Ccrp socra exam stuvia Study guides, Class notes & Summaries

When was the Nuremberg Code created? - ANSWER-1947 What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? - ANSWER-1979 What does the Belmont report do? - ANSWER-- Establish boundaries between practice and research - created ethical principles: Respect for persons, Beneficence, and Justice - ensure applications of informed consent, ri...

Contract Research Organization - ANSWER-A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER-False-they must sign both What is FDA form 3454 - ANSWER-Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical princip...

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER-5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER-3 Al IRB records need to be kept for ____ years follow completion of research - ANSWER-3 FDA will provide written determinati...

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - ANSWER-Respect for Persons, Beneficence, Justice The principle of justice in the Belmont report relates to - ANSWER-Distributions of burdens and benefits Respects for person in the Belmon...

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER -Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - ANSWER -Respect for Persons, Beneficence, Justice The principle of justice in the Belmont report relates to - ANSWER -Distributions of burdens and benefits Respects for person in the Bel...

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. Which of the follow...