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 VP Medical Affairs Charles Chan and VP Research Christopher J. Paige.
Terms of Reference
Provide UHN-wide leadership for patient safety and best practice in clinical research
- 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
- 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.
Below are some of our new policies available now in the Research Policy Manual.
Responsible Conduct of Research Policy
The revised Responsible Conduct of Research Policy covers the classifications of research misconduct, such as falsification, fabrication, plagiarism and non-compliance with accepted regulations; expected responsibilities of all parties involved; and the step-by-step inquiry and investigation process.
Revisions to the policy include a clarification of, and additions to, examples of research misconduct; additional responsibilities of the Vice President, Research; updates to the response to concerns regarding research integrity and the complaints process; and a statement regarding UHN’s commitment to privacy and confidentiality.
UHN is dedicated to the promotion of research integrity. Each member of the research community has a responsibility to foster intellectual honesty and trust and to be vigilant regarding the conduct of research.
The new Protocol Compliance Policy outlines the minimum requirements of a research study that need to be included in the written protocol. This policy also includes information on what constitutes a protocol amendment and deviation, in addition to defined roles of a sponsor and sponsor-investigator. Receiving protocol approval by the Research Ethics Board (REB) and the institution, and adhering to this policy will ensure that research best practices and data integrity are maintained for your study.
News and Events
TrialScribe - Clinical Research Newsletter
is a bi-monthly online newsletter devoted to the latest clinical research news and events at UHN. Each issue of TrialScribe
will serve as a 'one-stop shop' for the latest policy and regulation updates, educational toolkits, news articles, a feature spotlight on a clinical research program, and case studies addressing research best practices with tips on how to improve your research environment.
To access current and previous issues of TrialScribe, visit the archive here.