The Vice-Principal Research Portfolio is available to guide you through the ethical and compliant conduct of human participant research throughout the life cycle of your research project, from concept through to study closeout and publication.
We offer expert guidance and consultations for all types of studies that involve human participants, including anonymous surveys, interventional drug, medical devices, and natural health product clinical trials.
Our team also provides oversight of human participant research: we handle reports of alleged non-compliance and work closely with Research Ethics and the research teams at affiliated hospitals.
While the scope of our Research Compliance and Training support for researchers is currently under development, we are pleased to provide information on training requirements and resources such as Standard Operating Procedures (SOPs), tools and templates for research use.
Compliance updates
Date Published: Mar 03, 2026
New Health Canada Good Clinical Practice training requirements
Implementation of the International Council of Harmonization new Guideline for Good Clinical Practice - ICH E6(R3).
Compliance training
| Training | Applicable to | Time commitment |
|---|---|---|
| All researchers and research team members conducting research involving human participants, including their data and/or biological materials | 2.5 - 4 hours | |
| * | All researchers and research team members involved in clinical trials. Repeat every three years or earlier if required | 3 - 4 hours |
| All researchers and research team members involved in clinical trials | 15 minutes | |
| * | All researchers and research team members involved in Health Canada regulated drug clinical trials | 3 - 4 hours |
| Self-study training for all researchers and research team members involved in Health Canada regulated natural health product clinical trials. Training must be documented | 3 - 4 hours | |
| Self-study training for all researchers and research team members involved in Health Canada regulated medical device clinical trials. Training must be documented | 3 - 4 hours | |
| ** | All researchers and research team members involved in Health Canada regulated medical device clinical trials, if above self-study training not completed | 1 - 2 hours |
* These courses are provided by the and made available to the Queen's community through the . To access training courses offered through Queen 国产传媒 鈥檚, please register for a CITI account, using an institutional email address (queensu.ca) and selecting 鈥湽 (N2)鈥 as the organization affiliation.
** This course is provided to the Queen's community by N2. To access, create a , then use the link on the table. If prompted, sign in after clicking the course link.
| Training | Course objectives | Applicable to |
|---|---|---|
| ** | Introduction to Privacy and Security for Personal Information (PI) and Personal Health Information (PHI) in the research environment | All researchers and research team members conducting research involving human participants, including their data and/or biological materials |
| * | Introduction to concepts and principles related to what has come to be known as the Responsible Conduct of Research (RCR) | All researchers and research team members regardless of discipline or career stage |
| * | Introduction to a variety of ethical issues that are important to consider when conducting biomedical research with human participants, not limited to clinical trials. For more advanced users, the Tutorial is an educational tool that will assist in the understanding and appropriate application of ethical principles, guidelines, regulations and legislation when conducting biomedical research | Healthcare providers, academics and people working in the biomedical industry who have an interest in research; researchers and research personnel (e.g., lab assistants, technicians, clinical research staff, research students etc.); Research Ethics Board members, administrators and coordinators; research administrators |
| * | Foundational role-based training for learners needing basic clinical research coordinator (CRC) training or organizations needing onboarding training for new CRCs | CRCs, investigators, and other clinical research professionals |
* These courses are provided by the and made available to the Queen's community through the . To access training courses offered through Queen 国产传媒 鈥檚, please register for a CITI account, using an institutional email address (queensu.ca) and selecting 鈥湽 (N2)鈥 as the organization affiliation.
** This course is provided to the Queen's community by N2. To access, create a , then use the link on the table. If prompted, sign in after clicking the course link.
Resources for clinical research
Queen's University is a member of the and provides affiliated researchers with access to N2 国产传媒 鈥檚 complete set of clinical research standard operating procedures (SOPs) and clinical research templates. These SOPs are compliant with the Tri-Council Policy Statement 2 (TCPS2), International Council for Harmonisation Good Clinical Practice (ICH-GCP) and both Health Canada and United States Food and Drug Administration (U.S. FDA) regulations for clinical research.
The use of these SOPs for clinical research is highly recommended by Queen's. Queen's NetID is required to access the SOPs.
Training is required and must be documented; a training log is provided below in Tools and Templates.
Queen's, Kingston Health Sciences Research Institute (KHSCRI) and Providence Care Hospital (PCH) work in close collaboration on many research initiatives. There are, however, times when SOPs, training and other requirements may vary. Always check with your local administration to ensure requirements have been met.
Clinical trial registration
Clinical trial registration helps to promote transparency in research, prevent publication bias, and reduce duplication of efforts. Per the International Committee of Medical Journal Editors , all clinical trials must be registered at or before the time of first patient consent for enrollment in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the ICMJE. Clinical trial registration and timely registry updates are both a requirement and a condition of consideration for publication per TCPS2 and U.S. National Institutes of Health (NIH) policies.
is the registry used by Queen's University and its affiliated hospitals (Kingston Health Sciences Centre and Providence Care). The Research Compliance team is the administrator for registration of clinical trials whose contracts are managed by 国产传媒. Please contact researchcompliance@queensu.ca for account set-up or additional inquiries.
Registration must be completed by the sponsor or sponsor-investigator for investigator-initiated research.
Once registration is completed, the registry must be maintained and updated by the sponsor or sponsor-investigator as follows:
- Records must be reviewed and verified at least once every 12 months. For ongoing studies, it is recommended that this be done every six months.
- Update registry in a timely manner (within 15 or 30 days) with new information that might affect the welfare or consent of participants, safety and efficacy reports, reasons for stopping a trial early, and/or location of findings.
- Update registry within 30 days in case of changes to individual site status and overall recruitment status and primary completion date.
CIHR-funded clinical trials
If you have received grant funds from the Canadian Institutes of Health Research (CIHR) 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 are 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 U.S. National Institutes of Health funding policy, as well as the .
Starting February 2026, CIHR has implemented a new annual process for monitoring compliance with these requirements and will be publicly reporting on results. To learn more, read the .
Institutional Review Committee for Databases, Biobanks, and Registries
The collection and use of human biological samples and data are critical for advancing medical and health research. In the modern context, we strive for data to be as open as possible, and shared and re-used as appropriate. At the same time, it is critical that data are secure and privacy is protected. Queen 国产传媒 鈥檚 is committed to enhancing data management and governance practices to ensure proper data stewardship.
The Institutional Review Committee for Research Databases, Biobanks and Registries (DBRs) is a newly-convened advisory committee (2026) that aims to provide legal, technical, administrative and operational review for all research DBRs that involve human participants, their data, and/or biospecimens; and that are developed at 国产传媒, Kingston Health Sciences Centre or Providence Care Hospital. The Committee makes recommendations to ensure that DBRs are designed with institutional policies, relevant laws, and best practices for data and biospecimen stewardship in mind.
- New applications submitted to the Research Ethics Boards (REBs) to create DBRs involving human participants and their data and biospecimens
- Amendments to already approved DBRs
- Renewals of DBR applications, as requested
- Closure plans for DBRs
The REBs will continue to provide ethical oversight of DBRs, and will serve as the conduit to the Institutional Review Committee.
When requested, the Institutional Review Committee will be engaged by the REB to provide DBR review. Applicants, as always, will submit a single application through TRAQ for ethical approval.
- Chair: Kelly Blair
- Research Compliance: Ellie Rodgerson
- Data Privacy and Security: Ricardo Smalling
- Clinical or Scientific Expert: Vacant
- Legal and Regulatory: Vacant
- Research Data Management Application Expert: Amal Khalil
- Information Technology and Infrastructure: Paul Muir
- Research Data Management: Becky Pero, Meghan Goodchild
- Environmental Health and Safety: Raico Laria-Lamela
- Delegate from KHSC/PCH: Vacant
- I-EDIAA in Research: Aleksandra Bergier
Need assistance?
If you have questions, our team would be happy to assist you.
Alternatively, you can join our weekly virtual drop-in sessions every Tuesday between 10 - 11 am.