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A timeframe (referred to as a study reference period), fixed points in time, and other milestones, may be defined in the context of a study as references to which the timing of other collected observations are related. The following will be collected using TIG Collection or CDASH Model Timing variables when references for the timing of other observations are defined:

  • Start and end dates, and times as applicable, for study reference periods.
  • Dates, and times as applicable, for fixed points in time and/or milestones used as references.

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.







The following steps should be taken when designing CRFs to ensure observations of interest can be related to study reference periods, fixed points in time, and/or milestones. 


NumReferenceSteps for Implementing Relative Timing Collection Variables
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 first exposure to study product) and end of the study reference period (e.g., date of last exposure to study product), 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.

  2. 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.
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 TIG Tabulation Variables --STTPT or --ENTPT when the tabulation datasets are created. 
  2. 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.



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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