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"Investigator" Designation and "Engagement" Status in Decentralized Clinical Research - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

March 10, 2022 @ 2:00 pm 4:00 pm

Virtual Event

Research that is executed in part or in whole through remote modalities, such as telemedicine and health care providers who visit participant homes, is increasingly commonplace yet complicated. Decentralized research raises novel questions regarding whether and which institutions are engaged in research under the Common Rule and who is a subinvestigator according to United States Food and Drug Administration (FDA) regulations. Mark Barnes, MRCT Center Faculty Director, overviewed the concept of engagement in research subject to the Common Rule and proposed a model to redefine the concept of engagement. David Peloquin, MRCT Center Senior Advisor, overviewed the investigator and subinvestigator designations in research subject to FDA regulations.


Meeting Summary

Released on: March 10, 2022

Topic: Topic: “Investigator” Designation and “Engagement” Status in Remote Clinical Research