Workpackage 5: Data management, monitoring and statistics
Objectives and Tasks of the Workpackage
The WP is led by the head of the Institute of Medical Biometry and Informatics of the University of Heidelberg, Prof. PhD Meinhard Kieser.
The global objective of data management is to ensure timely delivery of high-quality data in order to satisfy both Good Clinical Practice (GCP) requirements as well as the requisites of an adequate statistical analysis and reporting. It comprises all steps of data handling such as acquisition, processing and utilization of data.
The first and very important step within the project is the implementation of an online data base to collect data for the cross sectional and longitudinal study. It will be implemented as electronic data capture screens in a remote data entry system. In order to guarantee high quality of the data, predefined edit checks will be implemented for data validation.
All data collected will be managed in a safe and secure environment. The system used for data management is validated and is compliant with FDA 21 CFR part 11. The data transmission is encrypted with secure socket layer (SSL) technology and all changes to data are logged with a computerized timestamp in an audit trail. To round up the safety of the data, the database server with the stored data is located in a secure data centre and is protected by a firewall.
To ensure patients safety and integrity of the clinical data, monitoring will be performed by at least one personal on-site, according to the ICH-GCP guideline (E6) and approved standard operating procedures. Particularly the study will be conducted in accordance with the Declaration of Helsinki and the requirements of all applicable local and international standards, e.g. data protection law. Written informed consent of all patients will be obtained prior to data collection.
The statistical support will include adequate statistical planning and analysis of the psychotherapy- RCT. Another main task of the WP is the adequate modelling of the cross sectional and longitudinal data. During the whole project period, statistical advice and support will be given to all applicant partners.