Clinical Trials BC launches phase two of QMS Program
By Jean Smart, Regulatory Affairs and Quality Officer
Quality in research has been a requirement for two decades. The revised International 2016 Good Clinical Practice document known as ICH E6R2, which replaces the twenty-year-old version, is far more descriptive of the requirements for quality and risk management components at the institution, program and site levels. It comes into full effect as regulation in Canada on April 1, 2019.
Setting up a quality environment in a research institution, centre or program, where none exists, can seem a very daunting task. Clinical Trials BC (formerly BCCRIN), under the BC AHSN, identified the arduous challenges associated with individual institutions implementing quality systems and has led to establish an accessible Quality Program for BC researchers and institutes.
Clinical Trials BC’s provincial approach provides research organizations, programs or centres with nine pre-developed
quality management systems (policies, SOPs, forms, trackers) and supporting tools (manuals, development plans),
designed to be adaptable to the institution.
The main objectives of the QMS program are to strive for continuous quality improvement, promote regulatory compliance and foster a quality culture. These objectives are achieved through a structured quality framework based on an education and resource model. With the launch of phase two, the program now includes leadership training, access to quality and compliance education modules, full system resources, quality community support and ongoing assistance with the development and implementation of the systems.
- In 2019, watch for:
- Joining of a second group of institutions upon phase 2 implementation of QMS – winter 2019.
- Launch of a quality community of practice
- Opportunities to sign up for Risk Management V2 resources and workshops
Clinical Trials BC is committed to creating and maintaining a quality research culture and promoting quality programs and systems.
The Clinical Trials BC Quality Management System Program offers services, resources and support for the development and implementation of Quality Management Systems (QMS) in centres, institutions and agencies. The program includes:
- QMS Leader training
- Development and implementation planning
- QMS systems and tools
- Community of practice
- Mentorship and ongoing support
To join the QMS Program in BC, please contact us.