POSSIBLEA QUALITY UPDATED EXAMS

What are the three fundamental ethical principles outlined in the Belmont Report (1979) for the protection of human subjects in research? Beneficence, Justice, Respect for Persons What is the purpose of the Belmont Report (1979)? To establish ethical principles and guidelines for the protection of human subjects in research. What defines an autonomous person? A person capable of deliberation about personal goals and of acting under the direction of such deliberation What does the pri...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Answer- Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: -Answer- Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to -Answer- maintain an audit trail, data trail, and ...

Phase I -Correct Answer The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? -Correct Answer Principal investigator Define GCP -Correct Answer An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 -Correct Answer Nazi Medical Experiments Which...

Treatment Emergent -Correct Answer An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. treatment effect -Correct Answer An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments. Surrogate Variable -Correct Answer A variable that provides an indirect measurement of effect in situations where direct measurement o...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Correct Answer Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for -Correct Answer Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to -Correct Answer maintain an audit tra...

What do these cause? Nephrotoxins Ischemia Pyelonephritis Hypo perfusion Hypotension Severe circulatory shock Heart Failure Mechanical obstructions Pre renal AKI Calculi, blood clots and tumors are mechanical obstructions that block urine flow beyond the kidneys cause what? Acute renal failure Drugs, chemicals and toxins that cause tubule necrosis and obstruction of blood flow is termed as? Nephrotoxins What are these clinical manifestations for? Polyurea Lethargy Oliguria Urem...

what are the clinical manifestation for alterations in arousal? -Correct Answer level of conscious changes which is the most critical evidence, pattern of breathing evaluates level of brain dysfunction, pupillary changes indicate level of brain stem dysfunction, oculomotor responses and motor response which help evaluate level of dysfunction and damaged side Brain Death is what? -Correct Answer total brain death, body can no longer maintain internal homeostasis, unresponsive coma, no spontane...

A pathology report identifies abnormal changes in the size, shape, and organization of mature cells. How would the nurse best classify these changes? -Correct Answer Dysplasia Which cellular change occurs in the liver of someone who has had a lobe of the liver removed? -Correct Answer Regeneration What does the nurse understand to be the most common cause of cellular injury? -Correct Answer Hypoxia During childhood, the thymus decreases in size. This is referred to as what type of atrop...

Which of the following is the most common cause of cellular injury? A. Hypoxia B. Chemical injury from drugs C. Free radical-induced injury D. Chemical injury from pollutants -Correct Answer A. Hypoxia Which type of necrosis best describes death of a cell from hypoxia, generally as a result of ischemia in the lower extremities? A. Fat B. Coagulative C. Liquefactive D. Gangrenous -Correct Answer D. Gangrenous Which statement is TRUE with regard to cellular change due to aging? ...

UTI or Acute Cystitis -Correct Answer - cloudy urine - caused by E. coli Pancreatitis -Correct Answer is caused by: - gallstones (bile duct disorder) - alcohol Rickets -Correct Answer - a term used for osteomalacia in CHILDREN - usually due to inadequate or lack of Vitamin D Appendicitis -Correct Answer - pain in the lower right quadrant (LRQ) Peptic Ulcer (Gastric) -Correct Answer - occult blood in stool - coffee-ground vomitus (coffee grains in the vomit) Sprain -Correct An...