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.

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​​​​​​​​​​​​​1.  Project Development

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​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.

For clinical trials, develop a risk assessment and management plan, along with a monitoring plan, to support quality oversight, regulatory alignment, and informed budgeting for trial conduct.

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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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 2.  Project Set-up

Develop study documents

Obtain approvals

Prepare for study initiation

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

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  • 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, electronic source data collection, study progress monitoring, and financial management for comprehensive clinical research portfolio oversight

  • BCCHR REDCap is a validated platform for electronic data collection with randomization module, supporting everything from simple questionnaire studies to complex multi-site investigator-initiated trials

  • Want to understand the difference between RealTime CTMS and REDCap including ​when to use each platform for your study? RealTime vs. REDCap​ 

  • Clinical Trials Registration provides the information and contacts you need to register your clinical study on ClinicalTrials.gov, including help setting up an account

  • In the event ClinicalTrials.gov is unavailable, alternative clinical trial registration options are outlined in CIHR's clinical trials registration and disclosure​ page​

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Set up finance accounts

To receive funding or pay expenses for your project, you'll need an account with either PHSA or your affiliated university, depending on the designated payee in your negotiated clinical trial or research agreement. PHSA utilizes the PeopleSoft system, which requires you to select the appropriate fund type (Fund 01, 06, 07, or 08) based on the specific needs of your project.

Regardless of whether your accounts are managed by your university of PHSA, each agreement must be linked to your unique Funding Application Summary number (FAS#) from the RISe system. This number is generated during your ethics application and used throughout the lifecycle of your project. 

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  • PHSA Research Financial Administration​ outlines how to set up and manage research funding, including where different types of grants can be held and how overheads are applied across PHSA and partner institutions​

  • PHSA Restricted Fund Policy​ provides g​uidance on setting up ​and administering project accounts for restricted purposes including​ research and clinical trials​​​​

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3.  ​Pro​​ject 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 regulatory and ethical compliance by addressing safety and quality issues, maintaing REB application status through amendments and renewals, 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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4.  Project Completion

 

Close the study by completing final monitoring, resolving queries, verifying data, submitting REB study closure notice, and notifying regulatory authorities.

Notify all service providers (e.g. pharmacy, lab, imaging) that the study is closed so they can update their records and know their tasks are complete. Consider highlighting how their work advanced health knowledge to foster a positive research culture.

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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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5.  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.