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11/8/19

[Answer] Who has ultimate responsibility for an investigational product?

Answer: Investigator




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Who has ultimate responsibility for an investigational product? Who has ultimate responsibility for an investigational product? Investigator an investigator conducting a study of a medical device under an IDE is required to complete and sign what During the course of administration of an investigational drug the following events occurred: On Day 7 subject 603 had an unexpected stroke that requires hospitalization; On Day 15 subject 415 complained of nausea vomiting and headache relieved by aspirin ; On Day 21 … means the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity including a company an academic organization or an individual . The intent of the sponsor's IND is to allow testing for marketing approval of the drug. During the course of administration of an investigational drug the following events occur: On Day 7 subject 603 has an unexpected stroke that requires hospitalization. On Day 15 subject 415 complains of nausea vomiting and headache relieved by aspirin . On … Who has ultimate responsibility for an investigational product? Investigator an investi...


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