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Research Process Map

Clinical research starts with a big question and ends with better care. The steps below will guide you through designing a study, getting approvals, enrolling participants, collecting and analyzing data, and sharing your findings.

Project development

Identify a knowledge gap, formulate a research question to address a clinical problem, review the literature, and outline your project's goals and methods.


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Build your project team by securing support, recruiting multidisciplinary members, defining roles, and identifying resource or personnel needs.


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Develop a detailed clinical protocol by following established guidelines, ensuring feasibility, quality, risk management, statistical analysis planning, and peer review.


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Secure funding by developing a budget, identifying potential funding sources, and preparing and submitting grant applications.


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Secure funding by developing a budget, identifying potential funding sources, and preparing and submitting grant applications.


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Secure funding by developing a budget, identifying potential funding sources, and preparing and submitting grant applications.


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Content

 Project set-up

Develop all essential supporting documents, service provider contracts, training materials, and oversight plans needed for study execution and compliance.


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  • PHSA Clinical Trials Resource Library offers SOPs, guidance documents, work instructions, forms, and templates for both participating sites and investigators conducting their own studies (network connection required)
  • 'Compliance Corner' eDOCS folders in every PHSA instance of RealTime CTMS contain key processes, forms, and templates

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Obtain all necessary regulatory, ethics, privacy, 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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  • TCPS2 Course on Research Ethics required for all human participant research
  • CANTRAIN clinical trial training modules available at no cost to PHSA-affiliated researchers with dedicated learning pathways based on research role
  • N2 supported CITI platform offers fundamental clinical trial training courses
  • RealTime CTMS supports participant tracking, delegation and document management, study progress, and financial management for clinical trials
  • BCCHR REDCap validated platform for electronic data collection

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Project execution

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


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Project completion

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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Knowledge translation

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. When you're ready to address new challenges, return to the first step of this research process to begin the journey of discovery once again.



SOURCE: Research Process Map ( )
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