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4/6/20

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

Answer: Investigator Monitoring Clinical Trials of Drugs by Industry Sp…




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Who has ultimate responsibility for an investigational product? CITI Certification Who has ultimate responsibility for an investigational product ? Investigator. Investigational product dispensing or administration information for the sponsor is recorded on the: Case report form. ... CITI training 134 Terms. Lilo_5790. Amgen Questions 94 Terms. mlaitenberger. All Practice Exam Final 808 Terms. 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 subject 20 has brief dizzy spells upon trying to stand. 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 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 appr...


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