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- Define the reference period and/or reference time point(s) in the context of the study.
- Collect the start and end date/times of the reference period and/or the date/time of the reference time point(s) using appropriate TIG collection or CDASH Model fields.
- Collect the actual timing of observations when it is possible to collect the date(s) for a related observation.
- Collect relative timing of observations when collection of actual dates is not possible using fields --PRIOR and --ONGO (e.g., “prior”, “ongoing”) for when an observation started or continued, in relation to the study reference period and/or reference time point(s).
The following figures below show collection of relative timing in relation to a reference period and reference time points; the table that follows describes the figures. Representation of collected reference dates and relative timing in subsequent tabulation datasets is noted below and further described in Section 2.7.4.1, Collection Assumptions and Section 2.8.7.6, Representing References and Relative Timing.
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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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The figures above are described in the table below. | Num | Figure(s) | Reference | Description |
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| 1 | Figure 1 | Reference Periodperiod | - The reference period is defined as the timeframe between a subject's first and last exposure to a tobacco product. This reference period (represented by B and C) 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:
- 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 RFENDDTC represent the dates of the subject's first and last exposure respectively 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 Pointtime point | - Two reference time points are defined for the subject, the subject's Screening : the screening visit and the date of last contact. The reference time points (represented by B and C) are 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 reference time points; for:
- 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 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 screening visit and last contact respectively in the Concomitant Medications ( CM ) dataset.
- CMSTRTPT and CMENRTPT represent values from collection variables CMPRIOR and CMONGO in the Concomitant Medications ( CM ) dataset.
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