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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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