/ Human Research Protection
Institutional Review Board
Serious Adverse Event Report Form

REPORTING REQUIREMENTS

  • Only report adverse events that are: Serious AND Unexpected AND Related (See definitions below)
  • Report them within 10 days after the investigator becomes aware of the event
  • Report all related deaths within 48 hours of receipt of the information
  • Only report event which are Possibly, Probably and Definitely related to the study product or procedures
  • Use this Serious Adverse Event Form
  • If the event is not reportable to the IRB, it may still need to be reported the sponsor of the study

Please note—The PI or their designee is required to sign the SAE event form report. Please ensure that the PI designee is delegated to this responsibility on the study delegation log.

DEFINITIONS

Serious Adverse Event

Any adverse event associated with the use of the drug/device or research interventionwhich results in any of the following outcomes:

death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above. (See reason for reporting the SAE on the SAE Form)

Unexpected Adverse Event

Any adverse event associated with the use of the drug/device or research intervention, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information provided to subjects (in the Informed Consent Document) and the IRB. Please note that the natural progression of a subject’s underlying disease, disorder or condition is “expected.” (See Additional Information on the SAE Form)

Related

There is a reasonable possibility, in the opinion of the Principal Investigator or the sponsor that the event was likely to have been caused by the research procedures. (See Attribution/ Causality on the SAE Form)

/ Human Research Protection
Institutional Review Board
Serious Adverse Event Report Form
Reportable SAE’s must be unanticipated and related

Principal Investigator: Today’s Date: IRB Number: Short Title:

Date of Report/ Notification / Subject enrolled atMMC? / Mfr. Report # /Subject Study ID # / Event Name / Initial or
Follow-up
Report / Reason for reporting SAE* / Attribution/ Causality** / Additional Information ***
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#
Y / In FU#

______/______

Signature of Principal Investigator / Designee Date

FOR IRB USE ONLY / Reviewed By: Date:
Is further action necessary?

Please send complete form and attachments to the Research Compliance Office at 81 Research Drive, ScarboroughMaine04074

(interoffice mail or fax (207) 396-8141)

Page 1 of 1 / SOP # RR 404-C Effective Date 9/21/2011 Supersede 10/01/2010