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The date, and time as applicable, of an observation related to a reference will be collected whenever possible. Only in cases where it is not possible to collect the date of a related observation (e.g., the date is not available), will a relative timing for the observation in relation to a reference be collected. Relative timing will be collected using TIG Collection Variables:
- --PRIOR to indicate the timing of the observation was prior to the start date of a study reference period or the date of a fixed point in time or milestone; or
- --ONGO to indicate the timing of the observation was ongoing relative to the end date of a study reference period or the date of a fixed point in time or milestone.
see Section 8.1.1, General CDASH Assumptions for Interventions Domains, and Section 8.2.1, General CDASH Assumptions for Events Domains.
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The following steps should be taken when designing CRFs to ensure observations of interest that occur over time can be related to the study reference period or to a fixed point periods, fixed points in time/milestone in a meaningful way, and/or milestones.
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| Num | Relative Timing | Implementation |
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| 1 | Study Reference Period | 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 first exposure) and end of the study reference period (e.g., date of last exposure), 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 TIG Demographics (DM) tabulation dataset. - Collected comparisons (D, E) use TIG Collection 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 collection variables are used to populate the TIG Tabulation Variables--STRF and --ENRF variables when the tabulation datasets are created.
| | 2 | Fixed Point in Time/Milestone | - Define the fixed point in time or milestone (B or C). The fixed point in time or milestone can be a date or a description. This will map into the TIG Tabulation Variables --STTPT or --ENTPT when the tabulation datasets are created.
- Collected comparisons (D or E) use TIG Collection Variables (e.g., “prior”, “ongoing”) for when something started or ended, in relation to the fixed point in time or milestone (B or C). These collection variables are used to populate the TIG Tabulation Variables--STRTPT or --ENRTPT when tabulation datasets are created.
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see Section 8.1.1, General CDASH Assumptions for Interventions Domains, and Section 8.2.1, General CDASH Assumptions for Events Domains.
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