Quality Assurance for Clinical Trials

The CCCR 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 program conducts internal file Reviews which verify that research studies are conducted and data is generated, documented and recorded in compliance with the study protocol, applicable regulations, standard 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 program also supports the research community by providing standard tools and processes.

For additional information about QA and Regulatory Compliance services, please contact our office.