Ended: Aug. 9, 2018
What is an unanticipated problem? Is it more than just an adverse event? When is it a deviation? When is it a violation? In this session, we will discuss events that constitute an “unanticipated problem,” regulations governing unanticipated problems and the requirements for reporting such events. In addition, we will discuss best practices for identifying, documenting, and reporting unanticipated problems to the IRB and sponsors according to the regulations and IRB Polices.
Participants are welcome to bring lunch. Registration is required. If you have any questions, please contact dcredu@partners.org
Programs: QI Bootcamp Beginner Clinical Research Coordinator
Category: Research Quality Improvement
Sponsor: MGH Division of Clinical Research
Sessions
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Aug. 9, 2018
08/9/18 12PM-1PM |
12 PM – 1 PM |
Garrod/Mendel, Floor 2, Simches Research Center
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