Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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94 BRITISH COLUMBIA FIGURE A9. Centre for Health Evaluation and Outcome Sciences Dr. Yvonne Lefebrve Vice President, Research & Academic Affairs Providence Health Care Research Institute Dr. Aslam Anis Director, CHÉOS Professor, School of Population & Public Health UBC John Orr Director of Operations Joel Singer/Hubert Wong Co-Department Heads, Statistics, Data & Methodology Erin Cherban Manager, Clinical Trial Support Unit Research Administrative Coordinator & Bookkeeper Statisticians, Data Managers Database Developers, IT, Programmers, Data Entry Health Economist Clinical Research Project Managers PHC Ethics Submission Coordinator 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. 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 PHSA Board of Directors Chair, Donald Brooks UBC Executive Director Stuart MacLeod Clinical Research Support Director Clinical & Population Health Anne Junker Scientific Director Geoff Hammond Human Resources Advisor Tracie Galbraith Director, Communications Jennifer Kohm Director, Finance Anita Chiu Director, Research & Education Services Allison Rintoul Senior Research Development Facilitator Dawn MacArthur Manager, Facilities & Operations Todd Jacques Manager, IM/IT Gurm Dhugga Communications Specialist Web Developer* Finance Managers Finance Assistants Contracts Coordinator Research Legal Counsel 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 Research Development Facilitator Proposal Coordinator(s) Grants Assistant(s) Technology Transfer Manager (UILO) Facilities Coordinator Facilities Assistant Animal Unit Senior Tech Tech(s) Level 3 Lab Asst Level 1 Systems Analyst System Tech Web Developer*
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