| Num | Figure | Reference | Description |
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| 1 | Figure 1 | Study Reference Period | - A represents the study reference period in the context of the study represented by B and C.
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.
| | 2 | Figure 2 |
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| | 3 | Figure 3 |
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