Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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BRITISH COLUMBIA
Much clinical research - particularly cancer-related - is multi-centred and collaborative, thus subject to
ethical review by each of the involved institutions. To minimize the requirement for multiple reviews
of research presented to the UBC, Providence, and BCCA REBs, these institutions have agreed that the
initial review may be conducted by any of their four REBs and that the other three will, in most cases,
honour the outcome of the that review. Further, the REB that reviews and approves a protocol is responsible
for subsequent supervision.
The MSFHR-led “B.C. Ethics Harmonization Initiative” 14 is developing a harmonized provincial approach
to ethics approval, including:
• Creating common forms (e.g. application forms, informed consent)
• Developing a shared/ common IT platform and tools accessible to researchers and institutions at
which human subject research is undertaken in B.C.
• Exploring how ethics review for multi-centre trials can be more efficient, consistent, and timely,
possibly with some degree of inter-institutional reciprocity
• Developing common educational and training resources to be shared by REBs.
Training Facilities
All B.C.’s CTUs, centres, and study sites ensure that their investigators and staff are trained in clinical trial
procedures, SOPs, and appropriate (i.e., Health Canada, FDA, ICH) GCP regulations and guidelines, as
indicated in Appendix 1. Such training is usually in-house or via on-line GCP courses. In addition, there
are at least nine training programs in the Province that specifically focus on clinical trials. These are listed
in Table 4 and detailed in Appendix 5.
TABLE 4. Clinical Trials Training Facilities
Facility (URL)
Description
ASKA Research (http://askaresearch.
trainingcampus.net)
CHEOS Clinical Research Education
Series (no specific URL within www.cheos.
ubc.ca)
Clinical Research Professional Development
(CRPD) Education Program (www.
cfri-training.ca/training/ClinicalResearchCoordinators.asp)
CFRI Monthly Education Forum (www.
cfri-training.ca)
Global Client Partners Consulting Inc.
(www.gcpconsultants.com)
Health Information Science, UVic (http://
hinf.uvic.ca/)
Offers on-line courses and guides on ICH/GCP regulations, roles and requirements;
GCP-compliant clinical trials for investigators, coordinators, monitors, and sponsors;
informed consent; and project management.
Offers clinical research education to investigators and clinical research coordinators.
Supports professional development of clinical research coordinators and research
staff involved in all aspects of clinical research.
Specific to Clinical Research Coordinators, an education forum focused on clinical
research.
Offers training in ICH: Good Clinical Practice Guidelines; Code of Federal Regulations;
Investigator and Coordinator Meetings; Standard Operating Procedures; Essential
Documents; and the conduct of investigator-initiated studies.
Offers a range of courses in healthcare management, epidemiology, and medical
methodology; with some aspects of courses and training relevant to clinical trials
management and clinical trials operations.