European Clinical Research Infrastructure Network ECRIN

1. European Clinical Research Infrastructure NetworkECRIN Pierre Lafolie, Karolinska Trial Alliance

2. Overview RKP 2004-2006 (Reciprocal Knowledge Programme) TWG 2006-2008 (Transnational Working Groups) PPI 2008-2011 (Preparatory Phase for the Infrastructure)

3. RKP 2004-2006 • FP6 • Gap analysis • Comparative analysis on bottlenecks in clinical research following implementation of CT DIR 2001:20

4. Participating countries • Denmark • France • Germany • Italy • Spain • Sweden

5. Output Report to the Commission on national differences on: 1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, GCP, insurance 5 - Adverse event reporting, drug dispensing 6 - Methodology, data management, data monitoring 7 - Quality management, SOPs, audits 8 - Communication, partnerships 9 - Study registers 10 - Education and careers

6. TWG 2006-2008 • FP6 • Description of tools to overcome gap • Working parties accorded to needs described in RKP • Deliverable to the Commission until September 2008

7. TWG, Aim Provide integrated, ‘one-stop shop’services to investigators and sponsors in multinational studies and facilitate interaction with ethics committees and competent authority, vigilance, monitoring and data management in pan-European studies.

8. Participating Countries • Austria • Denmark • Finland • Germany • Hungary • Ireland • Italy • Spain • Sweden • Switzerland • UK

9. Partners to TWG • European Forum for Good Clinical Practice (EFGCP), Belgium • Europea, Belgium • Telematikplattform, Germany • Ministère de la Recherche, France • Ministère de la Santé, France • Agency for Science, Technology and Innovation, Denmark • Science Foundation of Ireland • Department of Health, UK • Ministry of social affairs and health, Finland • Bundesministerium für Wissenschaft und Forschung, Austria • Vinnova, Sweden • Ministerio de Educacion y Ciencia, Spain • Federal Science Policy Office, Belgium • TEKES, Finland • EORTC (European Organisation for Research and Treatment of Cancer)

10. National Research Networks • Medical University of Vienna (ATCRIN) • Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Rigsharpitalet, Copenhagen University Hospital, (DCRIN) • Kuopio Innovation OY (KUoINNO) • Institut National de la Santé de la Recherche Médicale (Inserm) • Netzwerk der Koordinierungszentren für Klinische Studien (KKS) • Bundesministerium für Bildung and Forschung (BMBF) • Ministry of Health Social And Family Affairs, Hungarian ECRIN Committee, Medical research council (HECRIN) • Dublin Molecular Medicine Centre (ICRIN) • Health Research Board (HRB) • Consorzio Italiano per la Ricerca in Medicina (CIRM) • Istituto di Ricerche Farmacologiche Mario Negri (IRFMN) • Instituto Superiore di Sanita (ISS) • Hospital Clinic I Provincial (SCReN) • Spanish Medicines Agency and Medical Devices (AEMPS) • Instituto de Salud Carlos III (ISCIII) • Karolinska University Hospital (Swecrin) • Universitat Bern (UBERN) • University of Leeds (UKCRN) • Medical Research Council (MRC)

11. Working party 1 on EthicsChairs Xavier Carné, Frank Wells • National differences in the assessment of clinical research protocols by ethics committees • SOPs on: - Informed consent sheet - Interaction with the ethics committees - Personal data protection

12. Working party 2 on RegulationChairs Christian Gluud, Jacques Demotes • National differences in the regulatory framework of clinical research, for all categories of clinical research • SOPs on: - Interaction with the competent authorities - Archiving - Insurance - Management of IMP - Collection, circulation and storage of blood and tissue samples (in collaboration with the EU biobanks infrastructure, BBMRI).

13. Working party 3 on VigilanceChair Nicola Fabris • National differences in the adverse event reporting system for clinical trials on medicinal products and for other categories of clinical research • Both pre-registration trials and post-marketing studies • SOP on adverse event reporting under these various conditions

14. Working party 4 on Data ManagementChair Christian Ohmann • Survey on existing resources for data management in the public research centres within the network • Documents defining specifications for ECRIN data centres providing high-quality data management for multinational studies

15. Working party 5 on MonitoringChair Geneviève Chêne • Risk assessment tool for multinational clinical studies • SOPs on: - Risk assessment - Study monitoring

16. Working party 6 on Quality AssuranceChair Jacques Demotes • SOP on: - Development, approval, review of SOPs and SOP management to be used by the other WPs - Responsibilities within ECRIN and on task delegation contracts between sponsors and ECRIN in the support to multinational clinical research projects • Reviews the SOP drafts produced by the other WPs, ensuring both consistency and comprehensiveness of the set of SOPs

17. Working party 8 on EducationChair Pierre Lafolie Teaching programme on the conduct of multinational clinical research for the ECRIN staff, targeting first the European correspondents through a train-the-trainer session during the summer school, then the staff of the national networks

18. PPI 2008-2011 • FP7 • Implementation of tools developed during TWG • ECRIN network will change into a sustainable European institution, with a legal status of pan-European infrastructure.

19. PPI – Organisation WP1 Management WP2 Legal status and Governance WP3 Financial plan WP4 GMP facilities for Biotherapy WP5 Education and Training WP6 Extension of ECRIN WP7 Capacity building WP8 Quality Assurance WP9 Communication WP10 Data Centres WP11 Pilot project