Biomedical subjects

A Merzweiler

Publications and source records attributed to A Merzweiler.

5 recordsLinked to original sources

PubMed2005

TERMTrial--terminology-based documentation systems for cooperative clinical trials.

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.

Clinical Trials as Topic↗

PubMed2001

Object-oriented business process analysis of the cooperative soft tissue sarcoma trial of the german society for paediatric oncology and haematology (GPOH).

The German Society for Paediatric Oncology and Haematology (GPOH) runs nation-wide multicentre clinical trials to improve the treatment of children suffering from malignant diseases. We want to provide methods and tools to support the centres of these trials in developing trial specific modules for the computer-based DOcumentation System for Paediatric Oncology (DOSPO). For this we carried out an object-oriented business process analysis for the Cooperative Soft Tissue Sarcoma Trial at the Olgahospital Stuttgart for Child and Adolescent Medicine. The result is a comprehensive business process model consisting of UML-diagrams and use case specifications. We recommend the object-oriented business process analysis as a method for the definition of requirements in information processing projects in the field of clinical trials in general. For this our model can serve as basis because it slightly can be adjusted to each type of clinical trial.

Clinical Trials as Topic↗

PubMed2001

Recording clinical data--from a general set of record items to case report forms (CRF) for clinics.

Standardising a documentary language makes only sense if we use it for documentation consequently. Using an example of Paediatric Oncology in Germany we have developed a procedure that generates CRFs from a documentary language. The introduced procedure has proved to be feasible in practice. With it we can support developers of documentation systems in creating their CRFs; through the guaranteed use of the documentation terminology we further achieve that information recorded with the created CRFs may be statistically analysed across different institutions.

Clinical Trials as Topic↗

PubMed2000

Requirements and design aspects of a data model for a data dictionary in paediatric oncology.

German children suffering from cancer are mostly treated within the framework of multicentre clinical trials. An important task of conducting these trials is an extensive information and knowledge exchange, which has to be based on a standardised documentation. To support this effort, it is the aim of a nationwide project to define a standardised terminology that should be used by clinical trials for therapy documentation. In order to support terminology maintenance we are currently developing a data dictionary. In this paper we describe requirements and design aspects of the data model used for the data dictionary as first results of our research. We compare it with other terminology systems.

Child↗

PubMedDate not supplied

[Standardizing terminology in pediatric oncology--the basic data set].

BACKGROUND: In the context of more than 20 therapy optimizing clinical trials in pediatric oncology an extensive documentation with a big number of case report forms was developed in the last 20 to 25 years. Across these trials same information is partially captured in different terminological ways, by which documentation about patients in the clinics is made more difficult. METHOD: Terminology of therapy optimizing clinical trials of German Society for Pediatric Oncology and Hematology (GPOH) is standardized by a central "standards committee". RESULT: As a first result the basic data set of GPOH could be revised and made available in internet via http://www.dospo.uni-hd.de. CONCLUSION: A basis of a unique documentation language in pediatric oncology is available for German speaking regions.

Child↗