Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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APPENDIX 3.
QUALITY CONTROL/ QUALITY ASSURANCE AT B.C.’S
CLINICAL TRIALS UNITS, CENTRES, AND STUDY SITES
BRITISH COLUMBIA
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