Quality Resources

Research Standards and Regulations

Health Canada

Inter-agency Advisory Panel on Research Ethics

International

United States

U.S. Food and Drug Administration

Resource Documents and Tools:

Institutional Accreditation Certificates:

Standard Operating Procedures & Guidelines:

The Research Quality Program is pleased to introduce and release several institutional Standard Operating Procedures for Health Canada regulated clinical trials. The goal of these SOPs is to provide consistency and efficiency for research groups. 
 
Please see the attached SOPs:
 
It is recognized many groups have created existing departmental SOPs. Research teams are not required to replace their current SOPs with the attached institutional SOPs provided their current SOPs contain the components as described in the attached institutional SOPs. 
 
We will be creating more SOPs over the next few months. Our aim is to create SOPs that are required for ICH-GCP  compliance within Health Canada regulated clinical trials and also to align REB and institutional requirements.
 
Non-regulated clinical trials are encouraged, not required, to have SOPs in place. These trials must be able to show, in the Ethics Application Form for REB submission, that their consenting and privacy practices align with TCPS and privacy legislation. Feel free to adopt any of the Health Canada institutional SOPs or use them as a guide for completing appropriate sections in the EAF for REB submission.
 
For more information please contact Michele Chappell, Program Manager, Research Quality, at Michele.chappell@nshealth.ca or 902-478-2162.
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