Roadmap Instructions

Welcome to the Clinical Research Road Map. Use this guide to verify the proper steps to develop and plan your research in Alberta. Use the four sections to identify your current phase of research. Use the toggles on the right of each step to expand and learn more.

Use the expand all toggle to open all steps on your current phase.

Steps with a hollow border can be completed concurrently with other hollow border steps.

Roadmap Instructions Research Toolbox

CONCEPT

The study is in the ‘concept’ or ‘idea’ stage. The goal is to identify a focused, answerable question that addresses a gap, contributes to the body of knowledge, enhances health services and/or delivery, and improves patient care or outcomes.
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    Question

    What is the research question?

    A good research question should be of interest in the scientific community and/or the public, have clinical relevance, further current knowledge in the field compliant with local ethical standards, and should specify the population of interest. 

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    Data and Measurement

    What will the study measure/capture? 

    Data variables are the counts, observations and measurements that can differ from individual to individual over time.  Levels of measurement (data types) of the data collected over the length of a study determines the type of statistical analysis that will be required for the data. 

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    Engagement

    Who will be impacted by the results of the study?

    When individuals who will be affected by or interested in a project are engaged early on in the planning stages of a project, the resulting study can be more meaningful or impactful.  

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DEVELOPMENT

Designing the study and identifying the research team. Once the research question has been formulated, the development stage involves identifying the target study or data population; where the research will be conducted, what is collected and how; research method and analysis; and who is involved and/or the expertise to be consulted.
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    Study Design

    How will your study be carried out?

    A research protocol is the document that describes in details the plan for your study including the objectives, study design, methodology, analysis and resources. Making sure the protocol is developed to the fullest and contains the key elements promotes high quality research and eases obtaining regulatory approvals. 

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    Data Sources, Collection and Methods

    What is your plan for the study data?

    Identifying the source and availability of data as well as how the data will be collected, stored and analyzed, and the inherent limitations therein will help to ease study start-up. 

     

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    Ethics Requirements

    What are the ethical considerations of your study?

    The type of research project proposed will determine the ethical requirements of the study. Clinical health research studies require institutional research ethics board (REB) approval. 

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  4. 4

    Informed Consent

    The informed consent process is one of the most important elements of clinical research. Properly written Informed Consent Forms (ICFs) should be considered early in study development and can help your ethics review process go more smoothly.

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    Study Materials

    What documents, forms, spreadsheets, or other materials will be required to carry out the study?

    The forms associated with the study should be developed to fit the research questions and methodology.

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FEASIBILITY

The research, project protocol, or proposal is close to final and in this stage, it is assessed whether the necessary resources including access to patients/data and other resources, are in place to successfully conduct the study/project.
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    Resources

    How is your study being supported?

    Identifying whether sufficient funds and resources can be secured helps to assess whether a study is feasible. 

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    Access

    What resources will you need access to for your study?

    Reviewing the requirements of a study as relates to access to target study populations, data, equipment and clinic space can help to assess whether a study is feasible. 

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    Study Review

    Has the study been reviewed by the qualified individuals and the applicable departments?

    Reviewing the scientific and operational requirements of a study can help to address whether a study is feasible.

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PROJECT IN SET-UP

Once the protocol has been detailed and finalized, there are a number of approvals to help ensure participant protection, privacy and confidentiality, as well as, ethical and organizational oversight. Many of these steps proceed concurrently.
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    Approvals

    Does your study involve human participants and/or their health information?

    Will your study impact hospital departments, pharmacy, lab or other areas?

    Does your study involve a drug, medical device or natural health product?

    Several approvals are required in order to get your study started. These include ethics approvals, operational approvals, regulatory approvals and administrative approvals.

     

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    Research Agreements

    Does your study involve accessing health information?

    Several types of Research Agreements may be required for your study.

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    Contracts

    Does your study have documents and legal agreements that must be reviewed by the applicable legal department?

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  4. 4

    Accounts

    Who is responsible for setting up the accounts for your study?

    Your study may require an account to be set up. 

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  5. 5

    Trial Registration

    Are you required to register your trial?

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    Training

    Do you require study-specific training  for study staff? 

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ACTIVE STUDY

Once all of the necessary approvals have been obtained, the study or project can begin (i.e. open to recruiting participants, obtaining charts or data for review). Throughout the study, annual ethics approvals; protocol and/or contract amendments; monitoring, etc. may be required. Note: during this stage, the study may progress to the stage of closed to enrolling additional participants, but still be active for data analysis or queries.
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    Reporting

    What reporting will be required for your study?

    Annual scientific progress reports are often requested as part of funded research grants or awards and may be required for each year the fund is awarded following by a final report after the end of the study.

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    Monitoring

    What monitoring is required for your study?

    During the course of the study it is important to monitor the progress regularly to ensure it is run in compliance with regulations, the protocol, the contracts and agreements, the budget and can be completed with the allotted resources and finances. 

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    Amendments

    Do you need to make an amendment to your study protocol or contracts?

    During the course of the study, due to unforeseen circumstances, it may difficult to adhere to the study protocol as written and become necessary to make changes to the study protocol and/or the informed consent forms. Alternatively,  the funder or sponsor may require notification of project changes as part of a contract amendment.  

     

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CLOSED

All study-related activity is completed. Applicable parties who have been involved in the study are informed. (i.e. research ethics board, research office, finance, purchased services, sponsor). At this point, research materials are gathered, and samples or data is shipped, saved, or destroyed.
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    Prepare for Study Closure

    Have you identified all the requirements for closing out your study? 

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    Inform Institution/Regulatory Agencies

    A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. 

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    Inform REB

    Have you notified your research ethics board of the closure of your study?

    The REB must be notified of the closure of a study and be provided with a final report pertaining to the activities of the study. Note:  A study should not be closed until data analysis is complete.

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    Archive Documents

    Do you have a plan for the long-term storage or archiving of your study-related documents?

    Certain study files and documents must be kept for an extended length of time. You may choose to store these yourself, or they may be stored offsite via an information management service.

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