Clinical Research Coordinator exam

Clinical Research Coordinator
exam/questions with 100% complete
solutions

CRC - answer-Clinical Research Coordinator
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CRA - answer-Clinical Research Associate
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PI - answer-Principal Investigator
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CFR - answer-Code of Federal Regulations
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FDA - answer-Food and Drug Administration
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GCP - answer-Good Clinical Practice
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ICH - answer-International Conference on Harmonization
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SOP - answer-Standard Operating Procedure
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CRF - answer-Case Report Form. Electronic document designed to records all of the
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protocol required information to be reported to the sponsor on each trial subject and
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shared with the IRB.
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1572 Form - answer-Statement of Investigator; signed by the investigator to inform the
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FDA where the study is being done, who the PI is and who is helping them conduct
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the study, location of study, and what labs, and which IRB is being used.
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IND Safety Report - answer-A proposal through which a sponsor obtains FDA approval
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Xof its plans to test a new drug in human trials.
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Letter of Indemnification - answer-Contractual document that guarantees certain
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provisions will be met between two parties.
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IRB - answer-Institutional Review Board, To ensure the rights and safety of the
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Xresearch patient; the patient's advocate.
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ICF - answer-informed consent form- voluntary confirmation of a subject's willingness
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Xto participate in a trial and documentation thereof
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