Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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94 BRITISH COLUMBIA FIGURE A9. Centre for Health Evaluation and Outcome Sciences Research Administrative Coordinator & Bookkeeper John Orr Director of Operations Statisticians, Data Managers Database Developers, IT, Programmers, Data Entry Dr. Yvonne Lefebrve Vice President, Research & Academic Aairs Providence Health Care Research Institute Dr. Aslam Anis Director, CHÉOS Professor, School of Population & Public Health UBC Joel Singer/Hubert Wong Co-Department Heads, Statistics, Data & Methodology Erin Cherban Manager, Clinical Trial Support Unit Health Economist Clinical Research Project Managers The process for getting trials approved by the unit is as follows. Investigators from Providence Health Care contact CHEOS to request services. The requests are then evaluated by the appropriate departments, for example, the Director of Operations, the Department Head of Statistics and Methodology, or the Manager of the Clinical Trial Support Unit. Once approved, CHEOS assists with the requested service, for example study start-up, database design, data management and statistical analysis for the entire study. Quality control/ assurance procedures are based on Standard Operating Procedures compliant with Good Clinical Practice (GCP) guidelines. The unit also trains clinical trial personnel in clinical research procedures and GCP, and monitors local investigator-initiated clinical trials. CHEOS is a participant in the Clinical Research Professional Development (CRPD) team which has a curriculum of clinical research education for Lower Mainland health centres. All projects are approved by the REB prior to initiation. Contact: Orr, John. Director of Operations. Tel: 604-806-2294. johnorr@mail.cheos.ubc.ca. PHC Ethics Submission Coordinator Provincial Health Services Authority Child and Family Research Institute (CFRI) Clinical Research Support Unit The Child & Family Research Institute (CFRI) is dedicated to world-class research spanning a wide range of children’s and women’s health concerns. The Institute, based at B.C. Children’s Hospital, provides support for investigators conducting clinical research through its Administration and the Clinical Research Support Unit (CRSU) (www.cfri.ca/research_support/clinical_research_support/default.asp). The CRSU staff and faculty have expertise in epidemiology, statistics and economics, and provide support to clinician investigators including research project and program development, study design, data collection and management, and statistical analysis. A trials data management system includes a randomization module and ability to import images.
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 95 Among other services, the CRSU offers the following. Staffing is indicated in parentheses. • Methodology and Biostatistics Services, including research project development, study design and methodology, statistical analysis and data management (www.cfri.ca/crs/Biostatistics.asp) [3 staff; 4 faculty] • Data Management services that meet Health Canada and FDA requirements. CFRI investigators have access to a trials data management software platform, assistance in the design of forms and reports, and training of data entry staff. Data storage is managed on a secure platform by CFRI IT Services. This service supports about 1,000 studies a year [2 programmers, 1 trainer/form developer, 1 regulatory affairs manager to support SOP development] • Facilities including the B.C. Children’s Hospital Chieng Medical Day Unit, offering support for clinical trials requiring nursing care and monitoring during interventions; and the Clinical Research and Evaluation Unit for minimally invasive studies, providing eight exam rooms, wet and dry storage rooms, and a staff study-coordination room (www.cfri.ca/crs/researchclinic.asp) • Hospital Services Research Coordinators are in place to support individual research studies and liaise with investigators and others as required during studies, in Laboratory Services (www.cfri.ca/ crs/laboratoryservices.asp); Pharmacy Services to support research studies (www.cfri.ca/crs/pharmacy); Perinatal Services (patient recruitment and samples management); and Health Records (for chart retrieval, abstracting and audit purposes). [4 staff in total]. In addition to the Hospital Services Research Coordinators mentioned above, there are a large number of research program coordinators, the senior members of which are listed in Table A2. FIGURE A10. Structure of CFRI Human Resources Advisor Tracie Galbraith Clinical Research Support PHSA Director Clinical & Population Health Anne Junker Director, Communications Jennifer Kohm Communications Specialist Web Developer* Director, Finance Anita Chiu Finance Managers Finance Assistants Contracts Coordinator Research Legal Counsel Board of Directors Chair, Donald Brooks Executive Director Stuart MacLeod Director, Research & Education Services Allison Rintoul Project Associate Manager, Res Education Assistant, Res Ed Initiatives Assistant, Inst Initiatives Assistant, Faculty Initiatives Assistant, Reading Room Manager, REB Manager, Pre/Post Review Admin Coordinator, REB UBC Scientic Director Geo Hammond Senior Research Development Facilitator Dawn MacArthur Research Development Facilitator Proposal Coordinator(s) Grants Assistant(s) Technology Transfer Manager (UILO) Manager, Facilities & Operations Todd Jacques Facilities Coordinator Facilities Assistant Animal Unit Senior Tech Tech(s) Level 3 Lab Asst Level 1 Manager, IM/IT Gurm Dhugga Systems Analyst System Tech Web Developer*
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1 33 0 34 0 M A G N E T I C V A R 9
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ii BRITISH COLUMBIA
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2 EXECUTIVE SUMMARY BRITISH COLUMBI
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4 INTRODUCTION BRITISH COLUMBIA Wit
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6 Health Authority (URL) Key Facili
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8 FIGURE 2. Clinical Trials Units,
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20 TABLE 3. Clinical Trials Support
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22 Much clinical research - particu
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24 FIGURE 3. Source of Funds for Cl
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26 BRITISH COLUMBIA FIGURE 7. Thera
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28 BRITISH COLUMBIA Clinical Invest
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Disease Area Population Information
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32 CV/Cardiology CNS Pulmonary Canc
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34 TABLE 9. Health Economics and He
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40 Network B.C. Investigator’s Ro
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42 Network B.C. Investigator’s Ro
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Pediatrics INSTITUTION EMAIL URL DI
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Pediatrics (cont’d) INSTITUTION E
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248 APPENDICES 7-13 TABLE OF CONTEN
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250 TABLE A3. Patient and Addiction
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252 TABLE A3. Patient and Addiction
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258 APPENDIX 9. Healthcare Research
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Networks In Which B.C.’s Clinical
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312 B.C. Centre for Disease Control
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314 University of Victoria Brenda D
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316 BRITISH COLUMBIA
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