MGH Division of Clinical Research

Clinical Research Skills: Essential Documents: What are they? What do they mean? How should they be filed?

Ended: July 17, 2018

Daniel Jones, Senior QA/QI Specialist, Human Research Quality Improvement Program

“If it wasn’t documented it didn’t happen!” In this session, we will review the list of essential documents and GCP requirements for documentation. For each document, we will describe the purpose – for example what is a delegation log for and what does an incomplete delegation log tell an auditor or monitor? We will also review a regulatory binder to point out what was done correctly, what could be improved and what was just wrong.

Programs:
Clinical Research Skills: Beginner Beginner Clinical Research Coordinator

Categories:
Clinical Research Skills Training

Sponsor:
MGH Division of Clinical Research

Sessions

July 17, 2018 07/17/18
12PM-1PM 		12 PM – 1 PM
Garrod/Mendel, Floor 2, Simches Research Center

Other Offerings

Past Offerings
Clinical Research Skills: Essential Documents: What are they? What do they mean? How should they be filed? July 18, 2018 07/18/18

Reviews

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Date Reviewed: July 18, 2018, 6:08 p.m.
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Date Reviewed: July 18, 2018, 4:24 p.m.
Anonymous: Auditing the study binder was a great, great activity.
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Date Reviewed: July 18, 2018, 2:40 p.m.
Courtney L: Great instructor. I really liked that we got to look through and evaluate an example of a regulatory binder. It really helps to get a hands-on view.
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Date Attended: July 18, 2018, 11:59 a.m.
Date Reviewed: July 18, 2018, 2:14 p.m.
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Date Reviewed: July 18, 2018, 12:30 p.m.
Anonymous: Fantastic instructor. The class materials were organized and presented well, but more time (2hr) for a repeat of this class is strongly recommended.
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Date Reviewed: July 17, 2018, 1:45 p.m.
Anonymous: should be 1.5-2hrs in duration. 1hr is too short
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Date Reviewed: July 17, 2018, 1:31 p.m.
Anonymous: A lot of really helpful information, but not enough time to go over it all. More time would really improve this session.
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Date Reviewed: July 17, 2018, 1:26 p.m.
Dina H: The instructor was AWESOME. Very engaging, interactive and informative. The content was relevant and clear. I wish the course was a bit longer so we could review more. Very useful overall.
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Date Attended: July 17, 2018, 11:56 a.m.
Date Reviewed: July 17, 2018, 1:26 p.m.