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The figures below show collection of relative timing in relation to a study reference period and a fixed time point. Relative timing in relation to a milestone is collected in the same way as for a fixed timepoint. Representation of collected reference dates and relative timing in tabulation datasets is noted below and further described in Section x.x, Assumptions for Observation Classes and Section x.x Add tabulation section link.
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| Figure.Standards for Collection Reference Dates and Relative Timing |
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| Figure.Standards for Collection Reference Dates and Relative Timing |
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Description of Figures | Num | Figure | Reference | Description |
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| 1 | Figure 1 | Study Reference Period | - The study reference period is defined as the timeframe between a subject's first and last exposure to a tobacco product. This study reference period is part of the overall context of the study represented by B and C.
- 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.
- 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.
- 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 RFENDDTC represent the dates of the subject's first and last exposure dates respectively in the Demography (DM) dataset.
- CMSTRF and CMENRF represent values from collection variables CMPRIOR and CMONGO.
| | 2 | Figure 2 | Fixed Point in Time | - The fixed point in time is defined as a subject's Screening visit which is part of the overall context of the study (not shown).
- A, the start and end dates for the concomitant medication are known and are collected.
- D, the start date for the concomitant medication is unknown and cannot be collected.
- CMPRIOR is used to collect that the known start of the concomitant medication relative to exposure is prior to the subject's first exposure.
| | 3 | Figure 3 | Fixed Point in Time |
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