study monitoring
Glossaries
| Term | Definition |
|---|---|
| study monitoring |
The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.
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Synonyms:
Trial Monitoring |
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