Clinical Trial Feasibility Study Questionnaire Analysis.
With the growing complexity and cost of clinical trials (CTs) over the past few decades, Protocol Feasibility (PF) studies have become one of the most critical CT steps in order to avoid costly protocol amendments and ensure the success of CTs. The PF process includes interaction with clinicians located at targeted clinical sites, which results in slow and cumbersome process steps. These process steps are normally supported by information systems that allow users to create, share and collect responses to feasibility questionnaires. This investigation analyzes the systems and questionnaires utilized at several clinical research companies for PF. In addition, it provides recommendations that could eventually improve current methods and systems in place.
Institute of Medical Informatics, University of Münster, Germany.
Iñaki
I
Soto-Rey
Institute of Medical Informatics, University of Münster, Germany.
Martin
M
Dugas
Institute of Medical Informatics, University of Münster, Germany.
Fleur
F
Fritz
D057189:Checklist / Q000592:standards; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D005240:Feasibility Studies; D019983:Guideline Adherence / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011795:Surveys and Questionnaires / Q000592:standards*