Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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BRITISH COLUMBIA
Quality control/ assurance procedures are based on Health Canada and FDA regulations. The Unit recommends
and makes available the N2 SOPs covering GCP, along with N2 GCP Training modules. SOPs
cover the Data Management and IT platform. All projects are approved by the REB prior to initiation.
CFRI is a participant in the Clinical Research Professional Development (CPRD) team which has a curriculum
coordinated between the Lower Mainland academic health centres, directed for research
coordinators (see Appendix 5).
Contact: Junker, Anne. Director, Clinical & Population Health Studies, CFRI. Tel: 604-875-3591. ajunker@
cw.bc.ca.
Laboratory-Clinical Studies Unit
Based at the B.C. Centre for Disease Control, the Laboratory-Clinical Studies Unit (www.phsa.ca/bccdcpublichealthlab)
is associated with the B.C. Public Health Microbiology & Reference Laboratory (the
primary public health and reference diagnostic testing facility for the province). It provides laboratory
support for clinical trials on new molecular microbiology laboratory tests and test procedures, particularly
for HPV, HIV, and Hepatitis. Studies cover screening, diagnosis, treatment, observation, and intervention.
For treatment studies, the Unit provides support to Phases II, III, and IV clinical trials. Annual
patient accrual ranges between 200 -11,000 depending on the study.
The Unit has two Principal Investigators and three clinical trials collaborators listed below. Their details
can be found in Appendix 6.
Principal Investigators
Collaborators
• Krajden, Mel
• Coldman, Andy
• Petric, Martin
• Ogilvie, Gina
• Rekart, Michael
Unit staffing is as follows (Total = 5):
Study Nurses
Data Managers/
Coordinators
Pharmacy Staff Laboratory Staff Administration/ Support
Staff*
0 1 Not applicable 4 1 (business consultant)
For trials to be approved by the unit, the investigator must complete a project approval form and attach
the clinical trial protocol, ethics approval documents, and funding approval documents for review.
Upon review, the CTU will provide a laboratory cost estimate which all parties must sign-off before final
approval.
Since many of the tests conducted are new procedures, QC/QA procedures are newly developed for
each one as follows:
• Firstly, receive training from Vendor/Manufacturer of the new product/procedure
• Secondly, the CTU performs an in-house validation and comparison if applicable
• Thirdly, SOPs and QC procedures are created by the CTU following the College of American Pathologists
(CAP) guidelines
• Finally, other staff at the BCCDC are trained in the test, SOPs, and QC procedures.