Ended: Nov. 5, 2019
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.
Sponsor: MGH Division of Clinical Research
Sessions
REDCap Post Test |
Nov. 5, 2019
11/5/19 12AM-1AM |
12 AM – 1 AM | |
REDCap Post Test |
Nov. 5, 2019
11/5/19 3PM-4:30PM |
3 PM – 4:30 PM |
Simches 3.120, Floor 3, Simches Research Center
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Other Offerings
Past Offerings | ||
---|---|---|
IND and IDE Responsibilities for Sponsor-Investigators and Study Staff | REDCap Post Test |
June 16, 2021
06/16/21 |
IND and IDE Responsibilities for Sponsor-Investigators and Study Staff | REDCap Post Test |
April 9, 2021
04/9/21 |
IND and IDE Responsibilities for Sponsor-Investigators and Study Staff | REDCap Post Test |
Feb. 17, 2021
02/17/21 |
IND and IDE Responsibilities for Sponsor-Investigators and Study Staff | REDCap Post Test |
Jan. 14, 2020
01/14/20 |