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Forms & Guidance

Click on the links below to view or download PDF versions of the Forms and Guidance Notes concerning Behavioural and Clinical policy and procedures.

Behavioural Forms & Guidance Notes

Application
Guidance Note on Behavioural ApplicationUpdated March 2013
Behavioural Human Ethics Application (for review purposes only)
Please click on the link below to actually complete the application.
Application for Behavioural Ethical Review

Consent
Behavioural Consent Form Guidelines

Clinical Forms & Guidance Notes

Application
Clinical Human Ethics Application (for review purposes only)
Please click on the link below to actually complete the application.
Application for Clinical Ethical Review

Consent
Informed Consent Template Updated Sept 2013
         Summary of Changes to Consent Form Template Updated Sept 2013
FDA Issues Guidance on New ICF Requirements

          Q&A on ICF Elements 21 CFR &50.25

FDA Wording Clarification in the ICF Template


New Applications
Guidance Notes for Clinical Research and RISe Application
Guidance Notes for Minimal Risk Studies
Guidance Notes for Tissue Collection and Banking

Guidance Notes for Radiation Exposure (DRAFT)

Guidance Notes for Harmonized Studies

Post Approval Activities

Guidance Notes for Annual Renewals
    Failure to Comply with Requirements for Annual Renewal

    Fee for Annual Renewal
Guidance Notes for Amendments
Guidance Notes for Request for Acknowledgement
Guidance Notes for Notification of Study Closure
Guidance Notes for Protocol Deviations
Guidance Notes for Reporting Unanticipated Problems
UBC Policy on Reporting Unanticipated Problems
       Sample of Basic Periodic Safety Summary Report

Other Resources

Checklist for Quality Improvement, Quality Assurance
PHC RI Plain Words Watch List
PHCRI Plain Language Research Tips
Plain Language Research Glossary
Alternate Word Glossary (University of Western Ontario)
Plain Language Medical Dictionary (University of Michigan)
Group Health Institute's Program for Readability in Science & Medicine

Engaging Limited English Proficient Participants

Tips for Working with an Interpreter

Steps for Translating Research Materials

Invite to Participate Templates

Chinese Traditional (Cantonese)

Chinese Simplified (Mandarin)

Vietnamese

Punjabi

Notices
UBC REB Policy on Electronic Signatures

Stamped Approval on Consent Forms