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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

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
Clinical Studies Quality Committee Members
Co-Chairs: Charles Chan, Christopher J. Paige
Walter Kucharczyk Lisa Alcia
Neil Fleshner Patrik Rogalla
John Floras Bella Martin
Carole Garmaise Deepali Kumar
John Granton Emily Musing
Flavio Habal Paul Oh
Amit Oza Katie Roposa
Emily Musing David Urbach
Kathryn Nichol

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.

Clinical Research Support Services Planning and Implementation Team Members
Lisa Alcia Rosalyn Reid
Katie Roposa Anita Sengar
Paul MacPherson Michael Voth
Tom Goldthorpe Alexander Karabanow
Siavash Ebbadi Ajay Pillai
Carrie-Lynn Keiski Katherine Patterson

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.

Protocol Compliance

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

TrialScribe 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.


   
 
 
 
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