Provincial Training Recommendations
2018 Update
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Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). (ICH GCP 2.8)
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In order to promote high-quality research in Alberta, the ACRC Executive Committee has endorsed new provincial training recommendations. These recommendations reflect Alberta's changing clinical health research landscape.
Highlights:
- A GCP Refresher course has been added and both GCP Basic and Refresher have been updated to reflect E6(R2) content.
- NIH Protecting Human Participants course has been discontinued as of September 26, 2018.
Check with your local institution for organization-specific and mandatory training.
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Building Inquiry and Research into Connect Care
Inquiry and research groups use systematic approaches to answer questions about routine clinical care. In the Connect Care Clinical Information System, there are workflows and tools to support inquiry and research involving patients and their health information. To learn how inquiry and research functionalities will be integrated into Connect Care operations, see the Connect Care Inquiry and Research Update.
The Connect Care Research Team will also be having demos to showcase the research workflows that will exist in the new Clinical Information System, and there will be opportunities to ask questions. Demos will be offered on December 18th (12:15-1:15 PM) and Jan 21st (12-1 PM). To find a viewing venue near you, contact your organization.
Feedback and questions can be sent to acrc@albertainnovates.ca. This will be aggregated and forwarded to the Connect Care Research Team. Inquiries relating to the technical aspects of the design and build can go directly to cc.research@ahs.ca.
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- Standard Operating Procedure (SOP): Version 8 anticipated for release in April 2019.
- N2 CAREB/ACCER REB SOP Committee: Version 3 to be released in 2019.
- Clinical Research Coordinator Course - Canadian Version: Expected release: early 2019.
- The Quality Committee is working to complete three new tools: 1. Quality Management System policy and procedure; 2. Study Risk Assessment Tool (both study and institutional level), and; 3. Risk-Based Monitoring Plan.
Contact your N2 representative for more information or email n2@n2canada.ca.
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This month's hot topic glossary term - Clinical (Health) Research
Clinical (health) research has the goal of improving the diagnosis, prevention and treatment (including rehabilitation and palliation) of disease and injury, and improving and evaluating the health and quality of life of individuals. Clinical research is conducted on, or for the treatment of human subjects. Clinical research includes living human subjects, human tissues, human remains, cadavers, biological fluids, embryos, fetuses and patient information. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. This includes clinical trials on patients, epidemiological and behavioral studies, outcomes research, health services research and population health studies, typically falling under the CIHR rubric of pillars 2, 3 & 4.
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Happy Holidays from the ACRC!
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Cartoon courtesy of: Asijit Sen
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