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