U

A code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units.

An alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of FDA.

A document approved by the U.S. FDA and provided by pharmaceutical companies for healthcare professionals in the United States. The USPI is intended to accompany the marketed medicinal product and contains important safety and prescribing information.

The USPI is also known as the package insert in the United States and serves as a comprehensive reference guide for healthcare professionals when prescribing, dispensing, or administering medication to patients. It provides essential information about the drug's indications, dosages, contraindications, warnings, precautions, adverse reactions, drug interactions, and other critical details.

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.

In PV, an option to add a query question to ICSR without selecting any specific data elements to which it relates. This comment should be addressed by the EDC case reporter, but the system cannot automatically process the answer and implement it in the ICSR forms in PV.

See also: structured question

An organizational unit of the ADMIN app that brings together certain users with similar responsibilities, activities, and purposes to conveniently manage their access rights by providing unified permissions to view and interact with selected sites and depots.