Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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BRITISH COLUMBIA
• Knowledge Translation: Library Services, publication support [9 FTE].
Quality control/ assurance procedures are based on Health Canada and FDA regulations. The Department
of Evaluation and Research Services produces and makes available a Research Quality Improvement
Manual which lays out the process for ongoing monitoring of research studies. All projects are
approved by the Fraser Health Research Ethics Board prior to initiation.
Fraser Health is a participant in the Clinical Research Professional Development (CPRD) Education Program
(described in Appendix 5). This has a curriculum directed to research coordinators and is coordinated
amongst the Lower Mainland academic health centres.
Contact:
Chunick, Susan. Director, Department of Evaluation and Research Services. Tel: 604-587-4681. susan.
chunick@fraserhealth.ca.
Vancouver Coastal Health
Vancouver Coastal Health Research Institute (VCHRI) Clinical Research Unit
The VCHRI Clinical Research Unit (CRU) (www.vchri.ca/s/CRU.asp) is based at the Gordon & Leslie Diamond
Health Care Centre. It supports investigators in all disciplines at Vancouver Coastal Health and
UBC in their conduct of clinical trials. Investigators request CRU services for industry Phases II, III, and IV
trials, grant funded trials, or investigator-initiated research. Fees for services are based on the complexity
of the services requested and funding for the research The CRU offers:
• Assistance with protocol development
• Develop informed consent documents
• Recruiting
• Screening and consenting subjects
• Study interviews
• Venipuncture and serum and plasma aliquot preparation
• Physical exams and tests
• Vaccine and medication administration
• Adverse event reporting
• Subject appointment booking and reminder calls
• Monitor audits
• REB submission assistance
• Regulatory support with Health Canada/ FDA
The Unit supports all CFRI researchers as needed. Many of these are listed in Appendix 6. The unit is new
and growing. Current staffing is as follows (total = 2), with an anticipated two to four additional coordinators
to be hired by the summer of 2010.
Study Nurses/ Coordinators
Data Managers/ Coordinators
Laboratory & Pharmacy
Staff
Admin. (Clinical
Research Managers)
Epidemiologists/
Statisticians
1.5* 0 0 0.5 Collaborate with
C2E2**
* Also involved in the administrative aspects of clinical trials (e.g., REB submissions, regulatory documentation), budgeting and accounts,
study design, and training of assistants.
** C2E2 is the Centre for Clinical Epidemiology & Evaluation at VCHRI (www.c2e2.vchri.ca/), which offers expertise in study design,
data collection and management, statistical analysis, systematic reviews, and health economics.