The Clinical Trial Support Unit (CTSU) is a centralized clinical research resource that standardizes clinical and administrative procedures for the conduct of human research. The CTSU is a joint initiative of the University of Saskatchewan, Saskatchewan Health Authority and Saskatchewan Cancer Agency, and the Saskatchewan Centre for Patient-Oriented Research and provides investigators at the three member institutions with the resources and knowledge needed to conduct clinical research. It does so in a manner that follows good clinical practice guidelines and withstands legal scrutiny.

 Room 5681 C Wing 8:30 a.m. - 4:30 p.m.

About Us

The CTSU Member's Executive committee oversees the CTSU's leadership and administration. The Members' Executive includes representation from the CTSU's three member organizations (University of SaskatchewanSaskatchewan Health Authority and Saskatchewan Cancer Agency), as well as the Saskatchewan Centre for Patient-Oriented Research and the community of patients and families involved with CTSU-supported research.
Voting Members Position Organization
Dr. Marek Radomski (Chair) Vice-Dean Research, College of Medicine University of Saskatchewan
Dr. Darcy Marciniuk Associate Vice-President Research, College of Medicine University of Saskatchewan
Dr. Brandy Winquist Executive Director, Academics and Learning Saskatchewan Health Authority
Dr. Elan Paluck Director of Research Saskatchewan Health Authority
Ms. Lynn Dwernynchuk Director, Clinical Research Saskatchewan Cancer Agency
Ms. Jackie Mann Executive Director Saskatchewan Centre for Patient-Oriented Research (SCPOR)
Mr. Ron Wheeler Patients' Representative
Non-Voting Members Position Organization
Ms. Sandra Baptiste Manager, Financial Reporting, People and Resources, Financial Services University of Saskatchewan

The CTSU team facilitates collaboration between researchers and research sponsors through a clinical trial process that includes identifying potential investigators for sponsors’ clinical trials, expediting confidential disclosure agreements, negotiating clinical research contracts and budgets, and providing other support services to help investigators successfully complete their clinical studies.

Team Member Position Team Member Position
Diana Fedosoff  Research Financial Analyst Yessica Lopez Hernandez Clinical Research Coordinator
Suzanne Heffernan Research Finance Coordinator Amrita Sharma
Clinical Research Coordinator
Kerry O'Shea Legal Counsel Nicole Sylvain Clinical Research Coordinator
Stefany Cornea Juniot Project Coordinator Twyla Bode Clinical Research Nurse
Whitney Duff Clinical Research Lead Kala Bolt
Clinical Research Nurse
Sydnie Gengler Administrative Coordinator Joanne Boyer Clinical Research Nurse
Erin Barbour-Tuck Clinical Research Professional Kaitlyn Foster
Clinical Research Nurse
Simona Meier Clinical Research Professional Nancy Hodgson Clinical Research Nurse
Rashmi Nagaraj
Clinical Research Professional Dawn Johnson
Clinical Research Nurse
Valeryia Rzheuskaya Clinical Research Professional Emily Junk
Clinical Research Nurse
Sharleen Weese Maley Clinical Research Professional Ray (Wei) Li Clinical Research Nurse
Nurudeen Bello Clinical Research Coordinator Doris Newmeyer Clinical Research Nurse
Andrea DesRoches Clinical Research Coordinator Anne Sperling
Clinical Research Nurse
Helga Halfinger Clinical Research Coordinator

 

Each new clinical trial requires study start-up administration. The administrative fee covers the labor provided by the Clinical Research Professional and other administrative support for industry-funded studies. There is a tiered administrative fee structure for external investigator-initiated trials and subsidized hourly rate for internal investigator-initiated trials.

Services and Rates

The standard study start-up services will be provided and charged out at a tiered hourly rate.

Study Start-Up Administrative Services
Research Ethics Board Application
Budget Development and Negotiations
Saskatchewan Health Authority Operational Approval
Financial Services
Compilation of Regulatory Documents

Additional services are offered at a tiered hourly rate as requested.

Additional Services 
Consent Form Development Study Registration (clinicaltrials.gov)
Protocol Development Health Canada Clinical Trial Application (drug)
Budget Development Health Canada Medical Device Investigational Testing Authorization Application (device)
Ongoing Trial Activities (Renewals, Amendments) Regulatory Binder Set-Up
Multi-site Coordinating Centre Activities Regulatory Inspection Assistance

We will continue to provide a tiered hourly rate for Clinical Research Nurse, Coordinator, and Professional time which is subsidized for investigator-initiated trials.

Service Investigator-Initiated Hourly Rate 
Clinical Research Nurse $60
Clinical Research Coordinator (Non-RN) $45
Clinical Research Professional $50
Clinical Research Associate (Monitor) $50
Data Management $55
Multi-site Management $60

Study Start-Up Administrative Services
Research Ethics Board Application
Budget Development and Negotiations
Saskatchewan Health Authority Operational Approval
Financial Services
Compilation of Regulatory Documents

The standard study start-up services will be charged at the tiered administrative fee determined by total contract value.

Total Contract Value Administrative Fee
$0 - $4,999 $500
$5,000 - $9,999 $1,000
$10,000 - $14,999 $1,500
$15,000 - $29,999 $2,000
$30,000 $3,000

Clinical Research Nurses and Coordinators and other services are billed hourly to studies. If Clinical Research Professional services are required after the initial study start-up (e.g., REB amendments, annual renewals, safety reporting, etc.) covered by the administrative fee, their time will be billed according to the fee schedule.

Service Investigator-Initiated Hourly Rate 
Clinical Research Nurse $60
Clinical Research Coordinator (Non-RN) $45
Clinical Research Professional $50
Clinical Research Associate (Monitor) $50
Data Management $55
Multi-site Management $80
Study Start-Up Administrative Services
Research Ethics Board Application
Budget Development and Negotiations
Saskatchewan Health Authority Operational Approval
Financial Services
Compilation of Regulatory Documents

The standard study start-up services will be charged at the administrative fee determined by total contract value.

Total Contract Value Administrative Fee
$0 - $24,999 $3,000
$25,000 - $49,999 $5,000
≥ $50,000 $7,500

Clinical Research Nurses and Coordinators and other services are offered at an hourly rate for industry-funded studies as well. If Clinical Research Professional services are required after the initial study start-up (e.g., REB amendments, annual renewals, safety reporting, etc.) covered by the administrative fee, their time will be billed at an hourly rate.

Service Industry-Funded Hourly Rate 
Clinical Research Nurse $80
Clinical Research Coordinator (Non-RN) $60
Clinical Research Professional $75
Clinical Research Associate (Monitor) $75
Data Management $55
Multi-site Management $100

CTSU Co-authorship Policy

The International Committee of Medical Journal Editors (ICMJE) defines an individual as an author based on the following four criteria:

  1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  2. Drafting the work or revising it critically for important intellectual content; AND
  3. Final approval of the version to be published; AND
  4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Please also refer to the University of Saskatchewan's Responsible Conduct of Research Policy.

   
Our policy is to request inclusion as co-authors on the final publication if warranted based on ICMJE and USask definitions. If CTSU staff have supported the project but do not meet authorship criteria, recognition of contributions in the Acknowledgements section should be considered.