Citi training study guide - Study guides, Class notes & Summaries

Three principles of Belmont Report - Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - TRUE The Belmont Report Respect for Person - Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines an...

Three principles of Belmont Report - Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - TRUE The Belmont Report Respect for Person - Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines an...

What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Inherent controls An example of an individual financial COI is: - A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - There may be bias by the peer reviewer...

What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Inherent controls An example of an individual financial COI is: - A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - There may be bias by the peer reviewer...

An example of an institutional COI is: - An industry sponsor pays for the construction of a new research laboratory at the organization The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - There may be bias by the peer reviewer as to the area of research During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - Disclose their potentia...

CITI TRAINING STUDY GUIDE TEST QUESTIONS AND ANSWERS private information - Answer-information about behavior that occurs in a context in which an individual can reasonably assume that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which he or she can reasonably expect will not be made public (for example, a medical record)

CITI Training 2023 study guide

CITI GCP Training Study Guide Test. ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the...

CITI Training 2023 study guide.