The overall aim of this work package is to provide a central biometrical and data management unit for all ICare collaborators and to maintain comparable high quality in the conduct of the ICare research projects in trial planning, data management, online data quality reviewing, analysis and reporting.
Specific objectives are:
- Providing central biometrical support and data analyses for all RCTs conducted in the ICare project including study planning, the preparation of randomization lists, statistical analysis plans, and statistical reports and analysis of the primary and secondary endpoints of the planned RCTs.
- Defining measures to protect personal data of trial participants/patients.
- Providing central data management support for all datasets collected in RCTs in the ICare projects including the definition of a standardized way to exchange data within the project consortium, and the definition and execution of online data review procedures to identify potential data quality issues and other problems regarding the conduct of the study (e.g., problems in randomization) early.