Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
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70<br />
BRITISH COLUMBIA<br />
PROVIDENCE HEALTH CARE SOCIETY 4<br />
St. Paul’s Hospital<br />
St. Paul’s Hospital is an acute care, teaching, <strong>and</strong> research hospital located in downtown Vancouver<br />
(www.providencehealthcare.org/info_stpauls_main.html). It is home to many world-class medical <strong>and</strong><br />
surgical programs, including cardiac services, HIV/AIDS <strong>and</strong> kidney care. St. Paul’s serves both the local<br />
community <strong>and</strong> patients from across B.C. <strong>and</strong> the Yukon. It houses three CTUs that are described below.<br />
Information on its health research centres can be found in Appendix 9.<br />
AIDS Research Program<br />
The AIDS Research Program (www.cfenet.ubc.ca/content.phpid=18) is affiliated with the B.C. Centre<br />
for Excellence in HIV/AIDS. It conducts clinical trials <strong>and</strong> observational studies in persons with Human<br />
Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) – HIV coinfection, <strong>and</strong> fungal infection.<br />
The Unit conducts Phases II, III, <strong>and</strong> IV clinical trials. They accrue 100 – 200 patients per year.<br />
The Centre has five Principal Investigators as listed below <strong>and</strong> seven Associate Investigators. Their details<br />
can be found in Appendix 6.<br />
• Barrios, Rol<strong>and</strong>o • Phillips, Peter<br />
• Guillemi, Silvia • Tyndall, Mark<br />
• Montaner, Julio<br />
Program staffing is as follows:<br />
Study Nurses/ Coordinators<br />
1<br />
Research (<strong>Clinical</strong> Pharmacy Staff Laboratory Staff Administration<br />
<strong>Trials</strong>) Asst. 3<br />
3 * 1 0 0 2**<br />
* The study (clinical trials) coordinators also perform data entry activities (in source documents <strong>and</strong> CRFs) as part of their role.<br />
** 1 Admin. Coordinator (operational manager); 1 Accountant.<br />
The process for getting trials approved in this unit is as detailed below:<br />
a) Submission of the Study Protocol <strong>and</strong> other required documents by the <strong>Clinical</strong> <strong>Trials</strong> Assistant to the<br />
Providence Health Research Ethics Board for review <strong>and</strong> approval.<br />
b) <strong>Clinical</strong> <strong>Trials</strong> Assistant requests the different departments (e.g., Laboratory, Pharmacy, Radiology, etc.)<br />
involved in this study for approval. Approval letters from the different department are then submitted<br />
to the Offices of Research Services.<br />
c) Contract personnel at the Offices of Research Services ensures the contract has been approved <strong>and</strong><br />
signed.<br />
d) The Offices of Research Services then releases the Certificate of Final Approval.<br />
Quality control/ assurance procedures are based on St<strong>and</strong>ard Operating Procedures (SOPs). The SOPs<br />
cover all study-related functions <strong>and</strong> responsibilities <strong>and</strong> reflect ICH <strong>and</strong> federal regulations . SOPs are<br />
updated as necessary. Staff members are provided training on a regular basis to the site-specific SOPs<br />
<strong>and</strong> GCP protocols. All projects are approved by the REB prior to initiation.<br />
Contact:<br />
Chau, William. Tel: 604-806-8064. wchau@cfenet.ubc.ca.<br />
4<br />
Providence is an independent legal entity aligned with VCH for operational purposes.
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