Clinical Research Operations
SickKids is Canada’s largest and most research intensive paediatric hospital. Our cutting-edge research influences the way healthcare is delivered to children both here and around the world.
One third of the research conducted at SickKids is clinical research. The number of scientists, publications, and grants dedicated to clinical research continues to grow and reflects our commitment to achieving excellence in this field.
Clinical Research Operations (CR Ops) supports study teams and helps ensure quality clinical research by providing tools, templates, education, research facilities and services, and oversees regulatory and ethical compliance.
What we do
CR Ops supports research teams throughout their studies, providing:
- Clinical research study activation and navigation support
- Research ethics approvals
- Regulatory submissions
- SickKids-sponsored Health Canada-regulated study set up support
- Study conduct guidance and support, including monitoring
- Clinical Research Centre, including nursing support
- Study Coordinator Services
- REDCap setup
- Research biostatistical and analysis support
- Biobanking services
- Database set up and management support
- Education & training
- Tools & templates
Additional support services
SickKids offers extensive support services for researchers, including assistance with contracts, budget negotiations, patient engagement, database set up and data management, Epic data requests and grant submissions.
Teams
Research Ethics Office
The Research Ethics Office (REO) assists the SickKids Research Ethics Board (REB) with its mandate to ensure clinical research meets current ethical and scientific standards and complies with applicable regulations, guidelines, and policies for ethical conduct of research.
The REO works cross-functionally with Research Operations and Clinical Research Operations teams to ensure a research-centric approach to REB processes and workflows.
Clinical Research Support Office
The Clinical Research Support Office (CRSO) manages the institutional review and approval process for all clinical research studies. It also serves as a central support office for study Principal investigators (PIs), Clinical Research Coordinators (CRCs) and relevant groups across the enterprise.
The CRSO offers a concierge model for research teams to navigate the various project and institutional requirements by triaging information, directing internal stakeholders to the proper services, and bringing Research Operations and service provider teams together to address any challenges or operational blockers.
Regulatory Compliance Office
The mandate of the Regulatory Compliance Office is to facilitate the development, activation and oversight of SickKids-sponsored Health Canada-regulated clinical trials. It also provides training and education for clinical research professionals, trainees, faculty and other clinical research community through the Office of Clinical Research Professionals (OCRP).
Office of Clinical Research Professionals
The Office of Clinical Research Professionals (OCRP) supports clinical research staff at SickKids by coordinating and providing professional development, mentoring, and staff engagement opportunities to promote accountability, excellence and collaboration across the clinical research community of practice.
Clinical Research Core Facilities
The Clinical Research Core Facilities operate on a cost recovery basis and are available to internal and external researchers.
- The Clinical Research Centre (CRC) includes a fully equipped hospital research unit and trained clinical research staff to support all types of clinical research.
- Clinical Research Coordinator Services offers research staff on an as-needed basis to support study start up (approvals process, REB submissions, regulatory documentation and REDCap design) and study conduct (recruitment, consent, visits, documentation)
- SickKids’ Central Biobank offers sample processing, storage and state-of-the-art database management.
- The Analytics Hub offers study feasibility assessments (sample size calculations), methodological advice, research and trial design, statistical analyses, and manuscript/presentation support.
- The Behavioural Assessment Unit (BAU) includes modern observational labs for conducting behavioural and cognitive assessments.
Interested in conducting your clinical research study at a SickKids core facility in Canada? Connect with CR Ops for more information.
Collaborations and opportunities
We collaborate and work with a number of external researchers worldwide to facilitate important studies. If you are interested in conducting research in the SickKids’ Clinical Research Centre, Central Biobank, or looking for a collaborator, get in touch with CR Ops today.
Director, Clinical Research Services Transformation
Senior Manager, Research Ethics Office
Senior Manager, Clinical Research Support Office
Senior Manager, Clinical Research Facilities and Services
Senior Manager, Regulatory Compliance Office, Clinical Research Operations
Working in clinical research at SickKids
The Office of Clinical Research Professionals (OCRP) is the institutional home and voice of clinical research at SickKids - a hub for the support, networking, education and resources clinical research professionals need to elevate research at SickKids. The OCRP helps staff access the best tools, education, and any other resources they require to continue pursuing cutting-edge research.
All new clinical research staff are supported through an onboarding process which includes an introductory email highlighting important resources, an onboarding manual, and enrolment in a three-hour workshop on how to conduct clinical research at SickKids.
The OCRP supports Clinical Research Project Coordinators, Clinical Research Project Managers, Clinical Research Project Assistants, Clinical Research Nurse Coordinators, Clinical Research Nurse Specialists, among others.
