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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 fields when references for the timing of other observations are defined:
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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.
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- First, define the study reference period, fixed time point, or milestone in the context of the study.
- Collect the start and end date/times
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- of the study reference period
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- ,
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- the date/time of the fixed timepoint, 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
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- an observation started or ended, in relation to the
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- study reference period
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- ,
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- fixed
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- time point, or milestone.
The figures below show collection of relative timing in relation to a study reference period, a fixed time point, and a milestone. Each figure is described in the table below. Refer to Section x.x,
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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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