MGH Research Institute

Ended: June 16, 2021

Speaker: Pamela Richtmyer, Director, Mass General Brigham Human Research Quality Improvement Program

Principal Investigators (PI) who hold an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) agree to oversee the conduct of a clinical trial and remain in compliance with FDA regulations and Mass General Brigham policies. Investigators who hold an IND or IDE are considered Sponsor-Investigators and must comply with regulations for both an investigator and a sponsor. This results in an an increased regulatory burden on investigators and study teams.In this program the Mass General Brigham Human Subjects Quality Improvement Program will outline the responsibilities of a sponsor-investigator.

This course is highly recommended for investigators and study staff conducting or planning to conduct clinical trials under an investigator held IND or IDE.

Other Offerings, Save the Date- Registration to Come: Friday. April 9th 9:00-10:30am, Wednesday, June 16th 1:00-2:30pm, Friday, August 6th 9:00-10:30am, Wednesday, October 6th 1:00-2:30pm, Monday, December 13th 10:00-11:30am

Please contact Tiereny Morrison-Rohlfs at tmorrison-rohlfs@partners.org with questions.

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Sponsor: MGH Division of Clinical Research