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Qdossier Qsauri
"S"

sponsor investigator
Guideline or reference source
ICHE2F Development safety update report
ICHE6(r1) Guideline for good clinical practice
Definition
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
Used For
clinical investigator
Related Term
clinical research associate
clinical research coordinator
clinical study materials
collaborator
 

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