Medical imaging plays an increasingly important role in extracting quantitative measurements for clinical trials. DICOM (Digial Imaging and Communication in Medicine) is used for the exchange of medical images for clinical routine as well as for research purposes. DICOM storage media, often also called patient CD/DVD, is usually used for the exchange of medical images in clinical trials. In a clinical routine, DICOM media is exchanged for patient care. In the area of clinical research, such media is commonly used for the interchange of images between clinical trial sites and the clinical trial coordination center.

In clinical trials, patient information that may lead to  identification needs to be de-identified in order to protect the patient's privacy. However, for those scenarios DICOM already supports a special mechanism that introduces a clinical trial "subject" into the images that replaces the identifying patient data. Nevertheless, depending on the clinical trial, some patient information (e. g. the patient's age) may be retained in the images because it is required to successfully conduct the trial.

The SWABIK project aims at supporting the exchange of DICOM storage media in clinical research. Within this project, best-practice guidelines are developed to support the users  creating and importing such media in the clinical trials context. In addition, standardized software tools are developed for creating and importing such CDs. OFFIS is going to realize software tools to assemble and pseudonymize medical image data for clinical research applications in order to create high quality DICOM media. Furthermore, the developed software will be complemented by tools for quality assurance for checking the quality of DICOM media. The test results are shown in an adequate and comprehensible format that indicates in a simple way the degree of usability the CD offers and its usability for a certain purpose. OFFIS will also work on tools to let receivers safely import medical image media into the local image archive. Therefore the project heavily supports the efficient and effective conduction of studies in the area of clinical research.

This project is funded by the German federal ministry of research and education (BMBF) and supported by two organizations. One of them is the Working Group for Information Technology (AGIT) of the German Society of Radiology (DRG). It focuses on the support, development and dissemination of standards and recommendations for information exchange and workflow in radiology including DICOM and IHE.

The other one is the Coordination Centers for Clinical Trials (KKS Network) which was initiated by the Federal Ministry for Education and Research (BMBF). It forms a platform for transparent, patient-oriented development of new drugs and therapeutic principles. The KKS Network stands for comprehensive advice and support for planning, conducting and evaluating clinical research projects.