Problem Summary Sheet
Mail or deliver all IRB materials and correspondence to UAB Office of
the IRB.
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On-campus: AB 470, ZIP 0104
Off-campus: 701 20th St. S., Birmingham, AL 35294-0104
You are applying for continuing or final review and are summarizing all "reportable problems" since the inception of the
study. Your application must also include the Investigator's Progress Report.
In Table A, include all "reportable problems" as defined on the Problem Report in Table A.
In Table B, include problems that do not meet the UAB criteria for "reportable problems" but for which the sponsor requests IRB
notification.
Principal Investigator:
UAB IRB Protocol No.:
Sponsor:
UAB IRB Protocol Title:
Table A Date of
Sequence Report
Dates Covered:
Inception Date:
Sponsor Protocol No.:
Study Drug/Device:
to
Table A: “Reportable Problems” Already Reviewed by the UAB IRB
Participant ID
Brief Description of Problem
Date Acknowledged by the IRB
1.
Table B Date of
Sequence Problem
Table B: Problems NOT Meeting the UAB Criteria for "Reportable Problems"
BUT Sponsor Requests IRB Notification
Participant ID
Brief Description of Problem
Is the Problem Related to the
Drug, Device, Protocol, or
Intervention?
1.
234 - problem-summary.doc
4/18/07
Yes
No
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