SOCRA Exam Questions With 100% Correct Answers

SOCRA Exam Questions With 100% Correct Answers Respect for persons, justice, beneficence - answerList the three ethical principles of the Belmont report Experiment that involves a test article and one or more human subjects - does not include experiments which are nonclinical lab studies - answerDefine clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control - answerHuman subject is: Life threatening circumstances deem use of test article necessary, inability to communicate or get legally affective consent, time not sufficient, no alternative method to saving life - answerConsent is Feasible unless all of following are true: Investigator - answerWhen consent is not obtained and and investigational device is used, who must report the characteristics of the device to the subjects physician within 5 working days? Investigator contacts other family and notifies IRB at continuing review - answerIf consent not feasible and no LAR who should be contacted and by whom for participation in emergency research? IRB - answerWho's responsibility is it to ensure that procedures are in place, to inform subjects or family members of investigational details as soon as possible in emergency research? 3 years after completion of clinical investigation - answerHow long is the IRB required to retain records from a clinical investigation? Must be performed under a separate IND or IDE that clearly includes subjects who are unable to consent - answerHow must protocols with exceptions to informed consent proceed under IND or IDE applications? Investigator and sponsor - answerIf IRB can't approve research who do they notify? Sponsor - answerWho informs the fda of disapproved research? Involves research Risks/discomforts, Benefits Alternates to participation Confidentiality Compensation Contact info Injury Voluntary - answerBasic required elements of informed consent Some risks are unknown Termination by PI Additional costs Consequences of withdraw New info provided Approx number of subjects - answerAdditional elements of informed consent Within five working days - answerTimeframe after consent is waived to notify IRB and physicians Short form stating that consent has been presented orally IRB approved written summary of what is said to subject Copies of each signed are given to subject - answerShort form consent documents Short form written consent doc- subject, and witness Copy of summary- signed by witness and consent authorized - answerWho signs what in the short form consent process? True - answerTrue or false- drugs intended solely for tests in vitro or in lab research animals, or placebos are exempt from cfr 312.160 A person that assumes as an independent contractor with the sponsor one or more of the obligations of a sponsor for example design of a protocol, selection or monitoring of investigations, evaluation of reports, in preparation of materials to be submitted to the FDA - answerContract research organization (cro) Sponsor must: