Run a participant activity

Example

At Week 4, the protocol requires vital signs, a participant questionnaire, a blood specimen, an image acquisition, and treatment dispensation.

Shared intent

Week4Encounter
├── VitalSignsActivityPlacement
├── QuestionnaireActivityPlacement
├── BloodCollectionActivityPlacement
├── ImagingActivityPlacement
└── DispensationActivityPlacement

Participant realization

The ParticipantSchedule derives applicable ParticipantScheduleItem objects from the participant’s Protocol Assignment, treatment/cohort state, prior occurrences, and timing anchors.

Each item identifies:

• the exact Activity Placement;
• expected date or trigger;
• permitted window;
• applicability and requiredness;
• responsible performer/domain;
• recalculation and supersession history.

Conduct

The encounter produces one or more ActivityOccurrence objects:

Activity	Occurrence output
Vital signs	Clinical observations and revisions
Questionnaire	eCOA responses and completion
Blood collection	Specimen and chain-of-custody events
Imaging	Image set, quality assessment, and read
Dispensation	Kit movement and dispensation decision

Rules to verify

• The encounter grouping is not itself proof that each activity occurred.
• Partial, missed, cancelled, and not-applicable activities have different meanings.
• Every output identifies its governing definition and occurrence.
• Source observations remain authoritative within their acquisition domain.
• Reconciliation identifies missing or conflicting outputs without overwriting them.
• A performed activity may propose a payable or Trial Artifact; those domains decide acceptance.

Product review questions

• Is one encounter occurrence enough, or does every activity always need its own occurrence?
• Which timing anchor wins when the encounter date changes after data collection?
• Can activities be performed independently outside their encounter grouping?
• How should a late activity affect protocol deviation assessment?