A timeframe (referred to as a reference period), fixed points in time (referred to as reference time points), 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 fields when references for the timing of other observations are defined:
- Start and end dates, and times as applicable, for reference periods.
- Dates, and times as applicable, for reference time points and/or milestones used as references.
The date, and time as applicable, of an observation to be 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 reference time point 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 reference time point or milestone.
The following steps should be taken when designing CRFs to ensure observations of interest can be related to reference periods, reference time points, and/or milestones.
- First, define the study reference period, reference time point, or milestone in the context of the study.
- Collect the start and end date/times of the study reference period, the date/time of the reference time point, or date/time of the milestone using appropriate TIG Collection or CDASH Model fields.
- Collect relative timing as needed using fields --PRIOR and --ONGO (e.g., “prior”, “ongoing”) for when an observation started or continued, in relation to the study reference period, reference time point, or milestone.
The figures below show collection of relative timing in relation to a study reference period and reference time points. Relative timing in relation to a milestone is collected in the same way as for a reference time point. Representation of collected reference dates and relative timing in tabulation datasets is noted below and further described in Section x.x, Assumptions for Observation Classes and Section x.x Add tabulation section link.