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Clinical Research Study

A clinical research study leverages existing data captured for administrative purposes on a population.  Examples can be found on the website of the Institute of Clinical Evaluative Services (ICES), which houses the administrative databases for the Province of Ontario. Researchers employ epidemiological methods to address questions posed by decision makers, policy makers, health planners, practitioners, or that are of interest to health services researchers.

Research using ICES databases answers questions such as: Is colorectal screening utilized appropriately as an effective strategy for early detection of colorectal cancer? Does the use of drugs, such as COX-2 inhibitors in patients with arthritis, improve outcomes? Are patients who suffered a heart attack getting optimal care?

Experiential visits by KSU Program participants conducting a population based study typically last 6-8 weeks. Since research question identification can take up to 4 weeks to complete, we recommend that participants start identifying their research question before they arrive in Canada.  Instructors will provide support and guidance on how to write a clear and concise research question.  
 
Participants use their time in Canada for protocol development and dataset creation plan development which can take up to 8 weeks to complete.   The remainder of the project including discussion of results, drafting the manuscript, submitting the manuscript to the instructors for approval, and final manuscript submission can be completed from Saudi Arabia in consultation with the instructors.
 
A sample outline and timeline for typical population-based study includes:
 
Weeks 1-4 
Identify a pertinent Research Question that can be answered using the available information
 
Weeks 4-7 
Develop a protocol that is approximately 4-5 pages long including background, rationale, primary objective, methodology, statistical analysis, limitations of the design, and reference list
 
Weeks 8-12
Develop a Dataset Creation Plan (DCP) detailing the analysis plan in order to define the study population, outcomes and respective codes to be used in the data extraction, and medication lists
 
Week 13
Submit documentation to ICES including the Protocol, DCP, Privacy Impact Assessment document, and Project Activation Worksheet
 
Weeks 14-18
Extraction and statistical analysis of data (conducted by ICES)
 
Weeks 19-22
Discussion of results in collaboration with Principal Investigator (PI)
 
Weeks 23-30
Draft manuscript for PI review
 
Weeks 31-37
Revise manuscript based on recommendations and submit to PI for final approval
 
Week 38
Manuscript submission 
 
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