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

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 Demo & Inquiries