MGH Division of Clinical Research

IRB Roundtable: Continuing Review and Amendments

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

Speakers: Jo O'Driscoll-Davis, Assistant Director for Continuing Review and Administrative Chair Michael Ducey, Senior Human Resource Specialist and the Administrative Chair for BWH Panel B

Learn how your Continuing Review and Amendments are handled by the IRB staff at intake and what is required at full board for review. Also, how and what the Administrative Chairs (voting members of the IRB) review and consider at Continuing Review. The Administrative Chairs will use the PHRC Guide to Review of Non-Exempt Human Subjects Research to identify and discuss ethical and scientific issues, including how recruitment, consenting and safety monitoring is handled and how some of these issues can be addressed in your submission. 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: Clinical Research Investigator Beginner Clinical Research Coordinator Experienced Clinical Research Coordinator

Categories: Clinical Research Ethical Oversight IRB

Sponsor: MGH Division of Clinical Research

Modules

IRB Roundtable: Continuing Review and Amendments

Past Offerings

IRB Roundtable: Continuing Review and Amendments Oct. 13, 2016
IRB Roundtable: Continuing Review and Amendments Oct. 12, 2017
IRB Roundtable: Continuing Review and Amendments Nov. 1, 2018
IRB Roundtable: Continuing Review and Amendments Sept. 26, 2019

Reviews

Anonymous: The slides were very text heavy and hard to read. The slides were also not provided before class, so following along became quite difficult. Delay in CR review and how to prevent lapses was not addressed (despite study team submitting the CR at the 90 days notification).
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Date Reviewed: Jan. 21, 2020, 4:55 p.m.
Anonymous: I definitely learned new things from this class, but I wish I had it sooner. Some of things presented, we had learned as a group previously only because we made mistakes. I recommend adding this as a monthly course for coordinators/research staff.
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Date Reviewed: Sept. 26, 2019, 1:18 p.m.
Nopporn T:
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Date Attended: Sept. 26, 2019, 11:57 a.m.
Date Reviewed: Sept. 26, 2019, 1:12 p.m.
Anonymous: Slides were not updated to talk specifically about Insight version 4.0. Course was useful to ask specific questions of the instructor about new Insight version, but the presentation of content was not very organized at all. Also didn't introduce basic concepts of amendments and continuing reviews first, so if there were people in the room who didn't already have experience with these, I'm guessing they were quite lost.
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Date Reviewed: Nov. 2, 2018, 11:39 a.m.
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Date Reviewed: Nov. 1, 2018, 4:53 p.m.
Siobhan G:
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Date Attended: Nov. 1, 2018, 12:05 p.m.
Date Reviewed: Nov. 1, 2018, 3:20 p.m.
Anonymous: This session was very specific to the idiosyncrasies of Insight 4.0 in relation to Continuing Review and Amendments. It could have been more applicable to everyone if the content had been more general.
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Date Reviewed: Nov. 1, 2018, 2:48 p.m.
Melody C:
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Date Attended: Nov. 1, 2018, 12:14 p.m.
Date Reviewed: Nov. 1, 2018, 2:29 p.m.
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Date Reviewed: Nov. 1, 2018, 1:45 p.m.