Socra ccrp stuvia - Study guides, Class notes & Summaries

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 principles of the Belmont Report? - ANSWER- Respect for persons. Beneficence. Justice. Phase III - ANSWER- Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1...

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...

Nuremberg Code (1947) - ANSWER A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - ANSWER 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end tria...

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...

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...

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...