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Visits

A visit refers to a scheduled appointment or meeting between a participant and the study team, usually at the trial site or a designated healthcare facility. Visits play a crucial role in clinical trials by facilitating subject monitoring, data collection, treatment administration, adverse event reporting, and ensuring adherence to the protocol. They also enable researchers to gather the necessary information to assess the safety, efficacy, and overall impact of the investigational treatment.

In Study Designer, the following visit types are available:

  • Scheduled Visits icon_visit_scheduled.png: these visits are preplanned and specified in the trial protocol. They are typically conducted at particular time points during the study period. The purpose of scheduled visits is to systematically assess subjects' progress, collect data, and perform necessary procedures. Scheduled visits often include baseline assessments, treatment initiation visits, follow-up visits at specific intervals, and study completion visits.

  • Unscheduled Visits icon_visit_unscheduled.png: these visits occur outside of the predefined schedule as the subject or the study staff initiates them in response to emerging symptoms, adverse events, or other issues that require immediate attention. Unscheduled visits are conducted to address participant concerns, assess unexpected reactions, or collect additional data not initially planned in the visit structure.

  • Common Visits icon_visit_common.png: these visits are a part of routine medical care for the specific condition being studied. Common visits may include routine medical assessments, laboratory tests, or diagnostic procedures that are relevant to the disease or condition under investigation. These visits serve as a baseline comparison and provide context to evaluate the impact of the intervention that is studied.

  • Cycle Visits icon_cycle_visit.png: these are the visits that are added as part of the cycle group. Cycle visits provide a structured framework for administering interventions, monitoring participants, and evaluating treatment effects. They help ensure consistency in treatment delivery and allow researchers to assess the long-term impact of the intervention on patients' health.

In this section, you can learn how to do the following:

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.