Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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106 BRITISH COLUMBIA APPENDIX 3. QUALITY CONTROL/ QUALITY ASSURANCE AT B.C.’S CLINICAL TRIALS UNITS, CENTRES, AND STUDY SITES Eighteen facilities were visited and interviewed for this report. SOPs and other documentation involved in the assurance of quality and maintenance of consistency were reviewed. All facilities had documentation pertaining to: • Informed consent • Compliance with Health Canada, FDA, and ICH GCP regulations and guidelines. Furthermore, since all sites obtain written approval to conduct a clinical trial from a duly constituted Research Ethics Board prior to commencement, all units: • Maintain confidentiality (in addition, confidentiality is part of the informed consent, and all units follow Canada’s stringent privacy laws; furthermore, for completeness, 2/3 had additional separate written documentation regarding confidentiality) • Report adverse events to sponsors and regulators (and more than 2/3 had additional separate written documentation regarding this) • Adhere to the REB requirements for protocol amendments, ongoing review, and clinical trial status reports. Moreover, at least half the units had written documentation (usually SOPs) pertaining to: • The REB process • Collection of blood • Process for accepting trials into the unit • Collection of other biological samples • Study initiation • Handling of other biological samples • Data collection • SOP updating requirements • Data management • Training requirements • Data reporting to sponsor • Activity Responsibilities • Management of adverse events Other written documentation, again mainly in the form of SOPs, included: • Procedures for contracting services such as statistics, budgeting, contracts support • Handling of blood • Data analysis • Investigational Drug Handling • Study Closure • Recruiting • Archiving • Communication • QA procedures
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 107 APPENDIX 4. B.C. RESEARCH ETHICS BOARDS Information from The Ethics Review Process in British Columbia: An Environmental Scan. Michael Smith Foundation for Health Research. October 2007. www.msfhr.org/resources/public/Reports/BC_Scan.pdf. Accessed October 21, 2009. Data valid to 2007. REB = Research Ethics Board. REBs Associated with Institution/ Organization Type of Institution/ Organization Year REB Established B.C. Cancer Agency Health Services Academic 2003 B.C. Institute of Technology Academic 1999 Camosun College Academic 2006 Canadian Blood Services (B.C.) Health Services (national NGO) 2001 Community-Based REB Community 1999 Fraser Health Health Services 2004 Interior Health Health Services 2005 Inter Tribal Health Authority Aboriginal (in progress 2007) Kwantlen University College Academic 2002 Malaspina University-College Academic 2002 Northern Health Health Services 2007 Providence Health Care Health Services 1996 Royal Roads University Academic 2000 Simon Fraser University Academic 1996 Thompson Rivers University Academic 2001 Trinity Western University Academic 1995 University College of the Fraser Valley Academic 2002 University of British Columbia (also reviews Vancouver Coastal Health and Provincial Health Services Academic Clinical: 1983 Behavioural: 1976 Authority except adult oncology) University of Northern B.C. Academic-Medical Faculty 1994 University of Victoria Academic-Medical Faculty 1999 The Vancouver Foundation Community 2004 Vancouver Island Health Authority: Clinical* Health Services 1987 Vancouver Island Health Authority :Health** Health Services 2006
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