ACRP "CCRC" Exam Glossary Questions With Verified Answers 2024

ACRP "CCRC" Exam Glossary Questions With Verified Answers 2024 Adverse Drug Reaction (ADR) - answerIn 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. Adverse Event (AE) - answerAny 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) - answerAny law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Approval (in relation to Institutional Review Boards) - answerThe 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 - answerA 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). Audit Certificate - answerA declaration of confirmation by the auditor that an audit has taken place. Audit Report - answerA written evaluation by the sponsor's auditor of the results of the audit. Audit Trail - answerDocumentation that allows reconstruction of the course of events. Blinding/Masking - answerA procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single Blinding - answerrefers to the subject(s) being unaware Double Blinding - answerrefers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). Case Report Form (CRF) - answerA printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. Clinical Trial/Study - answerAny investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. Clinical Trial/Study Report - answerA written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report Comparator (Product) - answerAn investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Compliance (in relation to trials) - answerAdherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality - answerPrevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract - answerA written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial ma