Technical and legal requirements for data management in collaborative research projects: an example based on the IMI OncoTrack consortium

Data management, data processing and archiving in large collaborative projects generate their own unique technological and legal challenges. Based on experience gathered in the OncoTrack and eTRIKS consortia, both supported by the Innovative Medicines Initiative (IMI), we shall present an overview of project requirements and share experience in the process of providing the necessary legal framework.OncoTrack is an international consortium of 22 partners including academia, pharma industry and SMEs. The consortium is collecting extensive data from colon cancer to aid in biomarker discovery and is using the data to refine in silico methods for prediction of tumour response to therapy. eTRIKS is developing a European translational research framework to support management and analysis of electronic data generated by IMI and other biomedical research initiatives. The consortium is engaged in the development of a platform whose core is the tranSMART open-source software. This is combined with a portfolio of services for data staging, exploration and analysis appropriate for translational research. Data warehousing, data processing and archiving data for re-use and sustainability are processes linked to distinct phases in the lifetime of a project. In the OncoTrack consortium, warehousing and a considerable part of data processing are managed by the partners under the terms of the consortial Project Agreement and the Grant Agreement with the IMI. In order to make full use of the services of eTRIKS, however, a legal agreement was needed. Large collaborative projects are usually not legal entities - contracts must be concluded among all Partners involved. The solution found for the OncoTrack-eTRIKS collaboration was a Data Processing Agreement, allowing us to reduce the number of signatories, while ensuring a framework for technical support and guarantees of data security and privacy required by EU legislation.Archiving of data after completion of a project is essential to ensure sustainability of scientific progress and controlled re-use of the data. The process now underway for OncoTrack, including discussion of the technical and legal hurdles inherent in the undertaking, which envisages a solution using facilities available at the European Genome-Phenome Archive, eTRIKS and ELIXIR, will be described