ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials

Contact: Office of Clinical Trials
Date: 2003-03-31

Expedited Reporting Summary Form

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?
Yes
No

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? 
Yes
No
If yes , date of  previous report (s):

Reported ADR occured in:

Phase I - III study

Phase IV study

Spontaneous ADR

ADR Country of Origin

Canada
Other

Has the drug been or is it currently marketed in Canada?  If yes, provide DIN.

DIN:

Has the drug ever been released under the Special Access Programme/ Emergency Drug Release?
Yes
No

Is there a clinical trial application for this drug under review in Canada?
Yes
No

Is there a new drug submission for this drug under review in Canada? 
Yes
No

ADR Reports must be provided by the following deadlines:

Fatal and Life Threatening Unexpected ADRs

1. Initial Report within 7 calendar days
2. Comprehensive Report within an additional 8 calendar days

All Other Serious and Unexpected ADRs

1. Comprehensive Report within 15 calendar days

Signature:

Date:

For Pharmaceutical Drugs: Please fax to: (613) 941-2121:
For Biologics and Radiopharmaceuticals: Please fax to: (613) 957-0364