• REB Approval: It is imperative that research involving living human participants, human biological materials, and secondary use of data, health information, or biological materials receive approval from a Research Ethics Board.  Multiple steps are involved in obtaining the certificate of approval for a clinical study to begin.  At CTSU all our processes are based on TCPS2 principles and in adherence with the University of Saskatchewan Ethics Board SOPs. Our CRPs help review, revise and/or develop documents and ensure that the study is conducted to meet the ethical standards set forth in TCPS2 and ICH-GCP. 
  • Complete the Research Ethics Application
  • Develop and/or revise participant Informed Consent Forms (ICF)
  • Apply necessary protocol amendments and obtain approvals
  • Ensure study renewals in a timely manner

• Operational Approval: Studies that use Saskatchewan Health Authority property, resources, facilities, patients or staff require operational approval before the research commences. The CTSU conducts a departmental impact assessment, determines pass-through costs, and obtains SHA operational approval on behalf of the investigator.

• The CTSU compiles regulatory documents for the investigator as required by the regulatory agency governing the research. Additional regulatory support is offered for internal investigator-initiated research.

• Clinical trial budgeting is an essential aspect of running a trial successfully.  At CTSU, CRPs operate as budget specialists to ensure that the budget reflects the full scope of activities with sufficient detail.  We help investigators to assess if all relevant components and activities were included and the appropriateness of the budget for each component. At CTSU we perform risk analysis and assessment of all budget components to ensure successful collaboration between key stakeholders.  We also offer consultancy services to build new budgets for funding applications where USask will act as the sponsor for the study.  

• Confidentiality Disclosure Agreements and Clinical Trial Agreements offered by sponsored are negotiated by CTSU Legal Counsel for investigators utilizing CTSU services only*. If CTSU services will not be utilized, agreements must be sent to Innovation, Mobilization, and Partnerships for legal review and negotiations.

   

  *This is a change in process effective February 2024.

• The CTSU sets up, manages, and reconciles the research fund on behalf of the investigator and bills the sponsor according to the approved budget in the Clinical Trial Agreement. Research pass-through costs are also managed by the CTSU.
• The CTSU invoices the investigator for services and personnel on a quarterly basis and monitors the research fund to ensure it remains sufficient. 

Standard services for start-up are covered by a flat rate administrative fee determined by total contract value. Standard research administrative services required after start-up will be encompassed by an annual site maintenance fee of $2,000 for the duration of the study. Please contact ctsu.operations@usask.ca for more information.

External investigator-initiated studies are studies initiated by a Principal Investigator affiliated with an academic institute other than the University of Saskatchewan and where the institute is acting as the sponsor of the study. Standard services are covered by a subsidized administrative fee determined by total contract value.

Services required after the initial study start-up (e.g., REB amendments, annual renewals, safety reporting, etc.) are not covered by the fee and will be billed according to the fee schedule (available upon request).

Internal investigator-initiated studies are studies initiated by a Principal Investigator within the University of Saskatchewan, where the institute is acting as the sponsor of the study. Standard services are offered on an hourly basis and not determined by contract value.

• The CTSU can assist with site feasibility questionnaires and qualification visits with the caveat that if the study is awarded to the site the investigator will utilize the CTSU for start-up, conduct, and closure of the study.

• Studies involving use of investigational new drugs or devices or "off-label" use of marketed drugs, devices, biologics, or natural health products require Health Canada regulatory approval in the form of a No Objection Letter before the research commences. The CTSU team can assist with the preparation and submission of Clinical Trial Applications or Investigational Device Exemptions.
• Regulatory binder set-up is provided by CTSU Clinical Research Nurses and Coordinators. The CTSU can further provide regulatory inspection assistance for studies sponsored by the University of Saskatchewan. 

• REDCap is a mature, secure web application for building and managing online surveys and databases. This complimentary electronic data capture system is available through the University of Saskatchewan and the CTSU can support REDCap builds.

• The University of Saskatchewan is a member of N2 Network of Networks which offers a full suite of Health Canada and FDA-approved Standard Operating Procedures. N2 SOPs are avialable to N2 members only and cannot be distributed publicly. The CTSU acts as the administrator for N2. Please contact us to request access.

• Clinical trials must be registered on one of two publicly accessible registeries accepting international clinical trial information. The CTSU can assist University of Saskatchewan investigators with clinicaltrials.gov registration. 

• In addition to start-up activities, the CTSU supports ongoing study activities (e.g., renewals, amendments, safety reporting) and study closure.

• The CTSU supports remote and on-site clinical monitoring for Health Canada-regulated studies that are sponsored by the University of Saskatchewan. 

• The CTSU can provide a Clinical Research Coordinator or Clinical Research Nurse to support the conduct of clinical research and trials at local sites. Support is provided at an hourly rate or personnel can be contracted for the required full-time equivalent.