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Research involving implantation of investigational pacemaker


Problem:

Which of the following activities is more than minimal risk and would not qualify for expedited review? Request to change the room in which a non-invasive research procedure will be conducted. Research involving the implantation of an investigational pacemaker. Research that requires no additional intervention or interaction with a subject other than obtaining consent to use, for research purposes, a portion of his/her information being obtained during clinical care. Quality of life questionnaire in which the subject reveals answers about how they interpret their health during receipt of clinical care.

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Other Subject: Research involving implantation of investigational pacemaker
Reference No:- TGS03393833

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