title: Web-based multi-site feasibility questionnaire tool.
abstract: The design of clinical trial (CT) study protocols, currently supported by clinicians, is often a slow and cumbersome process. The Electronic Health Records for Clinical Research (EHR4CR) project supports the design of study protocols through a multi-site patient count cohort system. However, there is still a need to improve the process step in which the clinicians are involved. This research aims to enhance the EHR4CR platform with a tool to support the contact of CT sponsors with clinical investigators to obtain their input regarding feasibility data for the CT protocol design. From a list of requirements, a technical architecture that responds to the needs of feasibility assessments was modelled. With this architecture as a basis, a system that allows users to generate, send, fill out and visualise results of feasibility questionnaires across clinical sites was developed and integrated within the EHR4CR platform. The resulting system improves the current methods by providing direct contact to clinical investigators, facilitating the creation and answer of feasibility questionnaires for CTs.
authors.affiliation: Institute of Medical Informatics, University of Münster, Germany.
authors.forename: Iñaki
authors.initials: I
authors.lastname: Soto-Rey
authors.affiliation: Institute of Medical Informatics, University of Münster, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Trinczek
authors.affiliation: School of Computer Engineering, University of Valladolid, Spain.
authors.forename: Jose Ignacio
authors.initials: JI
authors.lastname: Amo
authors.affiliation: School of Computer Engineering, University of Valladolid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Bauselas
authors.affiliation: Institute of Medical Informatics, University of Münster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
authors.affiliation: Institute of Medical Informatics, University of Münster, Germany.
authors.forename: Fleur
authors.initials: F
authors.lastname: Fritz
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D015331:Cohort Studies; D057286:Electronic Health Records / Q000458:organization & administration*; D005060:Europe; D005240:Feasibility Studies; D016247:Information Storage and Retrieval / Q000379:methods*; D020407:Internet / Q000458:organization & administration*; D012984:Software; D011795:Surveys and Questionnaires