NAPSRx Certification Exam Study Guide Chapter 11

A term of A study of human subjects that is intended to ascertain an investigational products safety and efficacy by analyzing its clinical, pharmacological and/or other pharmacodynamic effects, ADME and/or adverse reactions? - Clinical Study According to who, trials are normally delayed at least a month because not enough subjects? - CISCRP (Center for Information and Study on Clinical Research Participation How much money does a company lose per day from a product delay? - $8 million What are the seven ethical stipulated requirements to ensure that, before a trial begins, there is proper consideration of ethical issues and that the trial subjects are protected according to the NIH? - 1) Social Value 2) Scientific validity 3) Fair Subject Selection 4) Informed consent 5) Favorable-risk benefit ration 6) Independent review (IRB/IEC) 7)Respect for human subjects This ethical requirement helps ensure that resources are not directed at non-meaningful clinical research and that human subjects are not exploited? - Social Value This ethical requirement states subjects should be selected based on scientific objectives and not on whether the subject is privileged or vulnerable, or because of convenience? - Fair Subject Selection This ethical requirement states that clinical trial should be conducted methodically with clear objectives and outcomes that are statistically verifiable? - Scientific validity This ethical requirement states subjects be informed about the aims, methods, risks, and benefits of the trial? - Informed Consent The ethical requirement that states a clinical trial should not be conducted if there is any doubt about this? - Favorable risk-benefit ratio This ethical requirement is a third party to oversee the welfare of the trial subjects and ensure the trial is conducted in accordance to the study being put forward, the third party has the right to stop the trial or require that procedures and methods be changed? - IRB/IEC This ethical requirement states subjects should be protected, their progress in the trial monitored closely, and provided with appropriate treatments? - Respect for Human Subjects