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.

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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.

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Obtain all necessary regulatory, ethics, and institutional approvals to ensure your study is safe, feasible, and compliant with policies.

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Prepare for study initiation by setting up data systems, organizing documentation, training the team, and completing site activation.

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Screen, recruit, and consent eligible participants, then complete medical review and randomization if applicable.

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Collect data and biological samples according to the protocol and SOPs, ensuring accuracy, confidentiality, and proper documentation throughout the study.

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Monitor study conduct to ensure Health Canada compliance by addressing safety and quality issues, auditing as needed, and maintaining site readiness.

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Contacts: PHSA Jessica or BC Cancer PCTO

Manage study finances by tracking expenditures, invoicing, processing payments, managing participant stipends, and reconciling all financial activities.

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Close the study by completing final monitoring, resolving queries, verifying data, submitting required reports, and notifying regulatory authorities.

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Analyze the data according to the statistical analysis plan, and interpret results in the context of research objectives, existing literature, and clinical practice.

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‎Archive the study according to the data management plan, regulations, and institutional policy.

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Prepare, submit, and publish your research, and communicate findings through presentations, reports or peer-reviewed manuscripts.

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Translate findings into practice, assess their impact on care and policy, and monitor dissemination efforts.

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Identify opportunities for further investigation or quality improvement based on your results.

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