Citi certification - Study guides, Class notes & Summaries

According to the U.S. Public Health Service, the definition of the term "investigator": - Includes anyone involved in the conduct or reporting of research. An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug com...

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CITI Certification Questions & Answers. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT ANSWER Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - CORRECT ANSWER Respect for Persons, Beneficence, Justice The Belmont Report's principle of respect for persons incorporates at least two...

What must you file before conducting human clinical trials with an experimental drug? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND. - Form FDA 15...