ACRP CCRC EXAM PREP| 135 questions| WITH COMPLETE SOLUTION
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Adverse Drug Reaction (ADR) Correct Answer: In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all ... noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Applicable Regulatory Requirement(s) Correct Answer: Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Approval (in relation to Institutional Review Boards) Correct Answer: The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. Audit Correct Answer: A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). [Show More]
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