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Timeframes (referred to as study reference periods), 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 collected observations are defined:

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

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• 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 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 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 reference period or the date of a fixed point in time or milestone.

see Section 8.1.1,

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General CDASH Assumptions for Interventions Domains, and Section 8.2.1, General CDASH Assumptions for Events Domains

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For all SDTM submissions, there is a defined timeframe (the study reference period). According to SDTMIG, the start and end dates of the study reference period are submitted in the variables RFSTDTC and RFENDTC. The defined period may be protocol-specific or set by company policy, standard operating procedures, or other documented procedures. The study reference period might be defined as being from the date/time of informed consent through the date/time of subject's completion of the study, or it might be from the date/time of first dose to the date/time of last dose. Regardless of how the study reference period is defined, the dates (and optionally times) of the start and end of that period must be collected.

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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. 

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