Free CCRC Detailed Role Questions and Answers

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A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation code list, documentation of IP destruction and final report to the IRB/IEC. Which of the following actions should the CRC perform?

Please select 3 correct answers

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A CRA calls a CRC to schedule the final monitoring visit. The sponsor requires that the PI be present. The only dates available for the CRA conflict with the PI's schedule. To prepare for the visit, the CRC should:

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The trough blood level for a once-daily drug should be drawn how long after the dose?

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A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medications. Which of the following questions should be asked by the CRC?

Please select 2 correct answers

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A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more inclusion/exclusion criteria. How long will it take the CRC to fulfill enrollment?

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Which of the following are responsibilities of an IDMC/DSMB

Please select 2 correct answers

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Which of the following scenarios are considered SAEs?

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