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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