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The following steps should be taken to ensure observations of interest that occur over time can be related to the study reference period or to a fixed point in time/milestone in a meaningful way. 


Metadataspec
NumRelative Timing Implementation
1Study Reference Period

  1. 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

  1. , date of first

dose

  1. exposure) and end of the study reference period (e.g., date of last

contact, date of last dose

  1. 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

SDTMIG

  1. TIG Demographics (DM) tabulation dataset.

  2. Collected comparisons (D, E) use
CDASHIG variables
  1. 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
CDASH
  1. collection variables are used to populate the
SDTMIG variables
  1. TIG Tabulation Variables--STRF and --ENRF variables when the
SDTM-based
  1. tabulation datasets are created.
Note: These relative timing variables are only populated in the SDTM -based datasets when a date is not collected.
2Fixed Point in Time/Milestone
  1. 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
SDTMIG variables
  1. TIG Tabulation Variables --STTPT or --ENTPT when the
SDTM-based
  1. tabulation datasets are created. 
  2. Collected comparisons (D or E) use
CDASHIG variables
  1. TIG Collection Variables (e.g., “prior”, “ongoing”)
 for
  1. for when something started or ended, in relation to the fixed point in time or milestone (B or C). These
CDASH
  1. collection variables are used to populate the
SDTMIG variables
  1. TIG Tabulation Variables--STRTPT or --ENRTPT when
the SDTM-based
  1. tabulation datasets are created
.
Note: These relative timing variables are only populated in the SDTM-based datasets when a date is not collected
  1. .