During the first months of PREPARE, CRISP starts the information analyses process to define the detailed data management requirements for the clinical studies of PREPARE. Based on the specifications obtained during this process the data management plan will be developed which will outline all data management processes to be implemented to ensure the complete, consistent and correct data collection for the clinical studies and to facilitate all other data management issues during the conduct of the studies. The developed data management plan will serve as the basis for all further data management activities of CRISP within PREPARE.