Clinical Trial Management System (CTMS) is a cloud-based management platform that integrates all clinical trial activities into one centralized place, streamlining the administrative process of clinical trials.

Research teams can manage:

  • Participant screening and enrollment logs
  • Study visits
  • Financial data and invoicing
  • Remote monitoring
  • Electronic regulatory documentation (eDOCS) on the platform.

This provincial initiative is in collaboration with Provincial Health Services Authority, Fraser Health, Island Health, Northern Health, Interior Health and Providence Health. 

The RealTime CTMS is open to all clinical research teams at VCHRI for industry-sponsored and investigator-initiated studies.

Key benefits

  • Higher quality and more timely data: Electronic processes improve and reduce timelines, increase productivity and ensure trials run smoothly. Elimination of paper-based processes allow investigators and site staff to spend more time on participant care and less time on training, resulting in improved oversight and accelerated overall trial progress.
  • Secure electronic Investigator Site Files (ISF): Records are securely stored with version control and a robust data security and backup plan. All records are encrypted for maximum security, and the system includes validated electronic Delegation Logs. Electronic archiving supports Health Canada's 15-year retention requirement for essential study documents.
  • Complete audit trails and data control: Audit trails and data controls are maintained within the system for users to reconstruct the time of events and prevent human errors during data collection. These features improve accountability and data integrity.
  • Part 11 compliant electronic signatures: Validated electronic signatures dramatically increase efficiency when gathering staff or physician signatures. This feature also maximizes participant safety letters and other critical trial documents. Documents can be securely signed from anywhere to record evidence of training, delegation or study oversight.
  • Remote portal access: Online access allows research staff and monitors to collaborate more effectively during the study. The research site can grant access to study records at any time during or after the study. This portal can also be used to facilitate monitoring activities, sponsor audits and regulatory inspections. Queries can be posted an resolved within eDOCS, supporting improved communication between monitor and site staff. Secure access to the remote Monitor Portal can dramatically cut travel costs for sponsors and CROs while facilitating risk-based monitoring.

Costs

Please contact Lauren Yee for more information on CTMS costs.

Data privacy and security

RealTime CTMS has undergone a privacy impact assessment (PIA) and security threat risk assessment (STRA) at the provincial level. Health Canada* and the FDA encourage the use of electronic systems in clinical research. The platform is compliant with regulatory requirements for Health Canada and the FDA (FDA 21 CFR part-11). 

*Note: Health Canada does not approve any software, and it is the user's responsibility to comply with all Health Canada regulations.

CTMS onboarding checklist

  1. Attend CTMS demonstration and walkthrough session.
  2. Identify the CTMS modules and features of interest to your research team.
  3. Complete and submit the New Site Form.*
  4. Complete and submit the User Log.*
  5. Complete and submit the New Study Form.*
  6. Participate in CTMS user training sessions according to your study role:
    • General introduction
    • Study management
    • Administrator training
    • eDOCS
    • Study templates
    • Finance
  7. Complete study template build.

*Note: Steps 3, 4 and 5 may be completed simultaneously.

Please reach out directly to Lauren Yee at lauren.yee@vch.ca to arrange a platform demo, for access to forms and with any questions or concerns.

CTMS Demo & Inquiries