This page provides a collection of resources that can help with the implementation of Decentralized Clinical Trials (DCTs) processes in British Columbia. The resources aim to offer framework, guidance, considerations, and supporting digital solutions in conducting DCTs throughout the province.
CRAFT — A Proposed Framework for Decentralized Clinical Trials Participation in Canada
Sundquist S, Batist G, Brodeur-Robb K, Dyck K, Eigl BJ, Lee DK, Limoges J, Longstaff H, Pankovich J, Sadura A, Sullivan P, Dancey JE. CRAFT—A Proposed Framework for Decentralized Clinical Trials Participation in Canada. Current Oncology. 2021; 28(5):3857-3865. https://doi.org/10.3390/curroncol28050329
Read the full review:
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Apostolaros, M., Babaian, D., Corneli, A. et al. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci 54, 779–787 (2020). https://doi.org/10.1007/s43441-019-00006-4
Read the full article:
RealTime Clinical Trials Management System
A Clinical Trial Management System (CTMS) is a critical tool for improving the clinical research process at both the site and institutional level. British Columbia’s harmonized CTMS program maintains and manages planning, performing, and reporting functions, along with tracking participant visits, study milestones, and trial financial data. Additionally, our CTMS offers research teams access to a powerful module known as eDOCS, which provides the ability to upload essential study documents to a secure electronic regulatory binder.Image
eDOCS is a validated system that improves efficiency for the entire research team, and is both FDA Part 11 and PIC/S Annex 11 compliant. As a cloud-based system, eDOCS allows team members to securely access their documents remotely. The integrated e-signature capabilities also allow qualified investigators to sign documents quickly from wherever their busy schedules may take them. With highly customizable templates, eDOCS automates workflows and eliminates redundant filing across multiple studies. It also includes a remote-monitoring portal, which allows secure, limited access to monitors anywhere in the world. Finally, with unlimited storage and digital archiving, eDOCS ensures that all of your essential study documents are secure and accessible for as long as you need them.
Learn more about the Provincial Clinical Trials Management System Program:
REACH BC is connecting British Columbians with researchers, to advance all kinds of health research here in BC, with the aim to make health care better for everyone.
Connect with the Public
REACH BC makes it easier for you to connect with potential research participants and patient partners. It gives you access to a broad population across BC—in urban and rural settings, across multiple health authorities. REACH BC matches you with interested volunteers, who you can review and select as study participants or patient partners.
Learn more about REACH BC:
Michael Smith Health Research BC's REDCap for Clinical TrialsImage
REDCap (Research Electronic Data Capture), a secure, sophisticated web application for building and managing online surveys and databases, is now available for health researchers in BC. Licensing of REDCap through the former BC Academic Health Sciences Network (now Michael Smith Health Research BC) enables us to support researchers across the province.
The Michael Smith Health Research BC's REDCap data collection platform has been validated to comply with Health Canada’s regulations on data collection software. The validation process has confirmed that all parts of the REDCAP platform function as expected, ensuring it is a reliable and secure tool to run all sorts of research studies.
This is particularly important for the REDCap use in clinical trials. Please note that for clinical trials to be fully validated, good data management practices must be followed throughout the entire lifecycle of the trial. This includes ensuring proper testing and validation of the study data design and implementation.
Please review REDCap’s procedures, good practices and recommendations, as well as the validation certification for this REDCap instance here: https://www.popdata.bc.ca/researchers/resources/REDCap
- Data quality checks, data resolution workflow
- Record locking and e-signature
- Data access groups
- And more
Michael Smith Health Research BC is serving the whole BC Research Community, optimizing efforts and avoiding duplication measures between institutions and health authorities across the province. All clinical trials and research initiatives across BC are welcome to use this validated instance to run their studies in a regulated and robust environment.
Watch this webinar recording to learn more about REDCap's features and how to get access and set up to the system:
Learn more about REDCap for Clinical Trials:
The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.
DTRA Organizational Membership
Decentralized Trials & Research Alliance Members represent the diverse ecosystem required to support the adoption of decentralized research methods.
Organizational Members include pharmaceutical and biotechnology companies, regulatory authorities, patient/advocacy organizations, clinical research organizations, technology companies, specialized service providers, investigator site networks, consulting organizations, and other stakeholders.
Learn more about DTRA and its organizational membership:
- Gergova, V.T., Serbezova, A.H., Sidjimova, D.A. Analysis On Decentralized Clinical Trials In Some European Countries. Archives of the Balkan Medical Union vol. 56, no. 4, pp. 394-401 (2021). https://doi.org/10.31688/ABMU.2021.56.4.01
- Izmailova, E.S., Ellis, R., Benko, C. Remote monitoring in clinical trials during the COVID-19 pandemic. Clin. Transl. Sci. (2020) 13, 838–841; https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12834
- Re-Envisioning Clinical Trials During The COVID-19 Pandemic, Health Affairs Blog, July 8, 2020. DOI: 10.1377/hblog20200702.963588