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
- What is Document Management System?
Document Management System (DMS) is one of the components of VCHRI's overall Quality Management System. DMS ensures compliance with institutional research quality guidelines that describes the methods VCHRI employ to manage its Controlled Documents such as institutional Standard Operating Procedures, guidance documents, forms and templates for clinical trials/research conducted at Vancouver Coastal Health.
VCHRI SOP 201 Change Order Request describes the procedures for managing changes to a VCHRI Controlled Document. Compliance with this procedure ensures that each change proposed is adequately defined, reviewed, analyzed and documented before implementation.
VCHRI SOP 202 Controlled Document Review outlines the process by which VCHRI Controlled Documents are reviewed and updated at regular intervals to ensure that they remain accurate and relevant to current standards of practice and regulatory requirements.
How to use it?
Any VCH research staff can request a change to a VCHRI Controlled Document. To request a change to a controlled document, review VCHRI SOP 201 Change Order Request, and complete VCHRI FORM F201: Change Order Request Form electronically then submit the completed form to VCHRI QA by email.
Content Reviewers are appointed by VCHRI to help review and approve proposed document changes. Content Reviewers can access VCHRI FORM F202: Change order Review Form (per SOP 201) or VCHRI FORM F204: Document Review Form (per SOP 202), and submit their review feedback to VCHRI QA by email.
- 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 Stephania Manusha 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.