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.
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 |
| 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. | Text | CMTRT |
|
| NICOTINE PATCHE; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; 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 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.
Dataset wrap |
---|
|
Rowcaps |
---|
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. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMPRESP | CMOCCUR | CMRSDISC | CMDTC | CMENDTC | CMENRTPT | CMENTPT |
---|
1 | ABC | CM | ABC-0001 | 1 | SMOKING CESSATION PRODUCT |
| Y | N |
| 2020-01-05 |
|
|
| 2 | ABC | CM | ABC-0002 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-01-05 |
|
|
| 3 | ABC | CM | ABC-0002 | 2 | NICOTINE GUM | SMOKING CESSATION PRODUCT | Y |
|
| 2020-02-15 | 2020-02-02/2003-02-15 |
|
| 4 | ABC | CM | ABC-0003 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-04-15 |
|
|
| 5 | ABC | CM | ABC-0003 | 2 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT | Y |
|
| 2020-04-15 |
| PRIOR | 2020-04-02 | 6 | ABC | CM | ABC-0004 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
|
|
| 7 | ABC | CM | ABC-0004 | 2 | NICOTINE INHALER | SMOKING CESSATION PRODUCT | Y |
|
| 2021-04-16 | 2021-01-07 |
|
| 8 | ABC | CM | ABC-0005 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-09-24 |
|
|
| 9 | ABC | CM | ABC-0005 | 2 | VARENICLINE | SMOKING CESSATION PRODUCT | Y |
|
| 2020-09-24 | 2020-08-07 |
|
| 10 | ABC | CM | ABC-0006 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
|
|
| 11 | ABC | CM | ABC-0006 | 2 | BUPROPION | SMOKING CESSATION PRODUCT | Y |
| ADVERSE EVENT | 2021-04-16 | 2020-01-09 |
|
| 12 | ABC | CM | ABC-0007 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-07-10 |
|
|
| 13 | ABC | CM | ABC-0007 | 2 | BUPROPION | SMOKING CESSATION PRODUCT |
|
|
| 2020-07-10 | 2020-04-10 |
|
|
|
|