Protocol Deviation Reporting Form

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					                                   ALBERTA CANCER RESEARCH            Date received:
                                   ETHICS COMMITTEE

                                   Research Ethics Office
                                   Suite 1500, Sun Life Place         Signature of ACREC Chair (or designate):
                                   10123-99 Street
                                   Edmonton, AB T5J 3H1
                                   Phone: 780-643-7123
                                          780-643-7124                For office use only

                    LOCAL SERIOUS ADVERSE EVENT REPORTING FORM

DATE REPORT PREPARED:                          PRINCIPAL INVESTIGATOR:


ACREC Project #, SPONSOR (if applicable), PROTOCOL NUMBER, TITLE:



Return Form to:

                                                          Expected
             Patient                         Type                              Relation to
Report                                                       or       Study
          No./Initials or     Event         (Initial,                            Study
Date*                                                    Unexpected Medication
           Report No.                        F/up)                             Medication
                                                            (E/U)




*Date of SAE or follow-up of SAE if available. IF industry sponsored study, this can be the date
of reporting to sponsor.

By return of this form, it is acknowledged that the ACREC (or Chair, on behalf of the
ACREC) has reviewed the above SAE Reports for safety.


TO BE COMPLETED BY THE QUALIFIED PRINCIPAL INVESTIGATOR OR DESIGNATE

Does the consent form or protocol require changes as a result of the above safety information?

[ ] Yes    [ ] No

If consent form or protocol changes are required, please submit revised copies to our office for
review and approval. Please ensure that all changes are highlighted.



____________________________
Principal Investigator Signature


PLEASE ATTACH CORRESPONDING EVENT DOCUMENTATION. IF THIS STUDY IS INDUSTRY
SPONSORED OR INVESTIGATOR INITIATED PLEASE REPORT TO REGULATORY AUTHORITIES
AS PER PROTOCOL AND/OR REGULATORY REQUIREMENTS.

				
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