Clinical Trials Administration

The VCHRI Clinical Trials team assists the Vancouver Coastal Health (VCH) research community in bringing innovative therapies to patients by offering support services to investigators and sponsors to enable the conduct of high quality clinical research, including facilitating pharmaceutical and device research within hospital and university environments. The Clinical Trials team supports VCH researchers throughout the lifecycle of a clinical trial, from study assessment and start up phases, through to study conduct and closure.

The Clinical Trials team offers a variety of services, including:

Contract Facilitation

Responsibility for handling agreements related to sponsored research is distributed across various University of British Columbia (UBC) and hospital research institute administrative offices. The Clinical Trials team reviews agreements for industry initiated clinical trials, including confidentiality agreements, master clinical trial agreements, service agreements with third party service providers, equipment agreements and amendments. Data sharing agreements and compassionate use request agreements are also reviewed by the Clinical Trials team.

Quality Assurance

The Clinical Trials team develops programs and resources to ensure the quality of clinical trials conducted at VCH, including the development and maintenance of institutional standard operating procedures and quality management systems for clinical trials. Education and training is required prior to the initiation of each sponsor-initiated and investigator initiated clinical trial.

Clinical Trials Management System

VCHRI is a participating site of the provincial Clinical Trials Management System (CTMS), a program administered by the BC Academic Health Science Network. The CTMS program offers improved efficiencies at the research site level, while helping to ensure compliance with regulatory requirements. All VCHRI clinical trials are eligible to participate in the CTMS program.

RealTime CTMS at VCHRI

Budgeting and Financial Management

Researchers are responsible for creating a budget covering all expenses related to the conduct of a clinical trial at VCH. The Clinical Trials team offers services to help guide researchers in the creation of a comprehensive budget, taking into account hospital department fees and institutional overhead, as well as supporting researchers in the negotiation of study budgets with pharmaceutical and medical device companies.

Regulatory Guidance

Researchers must conduct clinical trials in compliance with all applicable laws and regulations, as well as clinical trial standards. The Clinical Trials team provides regulatory consults and delivers the Clinical Trials Activation Program to assist researchers in understanding regulatory requirements and obligations as a regulatory sponsor or site investigator.

Operational Research Approval

The Clinical Trials team is responsible for managing the VCH operational research approval process. The Clinical Trials team assists researchers in navigating the application process, including connecting researchers with key operational contacts within VCH. The VCH operational research review process is required for all human subject research conducted within VCH facilities or with VCH resources.

Research Privacy and Data Management

The Clinical Trials team collaborates with the VCH Data Release & Access Management Office (DRAMO) to provide research privacy support services to ensure that privacy is embedded into the design of all research projects. Research data management needs are supported through VCHRI’s partnership with UBC’s Digital Solutions, as well as services provided by VCH’s DRAMO.