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Contact: Office of Clinical Trials
Drug Code, Generic, or Brand Name:
Sponsor of Clinical Trial:
(CR) File Number:
Report Submitted By:
Contact Name and Telephone Number:
Protocol Title / Protocol Number (if applicable):
Sponsor's Identification Number for the case:
Date of ADR Onset:
Fatal or Life-Threatening Unexpected ADR
All other serious and unexpected ADRs
Is there an ongoing clinical trial for this drug in Canada?
For detailed information on adverse drug reactions subject to expedited reporting refer to part c division 5 of the food and drug regulations and e2a 'clinical safety data management: definitions and standards for expedited reporting' HC / ICH Guidelines, 1995
Is this a followup to a previous report?
If yes , date of previous report (s):
Reported ADR occured in:
Phase I - III study
Phase IV study
ADR Country of Origin
Has the drug been or is it currently marketed in Canada? If yes, provide DIN.
Has the drug ever been released under the Special Access Programme/ Emergency Drug Release?
Is there a clinical trial application for this drug under review in Canada?
Is there a new drug submission for this drug under review in Canada?
ADR Reports must be provided by the following deadlines:
Fatal and Life Threatening Unexpected ADRs
All Other Serious and Unexpected ADRs
For Pharmaceutical Drugs: Please fax to: (613) 941-2121:
For Biologics and Radiopharmaceuticals: Please fax to: (613) 957-0364