13. Forms

Hyperlinks to PDF versions of the below relevant forms and templates, including instructions for completion, and useful internet websites, are available under the heading “Forms and Templates” within the Health Canada website:  

• Adverse Drug Reactions (ADRs) for Clinical Trials – Expedited Reporting Summary Form
• Checklist for Submitting Requested Development Safety Update Reports (DSUR) in Electronic Format
• CIOMS Form I (Council for International Organizations of Medical Sciences)
• Clinical Trial Site Information
• Qualified Investigator Undertaking
• Research Ethics Board Attestation

Guidance regarding the completion and submission of specific forms is available under the heading “Instructions for Completing Forms/Templates”.