| Num | Figure(s) | Reference | Description |
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| 1 | Figure 1 | Reference period | - The reference period is defined as the timeframe between the reference start date for the subject and the reference end date for the subject. This reference period is chosen by the applicant according to the needs of the study and may vary. In Figure 1 the study reference period corresponds to the time between subjects' first and last exposure to a tobacco product, which is a typical scenario for a study reference period.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-430 |
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-588 |
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. This reference period (represented by the time between B and C) is part of the overall context of the study. - Observations about concomitant medications used by the subject with the timing of use are collected in relation to the study reference period:
- For A, the start and end dates for the concomitant medication are known and are collected.
- Collection fields CMSTDAT and CMENDAT are used to collect the start and end dates for the concomitant medication.
- For D, the start date for the concomitant medication is unknown and cannot be collected.
- Collection field CMPRIOR is used to collect that the known start of the concomitant medication relative to exposure is prior to the subject's first exposure.
- Collection field CMENDAT is used to collect the known end date.
- For E, the subject has not discontinued the concomitant medication and therefore the end date for the concomitant medication cannot be collected.
- Collection field CMSTDAT is used to collect the known start date.
- Collection field CMONGO is used to collect that the use of the concomitant medication is ongoing relative the subject's last exposure.
- The following variables are used to represent collected data in subsequent tabulation datasets:
- RFSTDTC and RFENDTC represent the dates of the subject's first and last exposure to the tobacco product (per Figure 1), respecticely, in the Demography (DM) dataset.
- CMSTRF and CMENRF represent values from collection variables CMPRIOR and CMONGO in the Concomitant Medications (CM) dataset.
| | 2 | Figures 2 and 3 | Reference time point | - Two reference time points are defined for the subject: the screening visit and the date of last contact.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-436 |
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The reference time points (represented by B and C) are part of the overall context of the study. - Observations about concomitant medications used by the subject with the timing of use are collected in relation to the reference time points:
- For A, the start and end dates for the concomitant medication are known and are collected.
- Collection fields CMSTDAT and CMENDAT are used to collect the start and end dates for the concomitant medication.
- For D, the start date for the concomitant medication is unknown and cannot be collected.
- Collection field CMPRIOR is used to collect that the known start of the concomitant medication relative to Screening is prior to the subject's screening visit.
- Collection field CMENDAT is used to collect the known end date.
- For E, the discontinuation date for the concomitant medication is unknown and cannot be collected.
- Collection field CMSTDAT is used to collect the known start date.
- Collection field CMONGO is used to collect that the use of the concomitant medication is ongoing relative the subject's date of last contact.
- The following variables are used to represent collected data in subsequent tabulation datasets:
- CMSTTPT and CMENTPT represent the date or a short description of the subject's screening visit and last contact respectively in the CM dataset.
- CMSTRTPT and CMENRTPT represent values from collection variables CMPRIOR and CMONGO in the CM dataset.
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