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Event Details

(Virtual: Zoom) IND and IDE Responsibilities for Sponsor-Investigators & Study Staff

**This session will be held virtually on Zoom. The link will be sent to those who register with a BWH/MGH/Partners-affiliated email address ~1 day prior to the session**

CLICK HERE TO REGISTER

This course is highly recommended for investigators and study staff conducting clinical trials under an IND or IDE, or for those who plan to in the upcoming year.

Principal Investigators (PIs) 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 MGB institutional policies.

In the case of a sponsor-investigator held IND or IDE, the PI must comply with two sets of regulations - sponsor regulations and investigator regulations - resulting in an increased regulatory burden on study teams and the increased potential for noncompliance.

In this program, the MGB Human Research Affairs Compliance & Education Office will outline the responsibilities of a sponsor-investigator and study-staff-delegated tasks on behalf of an investigator. Additionally, there will be a discussion on how to best meet these responsibilities, maintain compliance, and be audit-ready.

Speaker: Pamela Richtmyer - Director, MGB Human Research Affairs Compliance & Education

CLICK HERE TO REGISTER


The IND and IDE Responsibilities for Sponsor-Investigators & Study Staff training will be offered every other month through the MGB Human Research Affairs Compliance & Education Office. Future dates can be found here.


Event Type:

Class

Contact Information:

BWH Research Education
BWHResearchEd@partners.org
(617) 525-8849

Hosted By:


Brigham Research Education

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Date:

Monday, December 13, 2021

Time:

10:00AM - 11:30AM

Location:


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