" /> Trial Compliance - CISMeF





Preferred Label : Trial Compliance;

NCIt related terms : compliance (in relation to trials);

NCIt definition : Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH);

Alternative definition : CDISC-GLOSS: Adherence to specifications in the study protocol and regulations by patients, investigators, and other study staff. NOTE: The investigator and sponsor have obligations to follow the protocol and GCP. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000.];

NCI Metathesaurus CUI : CL540676;

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