Compliance and Quality Assurance

The Queen's Research Ethics Compliance Unit provides quality assurance and compliance support services for the Queen's research community to ensure safe, and ethical conduct of human research activities across all disciplines.

Queen’s University has established policies that promote integrity in research, including a commitment to apply the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans as a condition of funding by Canada's three federal research agencies. Members of the Queen’s research community are accountable to these policies when involved in the conduct of research.

The unit’s quality assurance and post approval monitoring program supports the research community by providing oversight services and education to facilitate compliance with applicable policies and regulations, be it institutional, provincial, federal, or international.

Queen's University is a member of the Network of Networks (N2) and provides affiliated researchers with access to [hyperlink] CITI’s online training, as well as access to N2’s complete set of Clinical Research Standard Operating Procedures (SOPs) and clinical research templates. Please explore these and other resources, found below.

For questions or additional information, please reach out to the Ethics Compliance Advisor.

 Resources

Queen’s University is a member institution of the Network of Networks. The Network of Networks (N2) organization recently released the updated English version (Version 10; dated May 31, 2023) of the SOPs for clinical research. Queen’s University Ethics Compliance Unit recommends that all Queen's clinical researchers adopt the use of the N2 SOPs for clinical research. Changes to the formal set of these SOPs at the Institution or site/lab level are not recommended, and may result in the SOPs no longer being compliant with regulations and guidelines.
 
Documented proof of training must accompany any adopted SOPs.
 
The English version of the SOPs were signed off on by Executive Director, Research Strategy, Vice-Principal Research, with May 31, 2023 being used as the effective date.
 
These SOPs may not be shared with individuals external to the institution. The SOPs are available for auditing purposes upon request (e.g. Health Canada, Sponsor or funding agency, REB). These individuals and authorities may review the SOPs, but may not remove them from the site.

 Queen's NETID is required to access the SOPs
Standard Operating Procedures (SOPs)

 Other SOPs Resources

Document Category
Letter of Assurance Rollout Material
N2 V10 SOP Quiz with Justification (May 2023) Rollout Material
N2 V10 SOP Quiz without Justification (May 2023) Rollout Material
N2 V10 SOP Rollout Letter (May 31, 2023) Rollout Material
Table of Contents SOP Table of Contents
Training Log Training Log
Glossary of Terms Glossary

 

Clinical trial registration helps to promote transparency in research, prevent publication bias, and reduce duplication of efforts. Per the TCPS2, all clinical trials must be registered in a free-to-access, public registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE). Trial registration must occur before the first participant visit. This is a compliance requirement for all clinical trials funded by Canada's Tri-agencies (CIHR, SSHRC, NSERC), as well as those funded by the NIH in the United States. For investigator-initiated research, the principal investigator is the party responsible for registration.

Queen's researchers often use clinicaltrials.gov  websites.

Researchers are responsible for ensuring timely information updates to registered trials. For trials registered at clinicaltrials.govUPDATES MUST BE MADE ATLEAST ONCE EVERY 12 MONTHS. Other information, such as the study start and completion dates, must be made within 30 days of the change.

For CIHR-funded clinical trials:
If you have received CIHR GRANT FUNDS FOR CLINICAL TRIAL RESEARCH AFTER JANUARY 1, 2022, you must additionally ensure:

  • All study publications include the registration number/trial ID
  • Publications describing clinical trial results must be open access from the date of publication.
  • Summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome). This is congruent with NIH funding policy, as well as the U.S. Regulations .

For more information, visit CIHR page

Training Matrix

Training Resources Type of Research
Observational Health Research, Retrospective Chart Review, Non-Health Related Research Intervention Health Research (non-regulated) Regulated Clinical Trials
Investigational Drug Natural Health Product Investigational Device
Tri-Council Policy Statement (TCPS2) X X X X X
Good Clinical Practice (ICH GCP)   R X X X
Health Canada, Food & Drug Relations, Part C, Division 5     X X  
N2 Clinical Research SOPs   R X X X
Indigenous Community Research Partnerships R R R R R
If conducting research involving Indigenous peoples, their data, materials, and/or biological samples

X: required training

R: recommended training, as applicable

 

Training and Tools
Course on Research Ethics (CORE) training  
Collaborative Institutional Training Initiative (CITI) training
Indigenous Community Research Partnerships Training Resources 

Updated November 2023

Ethics Compliance Advisor 

silhouette ashley theis

Ashley Theis

Associate Director, Research Compliance and Training

ashley.theis@queensu.ca

355 King St. West