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Visit folders

When designing a visit structure for your study, you have the option to add folders. The visit folders are usually created for storing unscheduled visits that need to be repeated according to the study protocol. Such unscheduled visits typically include assessment forms that need to be completed by healthcare professionals, such as study coordinators or investigators, who have been trained on the protocol. The assessment forms serve as a means to collect accurate and consistent data across different sites, ensuring that study results are reliable and can be analyzed effectively.

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

In this section:

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

A visit that occurs 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.

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

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.