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.
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.More Details
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.More Details
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.More Details
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.
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.More Details
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.
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.More Details
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.More Details