CITI Training Quiz Questions And Answers 2022/2023// CITI Training Questions And Answers 2022/2023// CITI training exam Questions And Answers 2022/2023// CITI Training, Modules 1-24 (Biomedical Research) 2022/2023// CITI TRAINING Questions and answers 202

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability - Answer- C. Economic vulnera...

What must you file before conducting human clinical trials with an experimental drug? - Answer- IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Answer- Maintain current IND application by amending IND with new Form FDA 1571 and pr...

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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons with...

Privacy, in the health information context, refers to: - Answer- The rules about who can access health information, and under what circumstances. In the U.S., privacy protections for health information come from: - Answer- Federal, state, local, and private certification organizations' requireme...

What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Answer- Inherent controls An example of an individual financial COI is: - Answer- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also t...

The Belmont principle of beneficence requires that: - Answer- Risks to subjects are reasonable in relation to anticipated benefits. Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - Answer- Respect ...

persons with diminished autonomy are entitled to protection - Answer- 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: Determining that the study has a maximizati...

Three principles of Belmont Report - Answer- Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Answer- MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Answer- TRU...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - Answer- Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A research...