WP10 – Research infrastructure for data management (clinical, imaging, biobank)
Moniek de Maat (EMC) & Theo van Walsum (EMC)
The main hypothesis of this WP is that optimal management of the data from the trials and the preclinical studies (A), the imaging (B) and the biobank (C, data and materials) optimizes quality and efficiency of implementation and execution.
A) The first objective is to harmonize and support data collection, data management, state-of-the art methodology and statistical analyses for CONTRAST 2.0. We will modernize our unified data management protocols developed in CONTRAST 1, and our Electronic Data Capture (EDC) system across the entire project. Quality of the data will be enhanced by coordinating independent data monitoring of the RCTs, and monitoring completeness and validity of the data. We will provide WPs with a raw cleaned version of the study data from our EDC system at the end of the study. Standard approaches to methodology, statistical analysis and reporting will be developed and disseminated to CONTRAST 2.0 investigators. Data management (i.e. creating, recording and issuing datasets) for research proposals of both CONTRAST 1.0 and CONTRAST 2.0 trials will be coordinated and provided by WP10 via the online research platform anDREa.
B) The second objective is to build and maintain imaging infrastructure that allows for online image upload and storage, to facilitate qualitative assessment of images by core-lab members, by implementing an online scoring system and to facilitate automated image analyses.
C) The third objective is to maintain a biobank: For the trials where patients are being included, the objective is to biobank biological materials, i.e. blood samples, thrombi and hematomas.