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Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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76<br />

The facility has 13 investigators as listed below. Their details can be found in Appendix 6.<br />

• Fung, Anthony • Saw, Jackie<br />

• Gin, Ken • Ramanathan, Krishnan<br />

• Hamburger, Jaap • Ricci, Donald<br />

• Isserow, Saul • Virani, Sean<br />

• Jue, John • Wong, Graham<br />

• Lee, P.K. • Wood, David<br />

• Nair, Parvathy<br />

Staffing of the unit is as follows:<br />

Study Nurses/<br />

Coordinators 1<br />

Research Assistants<br />

3<br />

Data Managers/<br />

Coordinators<br />

BRITISH COLUMBIA<br />

Pharmacy Staff Laboratory Staff Administration<br />

(Manager)<br />

7* 2** 0 * 0 0 1 (parttime)***<br />

* All the study nurses/ coordinators (called research coordinators) also h<strong>and</strong>le data. In addition, 1 designs project databases <strong>and</strong><br />

provides statistical <strong>and</strong> IT support<br />

** 1 h<strong>and</strong>les regulatory documents <strong>and</strong> finances; 1 h<strong>and</strong>les specimens <strong>and</strong> provides other clinical support functions.<br />

*** The manager is one of the research coordinators.<br />

The unit uses Vancouver General Hospital pharmacy in its conduct of in-patient clinical trials when<br />

applicable. <strong>Clinical</strong> laboratory tests use the VGH Hospital Laboratory <strong>and</strong>/or are shipped to central laboratories<br />

provided by the trial. Hospital research-designated staff in both pharmacy <strong>and</strong> laboratory have<br />

been essential.<br />

Quality control procedures are based on:<br />

• St<strong>and</strong>ard Operating Procedures for ‘Consenting’ & ‘Adverse Events’<br />

• Following <strong>and</strong> maintaining the Good <strong>Clinical</strong> Practice (GCP), ICH regulations <strong>and</strong> guidelines of<br />

Health Canada <strong>and</strong> the FDA<br />

• Regularly attended education, study meetings, <strong>and</strong> on-line training of GCP provided by the local<br />

clinical Research Ethics Board <strong>and</strong> other programs. All staff have been certified in NIH Human<br />

Protection.<br />

All projects are approved by the REB prior to initiation.<br />

Contact:<br />

Fox, Rebecca. Manager. Tel: 604-875-4065. r.fox@telus.net.<br />

Centre for Menstrual Cycle <strong>and</strong> Ovulation Research<br />

Part of the Vancouver Coastal Health Research Institute, the Centre for Menstrual Cycle <strong>and</strong> Ovulation<br />

Research (www.cemcor.ubc.ca) is the only centre in North America that focuses on ovulation <strong>and</strong> the<br />

causes for <strong>and</strong> consequences of ovulation disturbances. The Centre Director is Jerilynn C. Prior, whose<br />

details can be found in Appendix 6.<br />

The Centre’s clinical trials are investigator-initiated <strong>and</strong> are completely independent of funding sources.<br />

Contact:<br />

Tel: 604–875-5927. cemcor@interchange.ubc.ca.

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