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10th Feb 2017, 10:13 AM
#1
As per GCP définitions :
1.53 Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
1.54 Sponsor-Investigator
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.
If the company is not responsible for initiating the trial (protocol writing, CT application , Regulatory approvals ...) and giving support to investigator (whatever support includes) it is considered as Sponsor Investigator Study.
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