WP08: Data Management

Objectives

The main objective of WP08 will be to establish and maintain a database conforming to GCP-guidelines for the documentation of the clinical trials conducted within the EuroSkinGraft project. The Data Management project team will ensure online data entry, storage and retrieval; and it will provide training and support for the investigators in using the system. At the end of the project all collected data will be centrally stored, validated and made accessible for analysis -meaning less effort for the investigators, the clinical staff and the statisticians.

Workpackage Description

The development and maintenance of the EuroSkinGraft database will include both technical (e.g. programming) and scientific (e.g. automatic plausibility checks of data entry) tasks. In order to meet the requirements of data integrity and security as well as the scientific requirements of the clinical trials, the ukb will closely collaborate with the scientific and clinical partners in the consortium. Five main tasks have been defined:

Task 1: Data management plan The data management plan will define the processes of data collection, storage and accessibility incorporating the technical requirements as well as taking into account the data safety and ethical requirements as defined by the study protocols.

Task 2: Clinical research forms This task will include the definition of required clinical variables, item formulation, design of the digital questionnaires and definition of the plausibility checks in order to program the electronic CRFs.

Task 3: Database set-up and testing The database will be set up and hosted using the modular secuTrial software which is based on an Oracle database. After its initial set-up and completion of the CRFs the whole process of data entry, storage and retrieval will be tested to professional standard.

Task 4: Training and support A first course will train tasks as navigation in the online front end of the database and data entry. During the trials a technical online-helpdesk will provide support for users in using the eCRFs. Constantly answering all questions regarding the data acquisition during the ongoing clinical trials will minimize the entry of invalid or missing data.

Task 5: Data preparation After completion of the trials we will retrieve the raw data of the three trial centres. First a preliminary scan will reveal all missing values. This missing values will be cross-checked and subdivided in true missings (value was and is not measurable) and missings due to human errors. If possible, the latter will be gathered retrospectively in close collaboration with study staff and study monitors and entered into the database. Finally, the complete recorded data will be transferred according to the technical requirements of the statistician conducting the final analysis.