Our Services
As an academic coordinating centre, CCTS provides full services to support investigator initiated clinical research, whether single-centre, multi-centre, or international.
IMPORTANT Note: All SRI-sponsored investigator-initiated regulated clinical trials must undergo a CCTS intake assessment to ensure the necessary regulatory support and processes are in place.
How to access services and available supports
To initiate the CCTS intake process, please complete the CCTS Intake Form and submit to CCTS@sunnybrook.ca.
If your project is not a regulated clinical trial, and you are looking for REDCap services only, please complete the CCTS Intake Form REDCap only and submit to CCTS@sunnybrook.ca.
CCTS services and available support include, but are not limited to:
Project development »
- Protocol quality review
- Regulatory assessment
- Budget development
- Statistical support
Project management »
- Contract management
- Monitoring services
- Monitoring plan development
- Site initiation visits, interim monitoring and closeout visits
- Review of monitoring reports
- Pre-inspection visit
- Facilitate regulatory inspections
- Education and training of monitors/auditors
- Risk-based monitoring approach
- On-site monitoring
- Remote monitoring
- Regulatory services
- Clinical Trial Application (CTA) review
- Clinical Trial Site Information (CTSI) preparation and submission
- Qualified Investigator Undertaking (QIU) preparing and filing
- Safety reporting
- On-site inspection support
- Activation activities
- Trial Master File preparation and maintenance
- Trial registration
- Site selection
- Site activation process
- Education and training of sites
- Communications
- Investigator meetings
- Teleconferences and webinars
- Central study contact
- Investigational product
- Study drug/device supply management
- Teleconferences and webinars
- Safety management
- AE reporting plan
- Results dissemination
- Manuscript and abstract preparation
Data management »
- Electronic data management system
- Data analysis plans and reports
- CRF/eCRF design
- eCRF programming
- Programming validation
- Query management
- Randomization schemes
- Security parameters
- Integration with other data sources
- Systems meet industry standards
- AE/con med coding
- Interim and final analyses
- Overdue data and query reports
- Central data management
Finance management »
In collaboration with SRI finance and grant agencies:
- Budget monitoring
- Monthly reconciliation of funds
- Dissemination of site payments, invoices and reimbursements
- Grantee statement or financial reports verification
