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Charles R. Drew University of Medicine and Science

Office for the Protection of Human Subjects

Institutional Review Board

Internal Adverse Event Report

Instructions to the Investigators:

  • Use this form to report adverse eventsand subject deaththat occurred at CDU or other site where CDU is the IRB of Record.
  • Immediately upon awareness of the adverse event, please use the checklist below to determine when to report to CDU IRB.
  • Please check with the study sponsors and other oversight entities (Data and Safety Monitoring Boards/Data Monitoring Committee, data coordinating center, biosafety committee, etc.) about their reporting requirements.

Checklist to Determine Mandatory Reporting to CDU IRB / Timeframe of Mandatory Reporting to CDU IRB / Guidance
Subject Death
Research activity involves intervention or interaction with the participants (includes socio-behavioral studies)
Death was unexpected
Related or possibly related to participation in the research / If you checkedall3 boxes to the left,fill in the rest of this form and submit to .
You must submit thereport within 3 working days of awareness to the CDU IRB. / Report during continuing review,
if death was expected and related or possibly related to participation in researchand research activity involves intervention or interaction
Otherwise, do not submit to IRB
Adverse Event (AE) that is an
Unanticipated Problem
This is an adverse event (physical or psychological in nature)
AE was unexpected OR AE was expected but indicates a higher frequency or severity than was previously known or described in the IRB approved informed consent
Related or possibly related to the research activity
Serious or suggest that the research places subjects or others at greater risk of harm than was previously known or recognized / If you checkedall4 boxes to the left,fill in the rest of this form and submit to .
You mustsubmit thereport within 5 working days of awareness to the CDU IRB. / Report during continuing review, if you did not check all the boxes.The adverse event is not considered an unanticipated problem.
*If you are a sponsor/investigator (i.e., IND or IDE holder), you must also report to FDA promptly.
  1. Project Information

Date of Report:
CDU IRB #:
Project Title:
Principal Investigator of the IRB application:
Person completing this form and relationship to the
project:
Contact information(phone #, e-mail):
Number of subjects approved to be enrolled:
Number of subjects enrolled to date:
Number of reportable adverse events to date:
Research involves:
Drug
Device / Name of Drug, Dosage and Manufacturer:
Name of Device and Manufacturer:
Vulnerable subject population: / Children
Prisoners
Pregnant women, fetus, neonates
Other: Describe: ______
Study participant status: / On-going intervention or interaction with participants
Participants are receiving follow-up visits or procedures
Intervention or interaction have been completed
Enrollment status: / Open to enrollment
Closed to enrollment
No participants have been enrolled
  1. Adverse Event Information

Type of report: / Initial Follow-up Final
Date adverse event (AE) occurred:
Date investigator became aware of AE:
Study participant ID number:
Location where AE occurred:
Current AE status: / Resolved or resolving as expected
Chronic Condition
Death
Unresolved (follow-up report must be submitted to the IRB)
  1. Adverse Event Classification

Relationship to the research: / Possibly related. Explain:
Related. Explain:
Seriousness of the event (check all that apply): / Death
Life-threatening
Inpatient or prolonged hospitalization
Persistent or significant disability/incapacity
Congenital anomaly/birth defect
Emotional/Psychological Harm
Other medical conditions, such as cancer
Require intervention to prevent permanent impairment/damage
Other. Explain:
Was the event foreseeable or expected natural progression of any underlying disease, disorder, or condition of the participant? / Expected, but not described in the IRB application, research protocol, or consent document
Unforeseen
More serious/severe than expected
More frequent than expected
  1. Description of Adverse Event and Treatment

Please describe the adverse event or participant’s death. Include description of signs and symptoms that may be related to research and clinical diagnoses.
Describe any treatment provided to the participant and date administered.
Please provide candid discussion on why the adverse event might have occurred (participant’s unexpected withdrawal from the study, protocol deviation, overdose of study medication, etc.)
Did a similar event occur previously in this study? If so, how many times in the past?
  1. Adverse Event with Significant New Findings

Changes to theResearch Protocol
Does this AE involve significant new findings that a change in protocol is necessary to reduce or eliminate risk? / Yes. Submit an addendum to change the research protocol.
No. Explain:
Changes to the Consent Document
Are any changes required in the informed consent documents to better inform and protect the rights and welfare of the subjects? / Yes. Submit an addendum to change the consent document. No new subjects may be recruited or enrolled until the revised consent form is approved by the IRB.
No. Explain:
Re-consent
It is necessary to inform participants/legally authorized representatives (LARs), who have already consented to participate in the study, of the adverse event? / Yes. Submit an addendum to change the research protocol and consent document.
No. Explain:
How will the previous and current participants be informed of significant new finding(s) once IRB has approved the revised research protocol and consent document? / Please explain.
How will the participants be re-consented after IRB approves the revised consent document? / Please explain.
  1. Compliance

What other entities did you report the adverse event?
Sponsor FDA DSMB CTRC IBC Other. Specify:
If you are submitting this initial internal AE report after 5 days of discovery (or 3 days of discovery of fatal event), please explain the following:
  1. Why is the report submitted late?

  1. What new procedures are in place to avoid late reporting in the future?

  1. Investigator’s Certification

I have reviewed the adverse events and certify that the information above reflects my conclusions.
Name of Investigator / Role in the Study
Signature of the Investigator / Date Signed
In the event that the Principal Investigator is not available, a physician co-investigator may sign. If the PI is not a physician, a study physician co-investigator must sign.

Office Use Only (please do not write below)

IRB Staff Review
Additional review required? / No. Does not meet submission criteria
No. Other reasons. Specify:
______
Yes, by IRB Chair/Vice Chair Review
Yes, by another. Specify:
______
Reviewed by: / Date reviewed:
IRB Chair/Vice Chair or Physician Designee Review
This is an unanticipated problem (unexpected, related or possibly related, places subjects/others at greater risk or harm than previously known) / Yes, need review by full Committee
No, full Committee review not required
Additional information or action needed? / No
Yes. Specify:
Reviewed by: / Date reviewed:

Rev. 6/2015aForm 129a