What are Unscheduled Events?

Unscheduled events are participant visits, assessments, or clinical activities that occur outside the predefined study schedule outlined in the clinical trial protocol. These events are typically triggered by unexpected circumstances such as adverse events, worsening symptoms, missed visits, or additional safety evaluations during the study.

Unscheduled events may occur at any stage of a clinical trial when additional participant evaluation or intervention is required outside planned study visits. They help study teams respond to unexpected clinical situations while maintaining participant safety and continuity of study oversight.

These events are typically documented separately from protocol-defined visits and may involve additional assessments, safety reviews, laboratory tests, or follow-up procedures depending on the situation and study requirements.

During study setup, study teams can configure unscheduled visit options, related forms, and additional assessment workflows within Clinion’s unified eClinical platform based on protocol requirements. This allows research sites to document participant activities that may occur outside predefined study visits during trial conduct.

Participant data collected during unscheduled events can remain connected with related study records and visit histories across the platform. Centralized visibility also helps study teams maintain consistent documentation and traceability throughout the study.

A participant enrolled in a clinical trial may develop unexpected symptoms between scheduled follow-up visits and contact the research site for evaluation. In response, the site may arrange an additional unscheduled visit to perform safety assessments, collect laboratory samples, and review the participant’s condition.

The visit would then be documented separately from the participant’s planned study visit schedule according to the study requirements.

Study Visit
Schedule of Assessments
Visit Window
Adverse Event (AE)
Protocol Deviation
Follow-Up Visit

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