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Visit structure

In a clinical trial, a visit refers to a specific occasion when a study subject attends a designated location, such as a site, to have an encounter with the research team, allowing the latter for data collection, monitoring, safety assessment, protocol adherence, and endpoint evaluation. Visits play a crucial role in generating reliable and meaningful study results that contribute to the scientific understanding of the intervention that is investigated.

Before the visits can take place throughout the clinical trial, they need to be structured to have the planned schedule that participants need to undertake during the study period. The visit structure is carefully designed and standardized to ensure consistent and systematic evaluation of the trial's objectives. When building the visit structure, the following points are considered:

  • The visit structure is primarily defined during the protocol development phase. The protocol outlines the objectives, design, methodology, and data collection procedures, specifying the number and timing of visits required to address the research questions and collect the necessary data.

  • The visit structure is aligned with the study objectives and endpoints, which are the specific outcomes or measurements used to evaluate the intervention's effectiveness. The timing and frequency of visits are determined based on when the endpoints are expected to occur or change significantly.

  • The visit structure incorporates safety monitoring assessments to ensure participants' well-being and detect any adverse events. These assessments may include physical examinations, laboratory tests, vital sign measurements, and assessments of symptoms. The frequency of visits for safety monitoring depends on the potential risks associated with the intervention and the trial's duration.

  • The visit structure must comply with regulatory requirements and ethical guidelines. Regulatory authorities often provide guidelines on the frequency of visits and the type of data to be collected. Ethical considerations may require appropriate intervals for informed consent procedures and participant education at specific visits.

  • The visit structure needs to be practical and feasible for participants and the study site. Factors like participant burden, geographical location, and available resources are considered to minimize the impact on subjects and ensure successful study implementation.

  • The visit structure is flexible and adaptive to suit the protocol amendments in the course of the trial needed to address emerging needs or new safety information. All the changes are carefully documented and communicated to all relevant stakeholders as well as reflected in the Study Designer application.

  • The study design, such as a randomized controlled trial (RCT) or observational study, influences the visit structure. In an RCT, participants are often required to attend visits at specific intervals, including baseline, treatment initiation, and follow-up visits. The design also determines whether there are different study arms or treatment groups, which may require additional visits or assessments.

In Study Designer, the visit structuring is achieved through the following entities:

  • Visit folders: are added to the system to compile the related visits into manageable groups, for instance, additional assessments (unscheduled visits) can be added to folders.

  • Visits: are added to the system to outline a schedule of encounters with different activities and associated CRFs for your trial.

  • Cycle groups: are added to the system to collect the cycles—planned sequences of treatments and recovery periods that participants undergo during the study.

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.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.