Clinical Chemistry > QUESTIONS & ANSWERS > CLINICAL RESEARCH COORDINATOR EXAM QUESTIONS WITH CORRECT ANSWERS (All)

CLINICAL RESEARCH COORDINATOR EXAM QUESTIONS WITH CORRECT ANSWERS

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

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