Clinical trials unit

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Clinical Trials Unit

The Clinical Trials Unit (klin-i-kal trahy-uhls yoo-nit, from Latin clinicus meaning "bedside" and trial meaning "a test of the quality, value, or usefulness of something") is a specialized department within a hospital, university, or other medical research facility that designs and manages clinical trials.

Definition

A Clinical Trials Unit (CTU) is a specialized entity that provides the infrastructure for the design, promotion, management, and reporting of clinical research. The CTU is often involved in studies of new medications, treatments, or medical devices, and it plays a crucial role in ensuring that these studies are conducted ethically and effectively.

Function

The primary function of a CTU is to facilitate the conduct of clinical trials. This includes the design of the trial, the recruitment of patients, the collection and analysis of data, and the reporting of results. The CTU works closely with investigators, sponsors, and regulatory authorities to ensure that the trial is conducted in accordance with ethical guidelines and regulatory requirements.

Related Terms

  • Clinical trial protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.
  • Randomized controlled trial: A type of scientific experiment that aims to reduce bias when testing a new treatment.
  • Investigator (clinical research): A person responsible for the conduct of the clinical trial at a trial site.
  • Sponsor (clinical research): An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

Etymology

The term "Clinical Trials Unit" is derived from the Latin clinicus, meaning "bedside", and the English trial, meaning "a test of the quality, value, or usefulness of something". The term "unit" is used to denote a department or team within a larger organization.

External links

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