Clinical monitoring
Clinical Monitoring
Clinical monitoring (pronunciation: /ˈklɪnɪkəl ˈmɒnɪtərɪŋ/) is a critical aspect of clinical trials that ensures the safety and rights of trial participants are protected, and that the data generated is reliable and accurate.
Etymology
The term 'clinical' originates from the Greek word 'klinikos', which means 'bed'. In this context, it refers to the observation and treatment of actual patients. 'Monitoring' comes from the Latin word 'monere', which means 'to warn'. Thus, clinical monitoring is about overseeing and ensuring the proper conduct of clinical trials.
Definition
Clinical monitoring involves the oversight of a clinical trial, including the design, conduct, and analysis of a trial. It includes activities such as data verification, ensuring compliance with the protocol, and ensuring that Good Clinical Practice (GCP) guidelines are followed.
Related Terms
- Clinical Trial: A research study that tests how well new medical approaches work in people.
- Protocol: A detailed plan that sets out the objectives, design, and methods of a clinical trial.
- Data Verification: The process of checking that data collected during a clinical trial is accurate and consistent.
- 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.
Importance
Clinical monitoring is crucial in ensuring the safety of trial participants and the integrity of data collected during a clinical trial. It helps to identify and address any issues or discrepancies that may arise during the trial, ensuring that the results are reliable and can be used to support regulatory submissions.
See Also
- Clinical Trial Protocol
- Data Management in Clinical Trials
- Ethics in Clinical Trials
- Clinical Trial Design
External links
- Medical encyclopedia article on Clinical monitoring
- Wikipedia's article - Clinical monitoring
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