Hamilton investigators are very good at doing what they do best….Research!!
The impact of their research informs policy, health services and best practices so that our patients and community receive the best care possible.
Research Administration Offices strive to share information and support researchers and their teams to limit the level of involvement as well as the time they spend on administrative processes.
One of many areas Research Administration focuses on is sharing best practices and resources to ensure efficient and high-quality research, integrity of clinical practices and accountability-all are excersided in the conduct of clinical research activities. As enablers of such activities, Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, and McMaster University – Faculty of Health Sciences have jointly adopted a set of Standard Operating Procedures (SOPs) for clinical research and Good Clinical Practice (GCP) education and training resources through respective membership affiliations with N2 Canada as a minimum standard that is compliant with Canadian guidelines and regulations (Health Canada and Drug regulations, ICH Good Clinical Practice guidelines, TriCouncil Policy Statement: Ethical Conduct for Research Involving Humans guidelines and US Food and Drug Administration regulations) and that are expected by regulatory authorities.
An overview provided below highlights the importance to better understand the purpose of clinical research SOPs and GCP education and training:
Clinical Research SOPs are critical to quality performance and ethical conduct of clinical trials. The SOPs indicate the level of professionalism by providing documented procedural guides and help ensure consistency, compliance, accountability and efficiency of the investigator and investigator’s team in conducting clinical trials that are expected by regulatory authorities when conducting audits.
GCP Training is a regulatory requirement (as defined by the TriCouncil Policy Statement), as well as an institutional requirement (for submission of HiREB applications) for conducting clinical research activities that ensures compliance with best practices. In addition, more and more regulatory and sponsor monitoring visits are requesting evidence of training for all research team members, not just the investigator.
Complimentary access to a set of SOPs and GCP education and training are readily available to researchers and their team members through each institution’s Research Administration Office:
HHS Research Administration Donna Catherwood (email@example.com)
McMaster Health Research Services Wendy Hollinshead (firstname.lastname@example.org)
SJHH Research Administration Adam Weerdenburg (email@example.com)