Vancouver Coastal Health Research Institute (VCHRI) is committed to raising the standards of clinical research at VCH and therefore human research participant protection, through education, process improvements, internal quality assurance and regulatory compliance. To demonstrate this commitment, VCHRI—with guidance from the BC Clinical Research Infrastructure Network—is developing a research quality program that will include a robust Quality Management System (QMS). A QMS will help to ensure that quality is built into all operational aspects of clinical research.
The VCHRI QMS will comprise of the following subsystems:
- Document Management System
- Site Corrective Action / Preventive Action (CAPA) System
- Continuous Quality Improvement System
- Audit System
- Investigation System
- Deviation System
- Training and Site Qualification System
- Vendor Qualification and Surveillance System
The Research Quality program undertakes the responsibility of maintaining and implementing established institutional level documents, such as the clinical trial Standard Operating Procedures (SOPs). We also offer guidance and tools to ensure that all clinical research projects and trial activities are conducted in a manner consistent with regulatory requirements. Our goal is to help ensure the rights, safety, and well-being of participants and the scientific integrity of the research.
VCHRI researchers and their research team members may access VCHRI SOPs, guidances, and tools with a username and password on the VCHRI website: http://www.vchri.ca/user.
Who does it affect and how does it affect them?
The institution-level documents as well as the QMS detail the essential elements of research standards as well as the requirements expected of researchers within VCH.
We are committed to helping our sponsor-investigator(s) and qualified investigator(s) comply with the research principles, procedures, and guidelines outlined above. Please contact our Research Quality Coordinator, Patrick Altejos for additional information on these procedures and more information about our services and supports.
Patrick Altejos is available to provide reviews and consultation on the development and implementation of your research program’s SOPs. He can also help establish a QMS for your research area.