title: TERMTrial--terminology-based documentation systems for cooperative clinical trials.
abstract: Within cooperative groups of multi-center clinical trials a standardized documentation is a prerequisite for communication and sharing of data. Standardizing documentation systems means standardizing the underlying terminology. The management and consistent application of terminology systems is a difficult and fault-prone task, which should be supported by appropriate software tools. Today, documentation systems for clinical trials are often implemented as so-called Remote-Data-Entry-Systems (RDE-systems). Although there are many commercial systems, which support the development of RDE-systems there is none offering a comprehensive terminological support. Therefore, we developed the software system TERMTrial which consists of a component for the definition and management of terminology systems for cooperative groups of clinical trials and two components for the terminology-based automatic generation of trial databases and terminology-based interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.
authors.affiliation: University of Heidelberg, Institute for Medical Biometry and Informatics, Department of Medical Informatics, Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Merzweiler
authors.forename: R
authors.initials: R
authors.lastname: Weber
authors.forename: S
authors.initials: S
authors.lastname: Garde
authors.forename: R
authors.initials: R
authors.lastname: Haux
authors.forename: P
authors.initials: P
authors.lastname: Knaup-Gregori
mesh_terms: D002986:Clinical Trials as Topic; D004282:Documentation / Q000592:standards*; D005858:Germany; D008490:Medical Informatics / Q000458:organization & administration* / Q000592:standards; D015337:Multicenter Studies as Topic; D012984:Software; D009626:Terminology as Topic