ALBERTA CANCER RESEARCH Date received:
Research Ethics Office
Suite 1500, Sun Life Place Signature of ACREC Chair (or designate):
Edmonton, AB T5J 3H1
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:
Patient Type Relation to
Report or Study
No./Initials or Event (Initial, Study
Date* Unexpected Medication
Report No. F/up) Medication
*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.