PHSA sites manage clinical trials using RealTime CTMS.
RealTime Clinical Trial Management System (CTMS) is a cloud-based system for managing participant screening and enrollment logs (including personal identifiers), study visits, milestones, financial data (including invoicing), and electronic regulatory documentation (eDOCS) in one centralized location. The RealTime CTMS platform is privacy and security approved for use in British Columbia.
Health Canada and the FDA encourage use of electronic systems in clinical research. Below is a list of CTMS features designed to streamline processes for both the research site and monitor, improve data integrity, ensure regulatory compliance, and increase participant safety:
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Higher Quality and More Timely Data: Electronic processes improve/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.
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Secure Electronic Investigator Site Files (ISF): All records saved within the system are securely stored with version control and a thorough data security/backup plan. Includes regulatory-compliant electronic delegation logs.
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Complete Audit Trails and Data Control: Audit trails and data controls are maintained within the system to improve accountability and data integrity.
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Part 11 Compliant Electronic Signatures: Validated electronic signatures dramatically increase efficiency when gathering staff/physician signatures. Documents can be securely signed from anywhere to record evidence of training, delegation, or study oversight.
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Remote Portal Access: Online access allows research staff and monitors to collaborate more effectively during the study to facilitate monitoring activities, sponsor audits, and regulatory inspections.
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End-to-End Technology Infrastructure: In addition to the popular eDOCS regulatory platform, RealTime CTMS at PHSA includes the option to use Website Integration, Mobile App, eSOURCE (electronic source documents), Text, Participant Portal and eCONSENT.
PHSA Corporate Research Services administers PHSA's Provincial CTMS Program in partnership with Michael Smith Health Research BC.
BC Cancer implemented RealTime CTMS in 2019 to manage all registered, interventional clinical trials. RealTime CTMS use was extended to other PHSA research organizations and regional health authorities in 2020.
