ACRP CCRA/CCRC Certification Exam Prep Already Passed

ACRP CCRA/CCRC Certification Exam Prep Already Passed Adverse Event (AE)/Adverse Experience Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See Section III.c) Serious Adverse Event (Experience) or Reaction Is any untoward medical occurrence that at any dose: Results in death, Is life-threatening "life-threatening" in the definition of "serious" In the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect. Marketed Medicinal Products A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. "Unexpected" Adverse Event/Reaction The nature or severity of which is not consistent with information in the relevant source document(s). Until source documents are amended, expedited reporting is required for additional occurrences of the reaction. "Expected" Adverse Event/Reaction For a medicinal product not yet approved for marketing in a country, a company's Investigator's Brochure will serve as the source document in that country. Reports which add significant information on specificity or severity of a known, already documented serious ADR constitute unexpected events. Applicable Regulatory Requirements Any laws and regulations addressing the conduct of clinical trials of investigational products. (ICH GCP E6 1.4) "Approval" (in relation to Institutional Review Boards) 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 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). Audit Certificate A declaration of confirmation by the auditor that an organization audit has taken place. Audit Trail Documentation that allows reconstruction of the course of events. Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10) Case Report Form (CRF) A 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 Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other PD effects of an IP(s), and/or to identify any AEs to an IP(s), and/or to study absorption, distribution, metabolism, and excretion of an IP(s) with the object of ascertaining its safety and/or efficacy. Clinical Trial/ Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and