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Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP<br />

101<br />

Contact:<br />

Krajden, Mel. Associate Director, Laboratory Services. Tel: 604-707-2421. mel.krajden@bccdc.ca.<br />

Mei, Wendy. <strong>Clinical</strong> <strong>Trials</strong> Coordinator. Tel: 604-707-2643. wendy.mei@bccdc.ca.<br />

Fraser Health Authority<br />

Fraser Health Research & Evaluation<br />

Fraser Health (www.fraserhealth.ca) is a publicly funded regional authority that oversees the provision<br />

of all publicly funded health services at its owned <strong>and</strong> operated acute <strong>and</strong> community sites. It provides<br />

a wide range of integrated health care services to more than 1.5 million people living in communities<br />

stretching from Burnaby to White Rock to Hope. Its health care services range from 12 acute care hospitals<br />

to community-based residential, home health, mental health, <strong>and</strong> public health services.<br />

The Department of Evaluation <strong>and</strong> Research Services (http://research.fraserhealth.ca/home/) aims<br />

to establish Fraser Health as a premier site for the conduct of clinical, health services, <strong>and</strong> population<br />

health research, such that new knowledge is created <strong>and</strong> translated into policy <strong>and</strong> practice to enable<br />

“best in health, best in health care” for patients, clients, <strong>and</strong> residents. The Department supports 15 full-<br />

<strong>and</strong> part-time personnel <strong>and</strong> two Michael Smith Foundation for Health Research (MSFHR) grant funded<br />

‘Research Team Planning Strategists’. It provides services across all Fraser Health sites.<br />

Over 2,300 physicians provide services in Fraser Health facilities. Physicians who wish to participate in<br />

clinical trials as a site investigator are not employees of Fraser Health, but must have privileges with<br />

Fraser Health. Physicians are only allowed to conduct research at hospital sites for which they have<br />

privileges. Both physicians <strong>and</strong> Fraser Health are a party to contracts with industry <strong>and</strong> academic sponsors.<br />

The Department of Evaluation <strong>and</strong> Research Services supports Phase II, III <strong>and</strong> IV therapeutic <strong>and</strong> device<br />

clinical trials, as well as behavioural, investigator-initiated <strong>and</strong> grant funded studies. Details about 50<br />

investigators who conduct clinical trials can be found in Appendix 6. The following types of services<br />

<strong>and</strong> support is listed below with staffing indicated in parentheses.<br />

• Health Research Intelligence Unit: Methodology <strong>and</strong> Biostatistics Services, including research<br />

project/protocol development, study design <strong>and</strong> methodology, budget development, statistical<br />

analysis, data management, <strong>and</strong> grant administration [Epidemiologist <strong>and</strong> Research/Grant Development<br />

Facilitator – 2 FTE]<br />

• Ethical Review: Assistance with REB submissions, education, <strong>and</strong> site monitoring oversight [Research<br />

Ethics Coordinator]<br />

• Research-related services provided by Research Coordinators, funded by individual FH departments,<br />

provide integrated support to individual research studies, co-ordinate all applicable approvals<br />

for the provision of service by their department, <strong>and</strong> liaise with investigators <strong>and</strong> others as<br />

required during studies: Laboratory Services [1 staff ]; Pharmacy Services [1 staff ]; Perinatal Services<br />

(patient recruitment <strong>and</strong> samples management); <strong>and</strong> Health Records [1 FTE].<br />

• Administration of clinical trials registration at clinicaltrials.gov<br />

• Contract Review: Contract negotiation conducted by the University of British Columbia Industry<br />

Liaison Office on behalf of Fraser Health<br />

• Overall co-ordination of all approvals required for the conduct of research in FH.<br />

• Education <strong>and</strong> Communication: Coordinated by Department of Evaluation <strong>and</strong> Research Services<br />

[1 staff ]. Includes: education in research methods (e.g. skill development workshops; training in<br />

ethical <strong>and</strong> regulatory requirements for clinical trials)

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