Provincial Health Services Authority (PHSA) improves the health of British Columbians by seeking province-wide solutions to specialized health care needs in collaboration with BC health authorities and other partners.
Identify a knowledge gap, formulate a research question to address a clinical problem, review the literature, and outline your project’s goals and methods.
Resources: (Project prospectus template?)
Contacts: (Clinical Librarian to support literature reviews)
Build your project team by securing support, recruiting multidisciplinary members, defining roles, and identifying resource or personnel needs.
Resources:
Contacts:
Develop a detailed clinical protocol by following established guidelines, ensuring feasibility, quality, risk management, and peer review.
Resources: (SPIRIT Guidelines, SEPTRE protocol)
Contacts: QA team to incoporate Quality-by-design principles
Develop all essential supporting documents, service provider contracts, training materials, and oversight plans needed for study execution and compliance.
Obtain all necessary regulatory, ethics, and institutional approvals to ensure your study is safe, feasible, and compliant with policies.
Prepare for study initiation by setting up data systems, organizing documentation, training the team, and completing site activation.
Screen, recruit, and consent eligible participants, then complete medical review and randomization if applicable.
Collect data and biological samples according to the protocol and SOPs, ensuring accuracy, confidentiality, and proper documentation throughout the study.
Monitor study conduct to ensure Health Canada compliance by addressing safety and quality issues, auditing as needed, and maintaining site readiness.
Contacts: PHSA Jessica or BC Cancer PCTO
Manage study finances by tracking expenditures, invoicing, processing payments, managing participant stipends, and reconciling all financial activities.
Close the study by completing final monitoring, resolving queries, verifying data, submitting required reports, and notifying regulatory authorities.
Analyze the data according to the statistical analysis plan, and interpret results in the context of research objectives, existing literature, and clinical practice.
Archive the study according to the data management plan, regulations, and institutional policy.
Prepare, submit, and publish your research, and communicate findings through presentations, reports or peer-reviewed manuscripts.
Translate findings into practice, assess their impact on care and policy, and monitor dissemination efforts.
Identify opportunities for further investigation or quality improvement based on your results.
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