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V

Glossary

variable

An individual piece of data collected within a domain. It represents a specific attribute or characteristic that can vary among subjects in a study. Each variable is defined by its format (such as categorical, continuous, and so on) and plays a crucial role in data analysis, allowing researchers to assess relationships and outcomes in the study.

For instance, within the "Demographics" domain, variables might include "Age," "Gender," and "Ethnicity."

vendor

A client’s partner company represented by an automated system that derives clinical data and sends it to, or receives it from the eClinical system.

verbatim term

In Pharmacovigilance, a common term used by the AE/SAE case reporter to describe the patient's condition, symptoms, and other details. In ICSR, the verbatim terms are coded (translated) into standardized preferred terms to meet the regulatory requirements.

visit

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.

visit window

A time span that defines the allowable range for a subject visit in case it is not possible to conduct that visit on the exact scheduled visit date.