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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 indicated 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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| Num | Figure | Reference | Description |
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| 1 | Figure 1 | Study Reference Period |
A represents the - 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
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in - is part of the overall context of the study represented by B and C.
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Define the “on-study” period (B-C). Once the overall on-study period has been defined (B-C), collect the dates/times of the start of the study reference period (e.g., date of informed consent, date of first dose) and end of the study reference period (e.g., date of last contact, date of last dose), as part of the clinical data with their respective domains (e.g., Disposition (DS), Exposure (EX)). These dates will map into the RFSTDTC (B; start of Study Reference Period) and RFENDTC (C; end of Study Reference Period) variables in the SDTMIG Demographics (DM) dataset. Collected comparisons (D, E) use CDASHIG variables (e.g., “prior”, “ongoing”) for when something started or ended, in relation to the on-study reference period (i.e., RFSTDTC-RFENDTC: B-C). These CDASH variables are used to populate the SDTMIG variables--STRF and --ENRF variables when the SDTM-based datasets are created.- Observations about concomitant medications used by the subject with the timing of use is collected in relation to the study reference period; for:
- 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.
- E, the subject has not discontinued the concomitant medication and therefore the end date for the concomitant medication cannot be collected.
- 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. | | 3 | Figure 3 | Fixed Point in Time |
2 | Figure 2 | 3 | Figure 3 |
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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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