Question 1A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because: The organization can have policies that affect the research The members of the advisory board know each other The research result could be flawed from missing data It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s successQuestion 2The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies Researchers to annually self-disclose financial COIs to the FDA Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studiesQuestion 3An example of an individual financial COI is: A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study. A researcher’s spouse works at the same university as the researcher. A researcher’s 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher’s ongoing projects. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.Question 4The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Sponsor Researcher Organization IRB Member Applicants submitting marketing applications for drugs, biologics, or devicesQuestion 5The COI management plan aims to: Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed Eliminate all COIs in research when a COI is disclosed Reduce IRB review burden when a COI is disclosed Address disclosure of COIs in multi-center research when a COI is disclosed

Question 1An example of an individual financial COI is: A researcher’s spouse works at the same university as the researcher. A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study. A researcher’s 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher’s ongoing projects. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.Question 2What is the term for management controls that are built in to a research study (for example, independent data analysis)? Mandated controls Required controls Inherent controls Objective controlsQuestion 3The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Applicants submitting marketing applications for drugs, biologics, or devices Sponsor Researcher IRB Member OrganizationQuestion 4During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting Disclose their potential COI and not participate in any action Disclose their potential COI, but not answer any questions about the study Leave the meeting immediatelyQuestion 5An example of an institutional COI is: One of the organization’s deans is the vice-chair of the organization’s IRB The organization’s president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization The organization gives scholarships to some post-doctoral researchers An industry sponsor pays for the construction of a new research laboratory at the organization

Informed cosent should inform volunteers with all of the following except : Question 34AnswerThe right to be informed of relevant findingsRisks & benefits If the volunteer will receive the drug or placeboConcept of randomization & blindingType of the study

True or false . The Committee of Sponsoring Organizations (COSO) is an endorsed framework that companies commonly use to meetSOX 404 requirements. Formerly known as the Information Systems Audit and Control Association, this framework is an internationally recognized best practice.

he following are true about the CRIC, except ______.it’s a Canadian association of marketing research professionalsone of its goals is to increase public confidence in the industryCRIC’s principles are based on self-regulationCRIC has its own code of conduct

Certificates of Confidentiality (CoC) do not prevent investigators from releasing personal information without participant consent in which of the following cases:A. Matters such as child abuse or neglect.B. Reportable communicable diseases.C. Threatened violence or harm to self or others.D. All of the above.