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, and is our primary point of data entry and record managment for clinical trials in BC.
Health Canada and the FDA encourage use of electronic systems in clinical research and it is becoming more common for sponsors to have a dedicated budget for site technology enablement. Below is a list of CTMS features designed to streamline processes for both the research site and monitor, improve data integrity, and increase participant safety during the trial:
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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): 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.
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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.
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Part 11 Compliant Electronic Signatures: Validated electronic signatures dramatically increase efficiency when gathering staff/physician signatures. This feature also maximizes participant safety oversight by allowing timelier physician assessments on lab reports, safety letters, and other critical trial documents. 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. 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 and resolved within eDOCS or eSOURCE supporting improved communication between monitor and site staff. Secure access to the remote Monitor Portal can dramatically cut down travel costs for Sponsors and CROs while facilitating risk-based monitoring.
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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.
