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Unexpected Problem Report
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Unexpected Problem Report
Contact Information
First name
Last name
Email
Phone
Area Code
Phone Number
Protocol Information
Protocol title
IRB Protocol number
Principal Investigator(s)
PI first name
PI last name
PI email
PI phone
Area Code
Phone Number
Co-PI first name
Co-PI last name
Co-PI email
Co-PI phone
Area Code
Phone Number
Date Reported
Date report was submitted to the IRB
Month
-
Day
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Year
Information on the Unexpected Problem
Describe the unexpected event(s)
Include all details such as the nature of the problem, the number of events, the dates of occurrences, number of participants involved, known or potential impact on participants, and any other relevant information.
Describe the known or possible cause(s) for the event(s)
Describe the actions, if any, that research team members, and/or others took in response to the event