T

In IWRS, an item tag is a useful marker or a note that can be added to an item for users' convenience; has no system logic.

Medical care given to a subject to mitigate or cure an illness, injury, or reduced health status. In a clinical trial, treatment may include prescribed drugs, biologics, devices, physical or psychotherapies, and such other procedures.

An established plan of medical care (prescribed drugs, procedures, and others) to be given to a subject to mitigate or cure an illness, injury, or reduced health status.

A compilation of documents proving that the study is held following regulatory requirements. The TMF is a crucial part of ensuring the trial is successfully managed by all the involved parties.

A document that summarizes the activities, observations, and findings of a monitoring visit conducted by a clinical research associate (CRA) or a monitor at a clinical trial site. The purpose of a trip report is to provide a detailed account of the visit, including the review of study data, source documents, regulatory compliance, and overall study conduct.