Journal of Clinical Trials
Open Access

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Publications

• Research   
  An All-in-One Convenient Patient Safety Outcome Assessment Tool Improves Study Patient Reported Outcome Compliance through Real time Data Collection
  Author(s): Nicole C. Hank*, Laura Christians and Brandon McCravey
  
  Background: Subject diaries are utilized in approximately 25% of all clinical trials and are an essential component for gathering patient reported outcomes. Depending on the study design, various methods are utilized to capture patient reported outcomes either through paper, electronic means, or handheld devices. Regardless of how data is being collected, study participants can easily become overwhelmed with the complexity and tedium of recording daily outcomes, which subsequently can lead to inefficient, non- compliant reporting. Even though Adverse Event (AE) reporting and changes in concomitant medication collection are vital in validating the safety and efficacy of an investigational product, the gold standard for collecting real time data is still lacking. Therefore, a standard, all-encompassing, simple patient safety outcome tool is warranted in clinical trials... View More»
  DOI: 10.35248/2471-9870.14.12.514

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