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 Quality Improvement Program 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, Partners Human Research Quality Improvement Program