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From course:

DRUG DISCOVERY DEVELOPMENT (DDD)

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Question:

Responsibilities of Sponsors and Investigators

Author: LEIGHTON DWIGHT OBILLOS


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Answer:

1 SELECTING QUALIFIED INVESTIGATORS 2 PROVIDING THEM WITH THE INFORMATION they need to conduct an investigation properly 3 ENSURING PROPER MONITORING of investigation, 4 ensuring that the investigation is conducted in ACCORDANCE WITH THE GENERAL INVESTIGATIONAL PLAN and protocols contained in the IND 5 ensuring that FDA and all participating INVESTIGATORS are promptly INFORMED OF SIGNIFICANT NEW ADVERSE EFFECTS OR RISKS


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