Monitoring in clinical trials

Monitoring in Clinical Trials

Monitoring in clinical trials (pronunciation: mon-i-tor-ing in klin-i-kal trahy-uhls) is a critical aspect of the clinical trial process. It involves the oversight and administrative efforts to ensure that the clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

Etymology

The term 'monitoring' is derived from the Latin word 'monere', which means 'to warn' or 'to advise'. The term 'clinical trial' is a combination of the words 'clinical', which pertains to the observation and treatment of actual patients, and 'trial', which refers to a test or experiment.

Definition

Monitoring in clinical trials refers to the process of ensuring that the rights, safety, and well-being of trial subjects are protected, and that the trial data are accurate, complete, and verifiable from source documents. It involves regular on-site visits or remote assessments by the sponsor, or a clinical research organization (CRO) appointed by the sponsor.

Related Terms

• Clinical Trial Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.
• Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
• Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.
• Clinical Research Organization (CRO): A company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.

See Also

• Clinical Trial
• Clinical Research
• Data Monitoring Committee
• Ethics Committee
• Informed Consent

External links

• Medical encyclopedia article on Monitoring in clinical trials
• Wikipedia's article - Monitoring in clinical trials

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