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 the SDTM date for the data collected above. In this example, the applicant only represented whether the product was used in the last 14 days was of interest. .
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For each product previously taken record the appropriate details below.
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Nicotine Patches; Nicotine Gum; Nicotine Lozenge; Nicotine Inhaler; Chantix; Zyban ; Other
. CMPRESP was populated by the applicant for all pre-specified products. Medication specified as "OTHER" were not considered prespecified.
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| Row 1: | Shows the subject reported they had not previously used any smoking cessation product ( CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF. | | Rows 2, 5, 8, 11, 14, 17: | Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF. | | Rows 3, 6, 9, 12, 15, 18: | Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified. | | Rows 4, 7, 10, 13, 16: | Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. Subject ABC-0006 discontinued BUPROPION for an adverse event. | | Row 19: | Shows the subject used natural supplement ABC for smoking cessation. Since this product was not specified on the CRF, CMPRESP is null. |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMPRESP | CMOCCUR | CMRSDISC | CMDTC | CMENDTC |
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| 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 |
| 2020-02-15 |
| | 3 | ABC | CM | ABC-0002 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-02-15 |
| | 4 | ABC | CM | ABC-0002 | 3 | NICOTINE GUM | SMOKING CESSATION PRODUCT | Y | Y |
| 2020-02-15 | 2020-02-02 | | 5 | ABC | CM | ABC-0003 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-04-15 |
| | 6 | ABC | CM | ABC-0003 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-04-15 |
| | 7 | ABC | CM | ABC-0003 | 3 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT | Y | Y |
| 2020-04-15 | 2012 | | 8 | ABC | CM | ABC-0004 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 9 | ABC | CM | ABC-0004 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-04-16 |
| | 10 | ABC | CM | ABC-0004 | 3 | NICOTINE INHALER | SMOKING CESSATION PRODUCT | Y | Y |
| 2021-04-16 | 2021-01 | | 11 | ABC | CM | ABC-0005 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-09-24 |
| | 12 | ABC | CM | ABC-0005 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-09-24 |
| | 13 | ABC | CM | ABC-0005 | 3 | VARENICLINE | SMOKING CESSATION PRODUCT | Y | Y |
| 2020-09-24 | 2020-08-07 | | 14 | ABC | CM | ABC-0006 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 15 | ABC | CM | ABC-0002 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2021-04-16 |
| | 16 | ABC | CM | ABC-0006 | 3 | BUPROPION | SMOKING CESSATION PRODUCT | Y | Y | ADVERSE EVENT | 2021-04-16 | 2020-01-09 | | 17 | ABC | CM | ABC-0007 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-07-10 |
| | 18 | ABC | CM | ABC-0002 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-07-10 |
| | 19 | ABC | CM | ABC-0007 | 2 | NATURAL SUPPLEMENT ABC | SMOKING CESSATION PRODUCT |
| Y |
| 2020-07-10 | 2020-04-10 |
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Thsi is the SDTM date for the date collected above.
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| 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 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMOCCOR | CMDTC | CMENDTC | CMENTPT | CMENRTPT |
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| 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 |
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