The Office of Surgical Research Services (OSRS) proudly hosted their sixth Mini-Workshop on January 23, 2018 at the Juravinski Cancer Centre.
The topic of the Mini-Workshop was “How to Prepare for a Health Canada and Sponsor Audit”. Dr. Farrokhyar, the Director of the OSRS, and the OSRS team wanted to create an event that would help inform and prepare research personnel for clinical trial investigations and audits. Such a goal could only be achieved by inviting guest speakers who have extensive knowledge and experience on the topic. One of our honored speakers, Ms. Shila Rastegar (Compliance Specialist from Health Canada) began the event by providing detailed information on Health Canada’s clinical trial compliance program. Ms. Rastegar presented the roles and responsibilities of Health Canada, touched on regulatory framework, and concluded with common compliance issues and facts.
Mr. Adam Weerdenburg (Research Quality Assurance Officer from The Research Institute of St. Joe’s Hamilton), presented an expert overview of quality assurance in clinical research. Mr. Weerdenburg highlighted the systems and standards of quality and described the internal monitoring services offered by the Research Institute. Ms. Janice Sancan (Research Ethics Officer) and Ms. Deborah Mazzetti (HiREB Manager) presented HiREB’s role in clinical trial audits, detailing the resources they provide and the importance of complying with Standard Operating Procedures. Finally, Ms. Brenda Kowaleski (Clinical Trial Manager at Juravinski Cancer Centre) and Ms. Tessa Elliot (Research Assistant in the McMaster Pediatric Surgery group) presented their experiences with Health Canada investigations and sponsor audits. Speaking from first-hand experience, they each gave valuable insight and recommendations to the attendees in preparing for an investigation or audit. Concluding the event, a lively panel discussion allowed the attendees to have their questions answered by the speakers.
The workshop was well-received by over 50 attendees from varying departments. The evaluation of the workshop was significantly positive; 100% of surveyed participants found the workshop to be informative and supported the continuation of the OSRS mini-workshop series. One respondent stated that the “panel members were engaging and presented material well”, while another commented that “the workshop was very helpful and addressed a lot of concerns involved with undergoing an audit”.
Dr. Farrokhyar and the rest of the OSRS team would like to give a special thank you to Ms. Laura Garrick (Research Contracts and Events Coordinator from the Research Institute of St. Joe’s Hamilton), who worked hard to assist with organizing and supporting the workshop. A thank you also goes out to the Research Institute of St. Joe’s, Hamilton, for their collaboration and their support of this event.
Dr. Farrokhyar and the OSRS team strive to support high quality research across the Department of Surgery. The OSRS has made it a priority to host Mini-Workshops addressing different concepts of research methodology and covering the most desired topics for research personnel. Given the success of these events, the OSRS is pleased to continue to host Mini-Workshops in the future!