HUMAN RESEARCH PROTECTION INSTITUTIONAL REVIEW BOARD SERIOUS ADVERSE EVENT

 HUMAN TISSUE AUTHORITY WRITTEN EVIDENCE TO THE HOUSE
ANTEPROYECTO ANTEPROYECTO PORQUE ESTA GRAN HUMANIDAD HA DICHO
FACULTAD DE HUMANIDADES Y CIENCIAS DE LA EDUCACIÓN DEPARTAMENTO

FACULTADESCUELA DE HUMANIDADES Y CIENCIAS DE LA EDUCACIÓN DEPARTAMENTO
10 HANSJOSEF VOGEL BÜRGERMEISTER „WEITERBILDUNG UND (HUMANITÄRE)
APPLICATION FOR DESIGNATION OF NOT HUMAN SUBJECTS

SERIOUS and/or UNEXPECTED ADVERSE EXPERIENCE FORM

HUMAN RESEARCH PROTECTION INSTITUTIONAL REVIEW BOARD SERIOUS ADVERSE EVENT

Human Research Protection

Institutional Review Board

Serious Adverse Event Report Form



REPORTING REQUIREMENTS



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 intervention which 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

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 at MMC?

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#      

     

     

     

* Reason for Reporting SAE

1 Fatal

2 Life threatening, but not fatal

3 Resulted in permanent disability

4 Required inpatient hospitalization

5 Prolonged an inpatient hospitalization

6 Resulted in congenital anomaly or birth defect

7. Other: Serious/ Important Medical Event


*** Additional Information, such as:

** Attribution/ Causality 1 Definitely Related

2 Probably Related / Likely

3 Possibly Related






NOTE: Investigators holding their own IND may need to amend the Informed Consent Form and Protocol.




__________________________________________________/_______

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, Scarborough Maine 04074

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

Page 2 of 1

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



CENTRE FOR HUMAN RIGHTS –NIS SERBIA INDIVIDUAL CONTRIBUTION
CHAIR COMMISSIONERS JACK SHUMAN SARAH BAKER VICE CHAIR
EL DEPARTAMENTO DE RECURSOS HUMANOS U


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