Good Clinical Practice (GCP) Guidelines requires sponsors of clinical research to implement a quality assurance policy in order to be compliant with the regulations, yet the Guidelines do not provide any advice on how this is to be done. Institutions are left to their own devices to figure out what a quality assurance office or unit would look like.
Quality assurance describes a program for the systematic monitoring and evaluations of the various aspects of a project, service, or facility to ensure that standards of quality are being met. There are many ways to implement this type of program. When the University of Calgary decided to implement a Quality Assurance program in 2016-17 we had to determine our pathway. Fortunately, there were models in place at other Canadian institutions and we were able to consult with colleagues to determine what methods would work best for our institution. In this presentation, we would like to continue this tradition by offering our own experience for the benefit of others who may be now embarking on their own journey.
Join the University of Calgary's Linda Longpre, Quality Assurance and Regulatory Compliance Specialist to learn:
What does developing a Quality Assurance program for clinical trials look like?
How did we implement it at the University of Calgary?
What were our challenges and successes?
These are some of the questions we had to answer before taking the plunge into quality assurance, and we continue to learn as we implement. It is our hope that this presentation will help you, as you develop your own Quality Assurance Program.