Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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88 BRITISH COLUMBIA Gastroenterology The Division of Gastroenterology supports clinical trials at both VGH and St Paul’s Hospitals (no URL). Principal Investigators include the following, whose details can be found in Appendix 6: • Anderson, Frank • Gray, James • Byrne, Michael • Weiss, Alan • Enns, Rob • Yoshida, Eric They conduct clinical trials in colitis, Crohn’s, liver disease (e.g., hepatitis, cancer), GERD and erosive esophagitis, motility, and other areas of gastrointestinal disease. Contact: Byrne, Michael. Tel: 604 875-5640. michael.byrne@vch.ca. Obstetrics and Gynecology Department The Department of Obstetrics and Gynecology (www.obstgyn.ca) supports its faculty that are involved clinical research in many B.C. hospitals, including B.C. Women’s Hospital, Vancouver General Hospital, St. Paul’s Hospital, and Royal Columbian Hospital. They work with the infrastructure provided by hospital and health authority based resources. Investigators include the following whose details can be found in Appendix 6: B.C. Women’s Hospital VGH • Butler, Blair • Brotto, Lori • Cheung, Anthony • Kwon, Janice • Delisle, Marie France • Miller, Dianne • Gagnon, Alain • Sanders, Barry • Lim, Ken • Magee, Laura St Paul’s • Marquette, Gerry • Cundiff, Geoff • Mayer, Chantal • Geoffrion, Roxanna • Money, Deborah • Skoll, Amanda Royal Columbian • von Dadelszen, Peter • Sorokan, Todd Contact: Fernandez, Ariadne. Research Program Manager. afernandez@phsa.ca.
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 89 APPENDIX 2. DESCRIPTION OF B.C.’S CLINICAL TRIALS SUPPORT UNITS Providence Health Care Society Providence Health Care Research Institute (PHCRI) and the Centre for Health Evaluation and Outcome Sciences (CHEOS) The Providence Health Care Research Institute (PHCRI) and the Centre for Health Evaluation and Outcome Sciences (CHEOS) (www.cheos.ubc.ca), the clinical research centre of PHCRI, work together to provide support for investigators conducting clinical research. PHCRI provides the following administrative services through the Office of Research Services [12 employees]: • Research Ethics Board review • Contract Negotiation • Human Resource Management of PHCRI employees • Financial administration. CHEOS is an interdisciplinary research collective of 45+ investigators and houses a Clinical Trials Support Unit (CTSU) to facilitate and assist Providence Health Care clinical investigators with the development and management of clinical trials. Services include: • Study design and methodology • Statistical analysis • Budget planning • Study logistics • Health economic analysis • Data form creation (paper or electronic) • Database development • Data entry/validation • Training including clinical research regulations, investigator’s meetings and study procedures for clinical site personnel • Study document creation including informed consent form templates, standard operating procedures, study manuals, and participant advertising • Regulatory process and documentation • Project management assessment • Study registration • Assistance with knowledge translation The CTSU conducts Phases II through IV clinical trials. Forty-five researchers who conduct clinical trials are affiliated with CHEOS, including those listed in Table A1. Details about those investigators who conduct clinical trials can be found in Appendix 6. CHEOS’ structure is shown in Figure A9. The staff working on CHEOS projects is as follows (total = 66): Clinical Project Managers Study Coordinators Data Managers Information Management* Statisticians Data Entry Health Economists Admin. 5 12 6 16 10 2 7 8 * For example: database administrators, programmers.
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