Involving Risk to Subjects or Adverse Events
General Definition of Unanticipated Problem:
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are
described in the protocol-related documents, such as the IRB-approved research protocol and
informed consent document; and (b) the characteristics of the subject population being studied;
2. Related or possibly related to participation in the research (in this guidance document,
possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known or recognized.
General Definition of Adverse event:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subjects participation in the research, whether or not considered related to the subjects participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
For any questions, please refer to the IRB website or contact the IRB staff at or (714)628-7392.
Project Title:
/Project Title
Study Sponsor: / IRB# / Current IRB #Today’s Date:
/Today’s Date
/Most recent IRB Approval Date:
/Most recent IRB Approval Date
Chapman Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor):☐ / This is a Student-Directed Project and I am serving as Faculty Advisor
Name:
/PI Name or Faculty Advisor
/Email:
/Institute/Center/Department:
/Institute/Center/Department
School/College:
/Choose or type a School/College...
/Phone:
/Phone Number
Unanticipated problem or Adverse Event Details and Description:Subject Name or Number (if known):
/Subject Name/Number
Facility where complication or event took place:
/Facility Name
/Date of complication or event:
/Date of Event
Brief description of unanticipated problem or adverse event (including any applicable pre-morbid contributing conditions): Attach supporting documents from medical records, sponsor, etc. if applicable)
/Brief description of unanticipated problem or adverse event
☐Yes ☐No
/In the Investigator’s opinion, was the unanticipated problem or adverse event related to the project or study drug?
☐Yes ☐No
/Is the risk currently stated in the informed consent?
/If yes, attach a copy of the approved informed consent and highlight or underline the applicable risk.
☐Yes ☐No
/Should the protocol and/or informed consent be modified?
/If yes, describe what changes have been made and attach a copy of the revised informed consent (show revisions by highlighting or underlining changes)
/Describe changes to protocol and/or informed consent
CHECKLIST: Submit the following items with this Request for Modification:☐ / Copy of currently approved informed consent / ☐ / Revised copy of approved informed consent
☐ / Other supporting documents (from medical records, sponsor, etc.). Describe below:
Click here to enter text.
PRINCIPAL INVESTIGATOR’S ASSURANCE STATEMENT & SIGNATURE PAGE
This page is to be read and signed by the Faculty/Academic Professional Staff member acting as principal investigator or faculty advisor for a student-directed project.Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor)
By signing this document, I attest that all the information I have provided is accurate to the best of my knowledge. I certify that the rights and welfare of human subjects participating in this research project will be protected at all times and the benefits to be gained from this study are commensurate with the risks involved.
I certify that no changes have been made and that no changes will be implemented prior to IRB review and approval.
Name of Principal Investigator (Please Print)
Signature of Principal Investigator / Date
Principal Investigator’s Department Chair/Director/Supervisor
I certify that I have reviewed this request for modification to an approved project and that none of these changes have been made and that no changes will be implemented prior to IRB review and approval.
Name of Department Chair/Director/Supervisor (Please Print)
Signature of Department Chair/Director/Supervisor / Date
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Chapman University – Rev. Date: Dec. 2016 HS#______