Introduction
The data management department of the Julius Center provides professional expertise to facilitate the collection, processing, management and analysis of clinical research data. The services of the department are available for a broad range of clients: the Julius Center researchers and Trial Unit, researchers of other UMC Utrecht divisions and external parties.

Expertise
Project management and information analysis
We perform the project management of the data management part of clinical trials and other clinical research projects with a substantial data management component. The first step in data management projects involves the information analysis. In close consultation with the investigator the study specific requirements for data collection and data delivery are determined.

Data management for paper based clinical trials
Using Teleform®, scanable Case Report Forms are developed that allow semi-automatic processing. Collected data will be saved in a secure environment.

Data management for web based clinical trials
The department offers tailored solutions for investigator initiated research projects as well as pharmaceutical industry sponsored clinical trials.
• The web based electronic data capture system Research Online, was developed by the department for investigator initiated research. Its role based platform offers each study its own dedicated and secure website. This website is tailored to the study specific workflow which enables easy questionnaire management for both research staff and study participants.
• The established EDC system Inform^TM (Phase Forward) is applied for pharmaceutical industry sponsored clinical trials.

Randomization of study participants
A flexible web based randomization system is available to perform block and minimization method based randomizations. The system has been successfully used in numerous studies.

Applications for study support
The department has developed several tools to facilitate investigators during research:
• Participant management system. The system can be configured to support the common daily study logistics and administration process.
• Medication registration system. This web based system enables uniform registration of medication in studies.
• Study specific applications and websites. A variety of applications have been developed to support specific study requirements.

Progress reporting and information provision
During the conduct of the trial, detailed study progress and information reports can be provided to facilitate the project management of the study.

Extensive SAS and SPSS experience
SAS and SPSS are used for complicated data processing steps (merging, aggregating, transposing, calculations, labeling etc.), delivering of data sets suitable for statistical analysis in any desirable format and statistical
analysis.

Data warehousing
The department has extensive experience in managing large data sets and processing of routine health care data.

Quality
Data management of all studies is performed according to GCP regulations and when required we also comply with FDA regulation 21 CFR Part 11. The department is using a Quality Management System and was certified according to ISO 9001 in 2005. Data management is routinely subject to internal and external audits and always complies with the expectations.

Experience
Data management has a history of over 10 years and is currently involved in about 100 studies. Among these projects are clinical trials, observational studies, cohorts and management information applications. The department is responsible for the IT-infrastructure and data management of European projects funded by the EC: GRACE and MOSAR. Several large cohorts containing tens of thousands of patients are being managed: Utrecht Health Project, GP Network Utrecht, Psychiatric Casus Register, Biobank etc. Data management participates in large scale innovative projects of CTMM and TIPharma. The department conducts data management of global pharmaceutical industry sponsored clinical trials.

Team
Our staff (approximately 20 people in total) consists of the manager data management, senior data managers, data managers and assistant data managers.

Collaboration
In 2008 Julius Clinical Research (JCR) was established by UMC Utrecht and the Julius Center. This academic CRO facilitates the management and execution of large (multi)national clinical trials. Data management of studies conducted by JCR is being performed by the JC data management department. Data management for global pharmaceutical industry sponsored clinical trials is conducted in collaboration with George Clinical of the George Institute in Sydney.

Contact: Frank Leus