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
Jhsph.irboffice@jhu.edu
615 N. Wolfe St, Suite E1100
Baltimore, MD 21205
Phone: (410) 955-3193
Fax: (410) 502-0584
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. Unanticipated harm or risk of harm to individual participants in the study as a result of study participation. Complete
sections B and C below.
 2. Social/political developments beyond the PI’s control that pose harm or 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 not associated with study participation that poses harm or risk of harm to study staff or study
integrity (e.g., loss of study data, transport accidents, etc.) 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
1Dec2015
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
 Yes
 No
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
 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?
2.
Please assess below the relatedness of the problem event to participation in the research.
 Not related
 Probably not related
 Possibly related
 Probably related
 Yes
 No
 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
1Dec2015
PI holds IND/IDE and has notified FDA
2