monitoring
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
- Related Term
- good clinical practice
- monitoring report
- monitoring visit
- protocol
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