Quality Assurance for Clinical Trials

The Office of the Vice-President (Research) created a new position that provides Quality Assurance (QA) and Regulatory Compliance services for the research community to ensure that all clinical research meets high-quality standards and ICH Guideline for Good Clinical Practice and applicable regulations are followed in the conduct of clinical trials.

The QA and Regulatory Compliance Specialist assesses research quality through Quality Assurance File Reviews, which verify that research studies are conducted and data are generated, documented and recorded in compliance with the study protocol, applicable regulations, standards operating procedures and institutional policies.

 

The University of Calgary, through its membership with N2, provides access to CITI’s online training as well as access to their complete set of Clinical Research Standard Operating Procedures (SOPs). The QA and Regulatory Compliance Specialist also supports the research community  by developing and implementing  standard tools and processes.

For additional information about our services, please contact Linda Longpre, at linda.longpre@ucalgary.ca or 403-220-6470.

Resources


Tools and templates

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Standard Operating Procedures (SOPs)

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Training and education

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Regulations, guidelines, important links

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N2 Canada: Network of Networks

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Memo archive