The COVID-19 crisis has created a need to rapidly expand clinical trial capacity in all regions of BC. The intent of this program is to condense the training time for trial personnel supporting site research teams while ensuring quality are absolutely essential to these efforts.”
– Cindy Trytten, Director of Research and Capacity Building, Island Health
Clinical Trials BC launched its new COVID-19 Rapid Response Training Program in April 2020. This program was developed for new researchers, new research team members and in particular, new supporting personnel that will be involved in COVID-19 clinical trials.
Jean Smart, Regulatory Affairs and Quality Officer has organized training modules and supporting materials on a Clinical Trials BC ECoP (Electronic Community of Practice) established for COVID-19 Rapid Training.
The modules include:
- Regulatory Introduction (Canadian regulatory environment, Historical Documents);
- Core ICH (E6 -Good Clinical Practice, E8- General Considerations in Clinical Trials, E17- Multi-Regional Clinical Trials);
- Research Teams (Roles and Responsibilities, Training and Qualifications);
- Records (Essential Documents, Good Documentation Practices); and
- Special Topics (safety, Investigational Product, Data).
These modules include access to supporting reference documents, condensed notes, recorded sessions, slides and self-quizzes). We will continue to add to the programme over the coming weeks and welcome any suggestions.
“[Research and Quality Managers] can preview and select the modules and units that fit the training requirements of the new site/study personnel. Appropriate training opportunities and the best head start will be provided, while we quickly prepare for COVID-19 trials.”
– Coleen Adderley, Manager of Clinical Research, Interior Health