Under FDA regulations, an academic sponsor or sponsor-investigator has the same obligations as a multi-national device manufacturer that sponsors or holds an IDE. Investigators who initiate and submit an IDE application to the FDA assume the responsibilities of both the investigator and the sponsor. Sponsor-Investigator Responsibilities for IDE.Study team can use this Word version to make modifications that reflect specifics of their study. This form is for researchers to use to conduct a self-assessment of their IRB approved study to ensure that the regulatory and institutional requirements for protocol adherence/reporting are met. This form is for researchers to assist in the required documentation of monitoring which is a FDA requirement for non-significant risk device studies. The purpose of this self-assessment is to help researchers assess whether they’re meeting their regulatory obligations and institutional guidance for Non-Significant Risk Devices. This form is for researchers to use to conduct a self-assessment of their IRB approved study to ensure that the regulatory and institutional requirements for obtaining and documenting informed consent are met. Informed Consent Process (fillable PDF).Informed Consent Documentation (Word version).This form is for researchers to use to conduct a self-assessment of their IRB approved study to ensure that the regulatory and institutional requirements for documenting eligibility criteria are met. This checklist is intended as a resource for investigators to ensure they are meeting the additional DoD requirements and should be reviewed at the time of initial U-M IRB approval and annually until the research has concluded. Investigators who conduct research sponsored by the Department of Defense (DoD), including collaboration with DoD, or involving DoD facilities or personnel (military or civilian), must follow additional regulatory requirements. This document is designed to assist investigators in assessing the adequacy of data protection mechanisms in place for a given study. Use this checklist to perform a self-assessment regarding the completion and quality of registration and/or results information entered into prior to releasing the record for review and publication. Registration and Results QA/QI Checklist.
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