Clinical Trial Services Office (CTSO)

Clinical Trial Services Office (CTSO)

Trial Coordination Unit (TCU)

Planning meeting

Coming soon!

Officially launching fall 2026

The Trial Coordination Unit (TCU) is the Clinical Trial Services Office's dedicated service for industry-sponsored clinical trial start-up at The Ottawa Hospital, providing optional centralized support from trial opportunity through study activation.

Overview

The Trial Coordination Unit (TCU) delivers the Clinical Trial Services Office’s (CTSO) optional, centralized start-up services for industry-sponsored clinical trials at The Ottawa Hospital. 

Operated by clinical research staff and specialists, the TCU provides coordinated support across two key areas of study start-up: site selection and study activation. Services include feasibility review, sponsor qualification, ethics coordination, budget and contract support, departmental engagement, and activation readiness activities.

Flexible service options range from targeted, task-based support to comprehensive, end-to-end management, helping provide a coordinated and consistent pathway to study activation. Please see Service options and cost below for details on the service options available.

Getting started

To get started: Submit the CTSO Intake Form*, which captures protocol details, timelines, and operational needs.

*only available internally

Submit CTSO Intake Form

When TCU services are selected within the CTSO intake form, an email confirmation will be sent to the submitter with a booking link to schedule the Initial Consultation with TCU.

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TCU Reviews Submission

TCU will review the initial intake submission to confirm service eligibility, assess study requirements, and identify any discussion points for the Initial Consultation.

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Initial Consultation Meeting

TCU and the Investigator and/or Study Team meet to review the study's needs and determine the most appropriate level of support.

Zoom Meeting

Review and Sign Service Plan

TCU will prepare a Service Plan outlining the agreed-upon services based on the Initial Consultation. Once the Service Plan is approved and signed, study support can begin.

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Kickoff Meeting

The Kickoff Meeting provides an opportunity to review study requirements, discuss institutional considerations, and establish communication expectations, including meeting frequency and key milestones.

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Service Delivery Begins

With goals aligned and expectations established, TCU begins delivering coordinated support tailored to your study's needs.

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How we support your study

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Site selection services

  • Evaluate scientific, institutional, and resource feasibility
  • Identify risks, constraints, and recruitment considerations
  • Engage impacted departments and support sponsor discussions
  • Complete sponsor questionnaires and submission packages
  • Prepare investigators for site selection interactions and visits
  • Coordinate sponsor requests and follow-up
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Study activation services

  • Prepare, submit, and manage Research Ethics Board (REB) applications
  • Draft study-specific Informed Consent Forms (ICFs)
  • Facilitate French translation of documents, when required
  • Review and align sponsor budget with OHRI standards
  • Coordinate contract negotiation and execution
  • Confirm departmental capacity and requirements
  • Coordinate departmental impact forms and approvals
  • Coordinate pharmacy, diagnostic imaging, and other EPIC order set integrations
  • Compile and track regulatory documents in an electronic Investigator Site File (eISF)
  • Maintain version control and completeness
  • Confirm readiness across all activation domains
  • Submit and activate EPIC RSH study record, as applicable
  • Provide structured handoff to the study team
  • Maintain structured communication cadence
  • Track risks, dependencies, and status updates

Service options and cost

Choose between two service options depending on the level of support required: Tailored Activation Activities or Full-Service Activation Package. 

 

Tailored Activation Activities

Full-Service Activation Package

What it is

Flexible support for specific start-up   activities based on your study needs. Complete, end-to-end coordination from site selection through study activation.

Best for 

Investigators/teams with existing start-up capacity that need additional expertise or support.Investigators/teams seeking comprehensive, single point of coordination through study start-up.2

Cost1

Custom quote provided following intake and consultation. Billed based on services provided using institutional salary-based rates.Funded through negotiated sponsor start-up funding.

1 Billing occurs at study handoff.

2 Full Service Activation timelines depend on sponsor responsiveness and departmental requirements.

Need help deciding? 

CTSO will help determine the most appropriate level of support during the intake and consultation process.

View the CTSO Service Catalogue on IRISGuide* to review a comprehensive, detailed description of available service options.

*only available internally

Contact us

Your partner in clinical trial success

Supporting investigators, sponsors, and research teams through every stage of clinical trial activation.

Ready to get started? Contact us!