NIH IPPCR FINAL TEST WITH 60 PRACTICE

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NIH IPPCR FINAL TEST WITH 60 PRACTICE

QUESTIONS AND CORRECT VERIFIED ANSWERS/ NIH

PRINCIPLES AND PRACTICES OF CLINICAL RESEARCH

(IPPCR) FINAL EXAM (NEWEST!)

Most guidelines, codes and regulations for ethical research include a requirement for informed consent. The process of informed consent includes the following

elements:

A written consent form with a disclaimer Understanding written information The signature of the participant ***Disclosure of information, understanding, voluntary choice, and authorization Which of the following is/are reasons to perform audits as part of your organization's Quality Assurance Programs?To assure all patient protection measures are followed To ensure protocol adherence To find and correct errors To ensure study results are valid ***All of the above What is/are the reason(s) that NIH requires the inclusion of women and minorities in all clinical research?United States legal requirement applicable to all NIH-supported investigators Ethical principle of justice Responses to clinical interventions may differ between males and females and/or different racial and ethnic groups ***All of the above A and B only If you are conducting clinical research that is funded by the NIH, you are always required to follow the Common Rule True In the proposed ethical framework for clinical research, the final principle "respect for enrolled subjects" is understood to include: 1 / 2

pg. 2 Establishing a contract between the subject and the researcher ***Monitoring the subject's welfare and protecting confidentiality of information Keeping the financial costs of participation reasonable Informing the subject of new information only after the study is published The NIH Library of Medicine hosts the clinicaltrials.gov website, which is

mandated by:

***FDA

Journal policy for publication

IND registration

All of the above Excluded research is a type of research that is subject to the U.S. rules for the protection of research subjects.***True False What is the purpose of having a detailed protocol for each clinical trial?Provide clear instructions so that the study procedures can be carried out the same way with all participants Provide detailed instructions for training new staff if there is turnover Improve the likelihood of reproducibility of the trial results by providing detailed documentation of how the trial was conducted ***aAll of the above For an individual patient being treated for an off-label indication with an FDA- approved product, an IND is NOT required.***True False Granted similar access to healthcare services (including screening and vaccinations), differences in health outcomes (e.g., remission, relapse, post- surgical complications) associated with disease X between two populations may

reflect:

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