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
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
A new policy regarding the Responsible Conduct of Research outlines the following important information:
- Classification of research misconduct
- Responsibilities of the complainant, respondent and Vice President, Research
- Detailed complaints process
All concerns raised regarding failures to comply with regulations, potential misconduct or allegations of misconduct should be made in good faith. Each case will be investigated in an impartial, timely, fair and transparent manner while maintaining the greatest level of confidentiality.
Training sessions will be available in 2012 on the Research Intranet Event Calendar to help you and your team become familiar with this policy.
It is important to know your responsibilities as research personnel to help ensure the highest standard of public trust and integrity.
Conflict of Interest of Research Personnel Policy
In conjunction with the Responsible Conduct of Research Policy, the Conflict of Interest of Research Personnel Policy outlines UHN's stance on the obligation that research personnel do not conduct research with an unmanaged conflict of interest. All research personnel must disclose, in writing, all actual, apparent, perceived and potential conflict of interest situations.
Additional details regarding this policy include the process for disclosure, confidentiality, and responsibilities of the Principal Investigator or Manager.
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.
New Infrastructure for Clinical Research
High quality research utilizes formally documented processes and practices that ensure patient rights and safety, accurate data capture and reporting, and compliance with UHN policies, good clinical practice principles and regulatory requirements.
Department of Quality Integration
The Quality Integration (QI) program proactively identifies and helps to manage risks in key areas of staff and patient safety. The QI program at UHN includes the following: Internal Quality Auditing, Emergency Preparedness, Policy and Procedure Development, Health and Safety.
Department of Clinical Research Practice
The Department of Clinical Research Practice (CRP) aims to help maintain the highest quality of conduct in clinical research by providing education programs and standardized practices for all of UHN's clinical research programs.
Through the use of training programs and education sessions, CRP helps to foster an environment where clinical research is performed ethically, reliably, and to the highest standards according to regulatory requirements. CRP's services include, but are not limited to, Good Clinical Research Practices, Clinical Study Toolkits, Venipuncture Training and Lab Space. UHN staff can visit the department's website for new and upcoming workshops.
