Compliance and Training for Human Participants Research

The Research Compliance and Training team is dedicated to fostering a culture of compliance in human participant research.  The team aims to promote quality, streamline processes, improve efficiency, and minimize risks of harm.  

Compliance and Training resources and supports for all types of human participant research can be found under one of the streams below: 

Training

Covering applicable policies, procedures, ethical policies and guidelines, regulations and more.

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Resources

SOPs, templates and guides for clinical research and clinical trial registration.

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Guidance

Available throughout the life cycle of your research project for all types of studies that involve human participants.

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Oversight

Oversight services to assist your team throughout the life-cycle of your research project including Compliance readiness reviews and Inspection preparation.

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For questions or additional information, please reach out to the Compliance and Training Team.

A variety of instructional resources are available to help members of the Queen’s Research Community confidently engage in ethical and compliant research involving human participants.  

For questions, additional information, or a missing topic, please reach out to the Compliance and Training Team.

MANDATORY

Applicable to What Time How
All Queen’s University and affiliated hospital researchers conducting research involving human participants, including their data and/or biological materials. TCPS 2: CORE-2022 Tutorial 2.5-4 hours https://tcps2core.ca/welcome 
All researchers and research team members involved in clinical trials
 
Good Clinical Practice (GCP) 3-4 hours https://www.queensu.ca/vpr/ethics/citi
Plus applicable regulatory training:
Drugs - Health Canada Division 5 (food and drug regulations, Part C, division 5 3-4 hours https://www.queensu.ca/vpr/ethics/citi
Natural Health Products - PART 4 - Clinical Trials Involving Human Subjects 1-2 hours Self-directed 
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/
Medical Devices - PART 3 - Medical Devices for Investigational Testing Involving Human Subjects 1-2 hours Self-directed 
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

RECOMMENDED

Applicable to What How
An introductory course on Privacy and Security for Personal Information (PI) and Personal Health Information (PHI) in the research environment. Foundations in Privacy in research. https://www.queensu.ca/vpr/ethics/privacyinresearch
Recommended for all researchers regardless of discipline or career stage. Responsible Conduct of Research (RCR): This module introduces concepts and principles related to what has come to be known as the Responsible Conduct of Research (RCR). https://www.queensu.ca/vpr/ethics/citi
  • 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 (REB) members, administrators and coordinators
  • Research administrators
Biomedical Research:
an 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.
Intended for CRCs, investigators, and other clinical research professionals;  intended as foundational role-based training for learners needing basic CRC training or organizations needing on-boarding training for new CRCs. Clinical Research Coordinator

Supporting the compliant conduct of human participant research by providing: 

  • Standard operating Procedures for Clinical Research 
  • Tools and templates 
  • Clinical Trial Registration

For questions or additional information, please reach out to the Compliance and Training Team.

Standard Operating Procedures for Clinical Research:

Queen's University is a member of the Network of Networks (N2) and provides affiliated researchers with access to N2’s complete set of Clinical Research Standard Operating Procedures (SOPs) and clinical research templates.   These SOPs are compliant with TCPS2, ICH-GCP and both HC and US FDA regulations for clinical research.

Use of these SOPs for clinical research is highly recommended by the Compliance and Training team.  For affiliated hospital-based research, please consult with the KGHRI and PCC research teams for requirements.  If used, training is required and must be documented; a Training log is provided below.  
 

 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

Tools and Templates for Clinical Research

The Compliance and Training team is currently developing resources for Investigator-initiated clinical trials but through our membership in the Network of Networks (N2), we have access to N2’s complete set of Clinical Research tools and templates.  Didn’t find what you are looking for?  please reach out to the Compliance and Training Team.

 Queen's NETID is required to access the Tools and Templates
 Tools and Templates


Clinical Trial Registration

Clinical trial registration helps to promote transparency in research, prevent publication bias, and reduce duplication of efforts.  Registration in a publicly accessible registry that is acceptable to World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE). is required before recruitment prior to the first participant visit per TCPS2 and NIH policies. 

Registration is completed by the sponsor or sponsor-investigator for investigator-initiated research.

The registry that is used by Queen's University and its affiliated hospitals (KHSC and PCC) is clinicaltrials.gov  

For assistance with this process, please contact the Compliance and Training Team, or the research teams at the affiliated hospitals (kghri@kingstonhsc.ca, research@providencecare.ca)

Once registered, the registry must be maintained and updated in a timely manner as follows:

  • clinicaltrials.gov records must be reviewed and verified at least once every 12 months.  For ongoing studies, it is recommended that this be done every 6 months.
  • In a timely manner (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
    • the location of findings
    • Individual site status and overall recruitment status  (within 30 days of the change)
    • Primary completion date (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

The Compliance Team 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, from anonymous surveys to interventional new drug clinical trials.

Please reach out to the Compliance and Training Team.

The Compliance Team provides oversight of human participant research.  We handle reports of alleged non-compliance and work closely with the Research Ethics Office and the research teams at the affiliated hospitals.  While the human participants protection program is currently under development, we are pleased to offer various oversight services including compliance readiness reviews and inspection preparation. 

Please reach out to the Compliance and Training Team.

Weekly virtual drop-in session

The Compliance and Training team are hosting weekly virtual drop-in sessions starting June 1, held every Tuesday between 10 - 11 am.

The aim is to support our research community the ethical and compliant conduct of human participant research throughout the life cycle of a research project - from concept through to study closeout and publication.  If we cannot answer your question in 5 minutes, we will arrange a separate meeting to help you navigate.
 

Join a virtual drop-in session

 Compliance and Training team

silhouette ashley theis

Ashley Theis

Associate Director, Research Compliance and Training

ashley.theis@queensu.ca

355 King St. West

silhouette Christopher Boot

Christopher Boot

Compliance Advisor

cboot@queensu.ca

355 King St. West