IT Coordination Group and ECRIN Data Centers

Transcription

1 IT Coordination Group and ECRIN Data Centers Venizeleas D, Ohmann Ch April 16, 2007 DRAFT Version April 16,

2 Contents Contents 2 1 Introduction 3 2 IT Platform 3 3 Platform Organization IT coordination group IT Advisory board Working Groups Scientific User Community ECRIN Data Centers 6 5 Resources 6

3 1 Introduction As outlined in the ESFRI Road map (Report 2006) the ECRIN network will set up infrastructures for professional data management in clinical trials. In specialized data centers functionality like Remote Data Entry will be provided with high quality and in accordance to international and EU regulations. As the project should lead to long-term structuring effects the openness to other networks of clinical research will be essential. Additionally to the horizontal linking to clinical research the vertical linking to other phases and activities of basic research has to be considered, to enable an accelerated translation of research outcomes into practice ( bench-bedside-practice ). An integrated approach to manage the complex data management tasks should therefore be followed from the beginning. The conception has to take into consideration the present knowledge of the ECRIN network, e. g. the results of ECRIN wide surveys and results. 2 IT Platform The networks that will be connected within ECRIN will help clinical trials to be conducted more effectively. An important role is that of ECRIN data centers as operational nodes to provide GCP compliant data management facilities. Not only resources will be shared but also the question of data sharing will come up. The information technology platform that has to be build should be scalable to be able to integrate and expand clinical research networks and to be able to link to networks of basic research and also to communities of physicians and patients. Therefore an open approach is needed for allowing access to research data and tools for academia, industry, authorities and communities. This approach includes the interpretation, adoption and implementation of standards (e. g. GCP, CDISC 1, HL7 2, MedDRA 3 ), the definition of frameworks (standards for software development, platforms and protocols like J2EE 4, SOAP 5 etc., semantic interoperability, interfaces, license models etc.) that ensure the integration and development of tools needed for interoperable research activities. The focus however should be set on the specific and effective implementation of tools needed by the network. The deployment of IT-related services and tools should be subjected to a formal Quality Management approach and endorse the harmonization aspect. 1 Clinical Data Interchange Standards Consortium 2 Health Level 7, standard for the interfacing of clinical data in patient care 3 Medical Dictionary for Regulatory Activities 4 JAVA 2 Enterprise Edition 5 Simple Object Access Protocol

4 3 Platform Organization The platform should consist of a scientific advisory board, an IT coordination unit with mediator role, work groups for specific tasks and an informal and open scientific user community. The legal status cannot be specified at this point but has to be discussed within ECRIN during the preparatory phase. 3.1 IT coordination group A core IT coordination group should be responsible for Initiation and Coordination of platform activities Strategic planning of IT activities and infrastructure Coordination and steering of working groups Evaluation and mediation of tools and frameworks for Software evaluation Software development System validation (guidelines for doing this should be developed/identified) Collaboration Implementation of standards (the relevant standards have to be identified and agreed upon) Coordination of software development (the way the platform will support software development has to be agreed upon) Evaluation and recommendation of standards and complying tools Evaluation and accreditation/certification of data centers (the principles of certification have to be worked out in detail) Methodic support of data centers Definitions of practices and guidelines to obtain GCP compliance Establishment of an overall Quality Management system (e. g. auditing and certification of data centers) Training and implementation Regular audits of certified centers to ensure adherence to standards and procedures Cooperation with national or international activities (e. g. cabig, EU projects) for creating greater research synergisms

5 Cooperation with other ESFRI projects (EATRIS, Biobanking) to harmonize and to integrate data management between basic, translational and clinical research through common strategies and coordinated activities (supported by a joint working group of the ESFRI projects ECRIN, EATRIS and Biobanking) Considering the high work load, the IT coordination group could be essentially a formal unit. 3.2 IT Advisory board At national level responsible people with IT expertise should be designated as members of an ECRIN IT scientific advisory board cooperating with the ECRIN network committee in supporting the IT coordination group. 3.3 Working Groups Working groups of IT specialists and data management experts are responsible for specific tasks. These tasks could be identified in a preparatory phase by working out key issues and providing referential documents, e. g. minimal requirements, definition of terms like GCP compliance, checklists etc.. Tasks could be e. g. CRF libraries and standards Semantic interoperability Clinical Trials Data Repository Data sharing, intellectual properties User Requirements Specification System validation, standards and evaluation of specific IT implementations (for central or remote data management) Standard Operating Procedures Activities with similar focus on data management should be identified and taken into consideration in order not to duplicate work already in progress. Existing work should be incorporated and future activities based upon. 3.4 Scientific User Community The scientific community covering all ECRIN networks and individual CTUs (clinical trial units) and CRCs (clinical research centers) participates in an informal manner. The community gives input in respect of User Requirements

6 Software development Evaluation, Validation Implementation and training 4 ECRIN Data Centers ECRIN data centers will be based upon existing resources and competencies available within the ECRIN network. It is planned that existing data centers (alone or as a network) are qualified to become ECRIN data centers providing data management services for multinational trials, additionally to their usual business, e. g. data management in national studies or cooperations with other study groups. The requirements presumed for ECRIN data centers have yet to be detailed. The process of establishment of ECRIN data centers is supported and steered by the IT coordination group. This group defines user requirements, software specifications, quality targets, audit procedures, software evaluation and validation processes, etc. Existing or emerging data centers of ECRIN can apply for becoming an ECRIN data center in accordance with the framework and conditions specified by the IT coordination group. Evaluation is performed by the IT coordination group (e. g. via audit procedures) and can lead to approval and certification with status of an ECRIN data center. The process to qualify for being an ECRIN data center is supported by ECRIN. This may cover costs associated with the qualification procedure (knowledge transfer from the IT coordination group, audits, provision of tools) however not the software costs (licenses, development). Prerequisite for becoming an ECRIN data center is the commitment to support multinational trials according to service conditions specified by ECRIN. In the preparatory phase one prototype data center will be implemented and qualified. 5 Resources IT coordination group: 1 coordinating scientist with strong IT background 1 scientist with major experience in clinical data management 1 system administrator (infrastructure for working groups and scientific community including portals, collaboration platforms, tools etc.) 1/2 secretary Working groups: 3 to 6 person months per partner

7 IT advisory board: 1 meeting per year (reimbursement) Scientific user community: 1 meeting per year (reimbursement for ECRIN partners) Qualification of ECRIN data center: e per center

8 Figure 1: Platform organization IT coordination group and ECRIN data centers ECRIN Data Centers ECRIN Coordination IT Coordination Group IT Advisory Board Working Groups User Requirements Scientific User Community Libraries / Standards Interoperability Validation IT and DM specialists from National networks Individual ECRIN centers