Research Ready Mentor Spotlight – November 2020
Each month, a Research Ready mentor from the Community of Practice hosts an online workshop to share best practices and highlight exceptional processes. Be sure to sign up for the November workshop with Ellen Morrison and Stephanie Badour. And don’t forget to join the Research Ready Community of Practice for ongoing discussion after the event.
Remote monitoring: Tips & Tricks from both sides of the screen
COVID-19 has changed the way we monitor trials, maybe forever. The C17 has been utilizing this model for many years in the oversight and quality assurance of trials. In this interactive session, Ellen and Stephanie will share some best practices for the preparation and execution of a remote monitoring visit. Whether your site has full access EMR, uses redacted documents or video conference platforms, there are ways to improve the efficiency of this monitoring approach that can be easily adopted. Ellen and Stephanie have been working together in the peer-to-peer monitoring program and more recently using remote monitoring, and are going to share their best tips and tricks with you in this session.
Mentor Spotlight: Ellen Morrison and Stephanie Badour
Ellen Morrison is the Research Manager for the C17 Council with eight years experience in the regulatory management of clinical trials for pediatric oncology. Ellen is responsible for overseeing the Canadian regulatory management of multi-centre academic pediatric oncology/hematology clinical trials for international sponsors. This includes oversight of clinical trial application submissions and communication with Health Canada, ensuring regulatory compliance of Canadian sites and implementation of monitoring programs which comply with the Health Canada regulations. In response to the COVID-19 pandemic, she has developed and implemented multiple remote monitoring programs to allow Phase I/II/III clinical trials to remain open and in compliance with the regulations.
Stephanie Badour has been working in pediatric hematology/oncology clinical research for 13 years, and has worked across the spectrum of disease types and phases of clinical trials. She began her career at BC Children’s Hospital and 3 years ago moved across the country to become the Clinical Research Unit Manager at Montreal Children’s Hospital. Stephanie also monitors other sites for the CCTG and the C17 Council multiple times per year. In addition, she conducts internal monitoring at least 2 times per year since C17 began the peer-to-peer monitoring program. She is excited to provide insight from the perspective of both a monitor and a site CRA.
Online Workshop Details:
Date: November 3, 2020
Time: 1pm to 2pm
Registration: click here
Can’t make it to the workshop? A recording will be posted on the Research Ready page shortly after.