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SOCRA Exam Questions With 100% Correct Answers 2023 What is an orphan drug program? - Correct Answer-FDA program that provides development of drugs for rare diseases Nuremburg Code - Correct Answer-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - Correct Answer-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - Correct Answer-any unfavorable or unintended event associated with a research study Assent - Correct Answer-a child's affirmative agreement to participate in a clinical investigation Assurance - Correct A
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What is an orphan drug program? - Correct Answer-FDA program that provides development of drugs for rare diseases Nuremburg Code - Correct Answer-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - Correct Answer-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - Correct Answer-any unfavorable or unintended event associated with a research study Assent - Correct Answer-a child's affirmative agreement to participate in a clinical investigation Assurance - Correct Answer-renewable permit granted by a federal department to an institution to conduce research Belmont Report - Correct Answer-Ethical principle and guidelines for protection of human subjects of research. Cornerstone document of ethical principles. Federal regulation of subject protection based on respect for persons, beneficence and justice---- what is beneficence according to the belmont report? - Correct Answer-ratio/risk, doing no harm, maximizing benefits while minimizing risks What is respect for persons according to the belmont report? - Correct Answer-informed consent, autonomy, protect the vulnerable, protect confidentiality what is justice according to the belmont report? - Correct Answer-subject selection is fair, benefits and burdens should be justly distributed Clinical research - Correct Answer-study of drug, biologic or device in human subjects with the intent to DISCOVER potential beneficial effects and/or determine its safety and efficacy. common rule - Correct Answer-also known as 45 CFR 46 Subpart A --ABC's of this are Assurance, Board review (IRB), Consent
declaration of helsinki - Correct Answer-statement of ethical principles first published by world medical association in 1964 to define rules for therapeutic and non-therapeutic research food drug and cosmetic act - Correct Answer-states only drugs, biologics and devices proven safe and effective can be marketed-- good clinical practice (GCP) - Correct Answer-international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate and that the subject's rights and confidentiality are protected human subject - Correct Answer-a patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction International Conference of Harmonization (ICH) - Correct Answer-an organazation composed of expert working groups from industry and regulatory bodies in the European Union, Japan and the US. This publishes guidelines for worldwide GCP with the goal of standardization for clinical trials of drugs. National Research Act - Correct Answer-this Act created the National Commission for Protection of Human Subjects of Biomedical and Behavioral research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent Office of Human Research Protection (OHRP) - Correct Answer-federal government office that issues assurances and overseas complicance placebo - Correct Answer-an inert substance used as a comparison to an active ingredient in clinical trials research - Correct Answer-systematic investigation designed to develop or contribute to generalizable knowledge serious adverse event (SAE) - Correct Answer-any event that results in death, a life threteaning situation, hospitalization or prolonged hospitalization, disability, incapacity or a congenital anomaly/birth defect source data - Correct Answer-all information contained in original records and certified copies of results, observations, or other facets required for reconstruction and evaluation of the study that is contained in source documents minimal risk according to 21 CFR 56 - Correct Answer-the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than
those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests Clinical Equipoise - Correct Answer-refers to the state in which there is an honest, professional disagreement among experts about whether the proposed study interventions should be the preferred treatment or practice. Genuine uncertainty about which intervention is better, experimental or control intervention. therapeutic misconception - Correct Answer-the belief that experimental treatment is for the benefit (treatment) of the individual patient therapeutic - Correct Answer-treatment under investigation is BELIEVED to be likely to benefit subjects in some way non-therapeutic - Correct Answer-GAIN knowledge which may contribute towards future development of new forms of treatment ( MAY or MAY NOT benefit, usually Phase I) Phase I - Correct Answer-investigates pharmacokinetics of drug- typically smaller # of subject less than 100. Tests safety, toxicity, pharmacokinetics, identify side effects, dose escalation, single dose, placebo Phase II - Correct Answer-most rigidly controlled @ 200 subjects, see if effective and further evaluate safety, maximum effective dose (efficacy) Phase III - Correct Answer-Pivotal Trial- overall evaluation of drug, adequate basis for physician labeling, provides majority of data for marketing, randomized control, 1000's subjects Phase IV - Correct Answer-Post Market Studies, may involve additional age or ethicnic groups, 1000's subjects, don't have control designs 4 topics Efficacy Safety Quality Multidisciplinary - Correct Answer-ICH guidelines are divided into how many categories and what are the categories?