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Spotlight on Research: Setting Up a Clinical Study: Get Ready, Set, and Go
Teresa J. Kelechi
Bonnie P. Dumas
Moby Madisetti
Bobbie Rinard
Greg Loftis

Journal of Wound, Ostomy and Continence Nursing
December 2012 
Volume 39  Number 6
Pages 591 - 594
  PDF Version Available!

Newly funded investigators eagerly await the exciting moment when they officially start their study but often face the difficult challenge of determining "where" to begin. Do not panic! The purpose of this "Spotlight on Research" column is to walk you through this initial setup process, step by step using examples from our work with a grant awarded through WOCN's Center for Clinical Investigation from Molnlycke Health Care. We evaluated a WOC nurse-directed, patient-centered intervention called MECALF-motivational enhancement (ME) and conditioning activity for leg function (CALF)-in a sample of wound clinical patients with ulcers and pain.Begin your study by reviewing the WOCN Grant Proposal Toolkit, Section III.1 The site offers an outline, flow chart of study activities, and useful checklist. We printed out these documents, especially the checklist, and used them to guide our study activities. The checklist was reviewed at each team meeting and items checked off as our study progressed. See Table 1 for an outline of the steps of the startup process.The principal investigator (PI) in charge of our study contacted all study personnel (WOC study nurses, research nurse, project director, mentor, and statistician listed on the grant) to tell them the good news and to make sure that they were interested and committed to working together. The PI offered some references for study personnel who expressed a desire to brush up on their research knowledge.2 Remember that any member of your team who comes into contact with a study participant, performs an intervention, has access to protected health information (PHI), or collects data from participants will have to complete some type of mandatory human subjects protection training requirement. Check with your institutional review board (IRB) if this training has not already been completed.Next, the project director and the research nurse were hired and oriented by the PI. Their roles and responsibilities were clearly described

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