Data Center

The data center supports clinical trials in the planning, implementation and evaluation. The Core Unit therefore develops the necessary infrastructure and databases.

Core Unit Data Center
Photo: istock

Institute for Medical Informatics, Statistics and Epidemiology (IMISE)
Centre for Clinical Trials (KKS)
Duration: 01.05.2010 - 30.04.2015

Function:

  • Coordination of realization and analysis of clinical studies
  • Support and advice for the solution of mathematic/ statistic problems as well as for the shaping of biological processes
  • Establishment of a necessary infrastructure for a central research data base of adiposity

The data centre is available to all projects of the IFB AdiposityDiseases. We offer both an entire supervision of the study and partial supply like the organization of a study data base or the realization of biometric planning and analysis. As a matter of course, a GCP-compliant study conduct is ensured.

The Core Unit is located at the Centre for Clinical Trials Leipzig - KKS and is connected to the Institute for Medical Informatics  , Statistics and Epidemiology. In this way it is ensured that the existing expertise and infrastructure for the IFB AdiposityDiseases can be used in an optimal way.

Business Activities Clinical Trials

Project Management

  • Preparation of study documents (protocol, patient information and consent, CRF, Trial Master File), submission of documents to Ethics Commission and authorities, planning of logistics processes, possibly annual safety reports, if necessary, final reports for EK and authority necessary cancellation of the study at EK and authorities

Biometry

  • Study design, sample size calculation, definition of endpoints, statistical monitoring, preparation of the stat. Analysis plan, if necessary, safety analysis, statistical evaluation, evaluation report, any interim evaluation, contributing to the publication of the results

Data Management

  • Implementation and print of the CRF, provision of study materials like Trial Investigator File (TIF), Working Instructions / SOPs, registration / randomization of patients, possibly data entry, query management, reminder of outstanding documentation

Databases

  • Providing randomization tools, creation and validation of study databases including DB support, remote data entry / internet-based data collection (including training of the academic staff), automatic plausibility and consistency checks 

Clinical Monitoring

  • Initiation of trial centers, ongoing monitoring site

Safety Management

  • Collection, coding and reporting of serious adverse events (SAE), preparation of annual Sic

In folgenden Projekten des IFB AdipositasErkrankungen ist die Core Unit derzeit beteiligt:

  • ADIPO-Vent-trial (Prof. Hermann Wrigge)
  • BARO-Diet-trial (PD Dr. Arne Dietrich)
  • Bariatric index  (Dr. Tatjana Schütz)
  • BAR-SUIZ-trial (Dr. Birgit Wagner)
  • BED-trial (Dr. Birgit Wagner)
  • BEDA-trial (Prof. Anja Hilbert)
  • Adipose tissue development (Prof. Antje Körner)
  • GluMBSE-trial (PD Dr. Arne Dietrich)
  • IFB-PET-trial (Prof. Swen Hesse)
  • Microdialyse-trial (Prof. Hermann Wrigge)
  • PRAC-index trial (Prof. Anja Hilbert)
  • STEN-trial (Prof. Matthias Blüher)
  • TAFF-trial (Dr. Susan Blüher)

Contact:
Dr. rer. nat. Christiane Prettin

tel.: +49 341 97 16273
fax: +49 341 97 16189
e-mail: christiane [dot] prettin [at] zks [dot] uni-leipzig [dot] de

Mathematic modelling

We advice all IFB co-operation partners in mathematical problems/ modelling

  • Application of complex statistical methods for the analysis of genetic data
  • Phenomenological modelling of physiological processes
  • Mathematical models of fundamental processes at the molecular or cellular level

For these issues, we are working closely with colleagues from the Institute for Medical Informatics  (IMISE) and the Interdisciplinary Center for Bioinformatics (IZBI).

Contact:
Dr. rer. nat. habil. David Petroff
tel.: +49 341 97 16354
fax: +49 341 97 16189
e-mail: david [dot] petroff [at] zks [dot] uni-leipzig [dot] de

Central Research Database

This project forms the IT-bridge between  patient care and clinical research in the IFB AdiposityDiseases. From there an infrastructure for a central research database for obesity evolves.

  • ensures a long-term, secure data storage
  • allows an integrative organizational and technical method
  • is a hub for the exchange of data between the faculty and the hospital projects and allows on the basis of already collected data
  • the processing of requests feasibility (feasibility) of clinical trials
  • the generation of hypotheses for new research projects

This requires a structured documentation of obesity at the University Hospital Leipzig (UKL). Appropriate anamnesis forms in the SAP have been and are provided here. This process is compliant with the data privacy act and ensures secure administration of data in the research database on time. The central identity and data management allows to merge data from different sources compliant to data protection and indepent from patients and is inter-coordinated with tthe Leipzig Research Centre for Civilization Diseases (LIFE).   The close cooperation also eases clinical researchers a secure access to the research data.

The data centre

  • supports the import and transfer of data
  • arranges and advises on data protection issues (anonymity / pseudonyms, registration of volunteers
  • provides methods and tools for data export and exploration 
  • implements methods and processes to support trials  at the UKL, e.g. to label study patients  

Co-applicant of the project are both the Center for Clinical Trials Leipzig (TCS), the Interdisciplinary Center for Bioinformatics (IZBI) as well as the IMISE project group 'management of health information systems (MIG)' in cooperation with the IFB's office and the information management of the UKL.

Contact:
Dr. rer. med. Frank Meineke

tel.: +49 341 97 16111
fax: +49 341 97 16109
e-mail: frank [dot] meineke [at] imise [dot] uni-leipzig [dot] de