MGH Division of Clinical Research

IRB Roundtable: Amendments and Reporting to the IRB

Ended: Nov. 9, 2017

Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI).

Speaker:Jo O'Driscoll-Davis, Assistant Director for Continuing Review and Administrative Chair

Per Federal Regulations, and Partners HRC policies, investigators and research staff are required to submit any new proposed changes to currently approved studies prior to implementing the change. Investigators must also report unanticipated problems (including adverse events) to the IRB. Maria Sundquist and Jo O'Driscoll-Davis, of the Partners Human Research Office will review requirements and procedures for submitting amendments and unanticipated problems. The presentation will include how to avoid common errors when completing the amendment applications, what study documents need updating based on the proposed changes, and what kinds of changes to an approved protocol prompts review at full board. The presentation will also include defining Unanticipated Problems (UAPs) and Adverse Events (AEs) and when to report them to the IRB.

This session is limited to 25 participants to facilitate interaction.

Registration is required. Please contact Tiereny Morrison-Rohlfs at tmorrison-rohlfs@partners.org with any questions.

Programs:
Beginner Clinical Research Coordinator Clinical Research Investigator Experienced Clinical Research Coordinator

Categories:
Clinical Research Ethical Oversight IRB

Sponsor:
MGH Division of Clinical Research

Sessions

Nov. 9, 2017 11/9/17
12PM-1PM 		12 PM – 1 PM
Garrod/Mendel, Floor 2, Simches Research Center

Other Offerings

Past Offerings
IRB Roundtable: Amendments and Reporting to the IRB Nov. 20, 2019 11/20/19
IRB Roundtable: Amendments and Reporting to the IRB Dec. 6, 2018 12/6/18
IRB Roundtable: Amendments and Reporting to the IRB Nov. 3, 2016 11/3/16

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Date Reviewed: Jan. 21, 2020, 12:53 p.m.
Thiti W:
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Date Attended: Nov. 20, 2019, 12:52 p.m.
Date Reviewed: Jan. 21, 2020, 12:36 p.m.
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Date Attended: Nov. 20, 2019, 12:07 p.m.
Date Reviewed: Jan. 21, 2020, 12:17 p.m.
Anonymous:
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Grace H:
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Date Attended: Dec. 6, 2018, 12:01 p.m.
Date Reviewed: Dec. 6, 2018, 1:37 p.m.