IG updates identified when defining relationships

[BSnoeijerCD]

The following IG updates were identified when defining relationships:

• describe encounter-timing relationship
• describe activity-timeline relationship
• describe scheduledactivityInstance-timeline relationship
• describe ordering of eligibility criteria

[BSnoeijerCD]

I added the following text to the IG:

Regarding encounter timing relationship in section Study Timing: A timing may be referenced from an Encounter using the scheduleAt attribute allowing for a specific encounter timing and corresponding windowing to be defined and presented in a scheduled of activities. An Encounter timing might potentially overarch multiple scheduledInstances representing different blocks of activities within an encounter.

Regarding the activity timeline (also added scheduledTimeline to Activity UML): The Activity class can be linked to 1 or more procedures (see Section 4.12), 1 or more biomedical concepts (see Section 4.13), 1 or more groups of biomedical concepts, 1 or more surrogate biomedical concepts and/or a sub timeline. A sub timeline referred to from an activity would typically be a sequency of actions covered by the activity description (e.g. blood glucose profiles, sitting/standing vital signs sequences etc.).

Regarding the scheduledActivityInstance-timeline relationship => I think this was already addressed by the diagrams and following sentence in the Study Timing section: The timeline can also be attached to a ScheduledActivityInstance from another timeline using the timeline reference, thus allowing timepoints within a visit to be constructed, as shown in the following figure.

Regarding the ordering of eligibility criteria: Eligibility criteria inherit from the Syntax Template class, allowing for referencing any item stored in the USDM, such as assessments stored as BCs or an indication stored in the Indication class. They are defined within a study version which allows reuse within different study designs and different cohorts. The previous and next attributes define the presentation ordering within an eligibility criterion category or overall. The identifier attribute may be used to store the short name used for mapping to SDTM TI domains (see Creation of SDTM Trial Design Domains).