Skip to main content

Main menu

  • About Us
    • Leadership
    • Our Team
    • Vision, Mission and Values
    • Health and Economic Impact
    • Strategic Plan
  • Our Research
    • Research Focus
      • Brain Health
      • Cancer
      • Cardiovascular Conditions and Diseases
      • Digital Health
      • Health Policy
      • Immunity and Infectious Diseases
      • Joint Health and Mobility
      • Respiratory and Lung Health
      • Spinal Cord Injury and Rehabilitation
    • Research Centres and Programs
      • BC Centre on Substance Use
      • Centre for Aging SMART
      • Centre for Cardiovascular Innovation
      • Centre for Clinical Epidemiology and Evaluation
      • Centre for Lung Health
      • Djavad Mowafaghian Centre for Brain Health
      • Immunity and Infection Research Centre
      • International Collaboration On Repair Discoveries
      • Ovarian Cancer Research Centre
      • Vancouver Prostate Centre
      • Community Research Program
      • Emergency Medicine Research Program
      • Hematology Research Program
      • Skin Research Program
      • Other Research Focus Areas
    • News and Stories
    • Researcher Directory
    • Events and Workshops
  • Research Services
    • New to VCHRI
      • Working at VCHRI
      • Regulations and Training
      • Membership with VCHRI
    • Starting Your Project
      • Research Facilitation
      • Awards and Funding
      • Grant Management
      • Operational Approval
      • CST Cerner
    • Developing Your Project
      • Clinical Trials Administration
      • Clinical Research Unit
      • Research Privacy
      • Financial Policies and Procedures
    • Additional Support
      • Education and Training
      • Communications and Branding
      • Media Relations
      • Study Recruitment Support
      • Innovation and Industry Partnership
    • Internal Awards
    • Clinical Research
    • Innovation and Partnership
  • Participate in Research
    • Reasons to Participate
    • Participant Stories
    • Find a Study
    • Recruitment Support

User menu

  • Log in

Breadcrumb

  1. Home

RealTime CTMS at VCHRI

Clinical Trial Management System (CTMS) is a cloud-based management platform designed to streamline the administrative process of clinical trials. The platform integrates all clinical trial activities into one centralized place, allowing research teams to easily access, monitor and track data. 

This provincial project is in collaboration with Vancouver Coastal Health, Provincial Health Services Authority, Fraser Health, Island Health, Northern Health and Interior Health. 

The program is actively seeking participants and is open to demo requests (see contact information below) for all clinical sites within VCH. Participants can include, but are not limited to, investigators and research coordinators conducting clinical trials, industry-sponsored and investigator-initiated studies, and single/multi-site studies.

Key Features

  • Security & Privacy - Store clinical trial data on the CTMS platform that has passed security and privacy assessment both provincially and at Vancouver Coastal Health.
  • Simplified Administrative Processes - Monitor all operational activities in real time to reduce duplication of work and improve workflow between team members via version control and eSignature.
  • Improved Financial Management - Build budgets with visual templates. Create and reconcile payments using a secure invoicing system.
  • Real-Time Insight into Operations - A central place for track studies, budgeting, accounting and offering easy access to important information.
  • Remote Monitoring Capacities - Online access for sponsors/monitors to review, track and issue queries on electronic regulatory documents.
  • Integration - Easily schedule study specific visits in the CTMS and receive Outlook event calendar as a reminder.

Costs and Additional Features

Funding is provided by Michael Smith Health Research BC (previously known as BC Academic Health Sciences Network). Most CTMS services are free of charge. There are also features available at additional cost as follows: 

  • eDocs offers one secure location for quick access to investigator site files for staff, doctors, monitors and auditors. It can be used to store multiple protocol amendments through version control. It also supports bulk signatures allowing for multiple signings of a document from authorized users.
  • ePay (SitePay) utilizes instant issue compensation cards by Mastercard® and VISA® for quick, easy and secure stipend payments to research subjects.
  • eText is an integrated feature that provides SMS text messaging to research subjects as well as site staff for various types of notifications, including:
    • Scheduling confirmation texts
    • 24-hour appointment reminders
    • Cancellation texts
    • Re-scheduling texts
    • Study staff appointment texts

See CTMS Information Sheet for additional information.

Data Privacy

RealTime CTMS has undergone a privacy impact assessment (PIA) and security threat risk assessment (STRA). CTMS is also compliant with regulatory requirements for Health Canada* and the FDA (FDA 21 CFR part-11).

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

General Security

Realtime CTMS is currently being hosted by an external service provider, Atlantic.NET, which is International Organization for Standardization (ISO) certified and complies with industry standards. It has recently migrated to Amazon Web Services in Montreal. RealTime workstations have malware protection, antivirus protection and local firewall protection, and all workstation storage is encrypted.  

ICF Requirements with CTMS

The BC Common Clinical Informed Consent Form (ICF) template used by participating organizations does not require extensive detail on which CTMS software a clinical trial team/organization may be using to conduct a given trial.  

In accordance with Clinical Trials BC and research ethics representatives, no additional information is required in the informed consent form regarding the use of the RealTime CTMS. The following statement is sufficient for inclusion: "Information that contains your identity will remain only with the Principal Investigator and/or designate." 

Data Storage

All server and data storage facilities are in Canada. Access from outside of Canada is possible; however, all data transmission is encrypted. In a situation where the contract with RealTime is not renewed, or an organization decides they no longer wish to use the RealTime CTMS, the data stored in RealTime/Atlantic.NET servers will be returned to the organization and any copies in custody of RealTime will be destroyed in a timely manner. BC AHSN will request a certificate of destruction on behalf of the organization. 

Electronic data destruction methods used by RealTime and Atlantic.NET comply with ISO standards and meet US federal requirements under HIPAA.  

Each organization currently has procedures in place for the classification and destruction of paper documents in accordance with their privacy and security policies.  

CTMS and CST Cerner

Although Cerner has announced clinical trial tracking, it is currently not able to integrate with the RealTime CTMS. 

Resources

  • CTMS Information Sheet
  • Michael Smith Health Research BC - Clinical Trials BC is currently working towards integrating RealTime CTMS to all Health Authorities across BC.    

CTMS Demo & Inquiries

Andy Kim

Clinical Research Systems and Process Improvement Specialist

604-875-4111 x 22781
andy.kim@vch.ca

Get updates!

Join our newsletter mailing list to stay up to date on features and releases.

Subscribe

Quick Links

  • News and Stories
  • Careers
  • Events
  • Media Enquiries

Follow Us

  • Twitter
  • LinkedIn

© 2023 VCHRI. All rights reserved.

  • Contact
  • Privacy Policy