Clinical Research Quality Initiatives
The Clinical Research Quality website is a central space for information about clinical research quality initiatives being undertaken at UHN.
The first of these initiatives was the establishment of the Clinical Studies Quality Committee (CSQC) in 2008. This committee reports to the Quality Committee of the Board and is chaired by EVP Catherine Zahn and VP Research Christopher J Paige.
Terms of Reference
Purpose
Provide UHN-wide leadership for patient safety and best practice in clinical research.
Principles
- Ensuring safe patient care
- Sustaining both the clinical and academic mission of UHN
- Maintaining investigator responsibility for research best practice
- Confirming organizational accountability for clinical research
Responsibilities
- Define clinical research best practice for UHN through review of other institutions, literature and stakeholder consultation
- Develop best practice policies for clinical research and oversee implementation
- Develop risk management initiatives for the clinical research environment that include monitoring, reporting and improvement components
- Develop and oversee implementation of training and credentialing policies and procedures for all staff involved in clinical research
- Oversee internal reviews/audits of clinical research studies
- Examine the conduct of external audits by sponsors and other agencies through review of their processes, reports and recommendations
- Develop and oversee communication strategies for risk identification and reporting, in partnership with UHN Public Affairs
- Appoint sub-committees, working groups and other ad hoc bodies as necessary
NEW AND ONGOING INITIATIVES
Several projects have been initiated since 2008 by the Clinical Research Support Services Planning and Implementation team, chaired by EDRO Lisa Alcia.
Mandatory Principles of Clinical Training and Certification
All clinical research personnel are required to take this course by December 2009 (as per policy #40.20.004 Clinical Research Training) and to maintain their certification thereafter.
Course Objectives
- Translating regulatory requirements and principles of GCP into action
- Strengthening teamwork and communication
- Examining best practices in clinical research practice
- Developing corrective and preventative action plans
- Understanding roles and responsibilities of Qualified Investigator and Clinical Research Coordinator
Course Content
- Ethical principles of clinical research
- Roles and responsibilities
- Managing and meeting regulatory requirements
- Translating good clinical practice principles into action
- Next steps after an audit
- Principles of project management
- Documentation
- Best Practices
Training is held from 8:30AM to 4:30 in a one-day interactive workshop on-site at UHN.
If you have any questions, please contact Gina Vaccaro, Administrative Assistant, Clinical Research Practice, gvaccaro@uhnres.utoronto.ca.
New Internal Audit Program
The Research Quality Improvement Internal Audit Program was implemented in Spring 2008 to provide a systematic and independent quality review and reporting of research activities at the University Health Network (UHN) (view policy #40.80.001 Research Quality Improvement Internal Audit Program). The program is lead by Katie Roposa, Manager of Research Quality Improvement. Internal audits will focus on:
- Research subject/ staff safety
- Compliance
- Good/ leading practices
- Data integrity
New Department of Clinical Research Practice
The department of Clinical Research Practice was launched in May 2009. This department, lead by Melody Boyd will work in collaboration with investigators to prepare for external audits and to implement corrective action plans following internal audits. This team will also establish standards in professional practice, tools, training and programs that enhance clinical research quality at UHN.
Professional Practice
Clinical Research Personnel need to be classified and trained appropriately for the tasks being performed. A draft policy is in the approval stages that will require investigators to review roles and responsibilities of team members and classify and train appropriately. A new job classification matrix for clinical research is being designed and will be implemented by June 2009.
Quick Reference Guide for PI’s
A reference guide for Investigators on the following aspects of clinical research is under development to address:
- Audit
- Delegation
- Contracts
- REB
- Mandatory Training
- PI as sponsor
New Policies
- Research Quality Improvement Internal Audit Program
- Clinical Research Training
Internal Resources
Training
Useful links
