UNANTICIPATED PROBLEM/EVENT REPORT FORM
Report of Problems, Injuries and Events that Require Prompt Reports to JHSPH IRB
DO NOT USE THIS FORM TO REPORT ANTICIPATED EVENTS OR MINOR/ADMINISTRATIVE DEVIATIONS
Institutional Review Board Office
615 N. Wolfe Street / Room E1100
Baltimore, Maryland 21205-2179
Phone:
410-955-3193
Toll Free: 1-888-262-3242
Fax:
410-502-0584
Email:
jhsph.irboffice@jhu.edu
Website: www.jhsph.edu/irb
Use this form to report any problem or event that: 1) poses harm or risk of harm to subjects or
others; 2) is unanticipated (not described in research plan or consent form); and 3) related to
the study procedures. NOTE: “Prompt reporting” means submission within 10 working days of
learning about the unanticipated problem.
IRB Number:
Principal
Investigator:
Signature of PI:
Date:
Phone:
E-mail:
Study Title:
Sponsor:
A. Type of Problem/Event
Is the problem/event you wish to report one that involves (select all that apply):
1. Risk of harm to individual participants in the study and associated with study operations (Fill out Section B and C
below.)
2. Social/political developments that affect the risk of harm to participants or to study staff (Describe below and
provide details about any steps taken to minimize risk).
3. Other problem/event that could affect study operation and safety of participants or study staff (Describe below and
provide details about any steps taken to minimize risk).
B. If you selected 1 above, describe the problem/event/injury to the participant below
1.
Participant identifier
2.
Date problem/event occurred
4.
Briefly describe the problem/event (Use as much space as you need. Box will expand.)
5.
Did the problem/event cause harm or place the participant or a non-participant at
increased risk of harm? IF YES, describe below
Unanticipated Problem/Event Report Form
19Apr2015
Age:
Gender:
Male
Female
3. Date problem/event
discovered
1
Yes
No
6.
Does the study include a drug or device used in a clinical investigation?
IF YES, provide name of drug or device below
7.
Have any corrective actions been taken by the study team to date?
IF YES, describe them and their outcome. Indicate any that were undertaken without prior
approval by the IRB. (Use as much space as you need. Box will expand)
Yes
Yes
No
No
C. If you selected 1 above, answer the following questions
1.
Are the specificity, frequency and severity of the problem consistent with the protocol and
consent document?
Yes
No
2.
Is it more than likely than not that this problem event was related to the research procedures
or interventions?
Yes
No
IF YES, and the project involves a drug or device, check below the strength of the
relationship of the drug/device to the problem/event:
Not related
Probably not related
Possibly related
Probably related
Definitely related
3.
Is it more likely than not that this problem/event will affect future research procedures or
interventions in this research? IF YES: Explain:
Yes
No
4.
Should the consent document be revised?
IF YES: submit an amendment request and revised consent form with track changes
Yes
No
5.
Should the research plan (and/or Sponsor’s protocol) be revised? IF YES: submit an
amendment request and revised research plan/protocol with track changes
Yes
No
6.
Should the research be suspended?
IF YES: Explain procedures for orderly suspension or termination of the research
Yes
No
7.
Should currently enrolled participants be notified about this problem/event?
IF YES, submit a draft notification letter/document with this report.
Yes
No
8.
Is there a DSMB for this project?
IF YES, submit a copy or summary of the DSMB review of the event with this report
Yes
No
9.
Have either of the following entities been notified about the problem/event?
IF YES: check which have been notified:
Yes
No
Sponsor
Unanticipated Problem/Event Report Form
19Apr2015
PI holds IND/IDE and has notified FDA
2