Clinical Trials BC News | Phase two of quality management system for clinical regulations launched in BC
A revision of the International Good Clinical Practice document, ICH E6R2, will be implemented in Canada effective April 1st, 2019. This document, replacing a previous version, is far more descriptive of the requirements for quality and risk management components at the institution, program and site levels.
Coinciding with this change, Clinical Trials BC identified the challenges associated with individual institutions implementing quality systems and launched a new phase of an accessible Quality Management System (QMS) Program for BC researchers and institutes. The program is available to academic-health-science-associated institutions, programs and centres, and specialized sites.
Clinical Trials BC’s provincial approach provides research organizations, programs or centres with nine pre-developed quality management systems (policies, Standard Operating Procedures, forms, trackers) and supporting tools (manuals, development plans), designed to be adaptable to the institution.
Click the button below to learn more about Clinical Trials BC's new provincial QMS program.
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