ECRIN-PPI European Clinical Research Infrastructures Network and biotherapy facilities Preparation Phase for the Infrastructure Pegah Souri Europeisk Korrespondent

Organisation ECRIN 2 TWG Arbetsgrupper WP1 Ethics (Carl-Olav Stiller) WP2 Regulation (Charlotte Asker-Hagelberg) WP3 Vigilance (Carina Alvfors) WP4 Data Management (Mats Hellström) WP5 Monitoring (Solveig Wennerholm) WP6 Quality Assurance (Clementine Molin) WP7 Extension of ECRIN WP8 Education (Pierre Lafolie, ordförande)

Deliverable No Deliverable titleDelivery date LeaderReleased 15Specification for quality assurance requirements6WP6Y 9Survey on data management tools9WP4Y 12Survey on existing strategies for monitoring and risk definition 12WP5 10Specification for CGP-compliant data management in international trials 15WP4 16Set of generic EU SOPs and implementation guidance18WP6 24Survey on existing education programmes18WP8 1Guidelines on ethical review and informed consent21WP1 2Guidelines on how to interact with ethics committees21WP1 13Definition of a common set of criteria for risk evaluation, and of common monitoring strategies 21WP5

Deliverable No Deliverable titleDelivery date Leader Released 3Publication on ethics and informed consent24WP1 4Report on guidelines for regulatory affairs24WP2 5Meeting with EMEA on regulation and vigilance24WP Report on survey and guidelines on adverse event reporting (AER) 24WP3 7Network for post-marketing safety report24WP3 8Report on computerization of AER24WP3 11Prioritization and selection of data management tools for multinational trials 24WP4 14Final report-publication on monitoring24WP5 17Final report on quality assurance24WP6

Deliverable No Deliverable titleDelivery date LeaderReleased 18SOPs on ethics committees24WP1 19SOPs on regulatory affairs24WP2 20SOPs on adverse event reporting24WP3 21SOPs on monitoring24WP5 22National reports for new networks connecting to ECRIN 24WP7 23Update of the website24WP7 25Material for national education programmes24WP8 26Material for European education programmes24WP8 27ECRIN-TWG final report24COORD

Nya arbetsgrupper ECRIN 2 TWG Gamla arbetsgrupper WP1 Ethics WP2 Regulation WP3 Vigilance WP4 Data Management WP5 Monitoring WP6 SOP WP7 Extension of ECRIN WP8 Education ECRIN 3 PPI Nya arbetsgrupper 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

Ny organisation

WP1 Management

WP2 Legal Status

Etablera legal status för att möjliggöra: - Utdrag av kontrakt - Effektiv hantering av finanser - Utbyggnad till andra medlemsländer - Effektivare beslutsfattande

WP3 Financial Plan

Utvärdera kostnader associerade med nätverket Undersöka tillgängligheten av olika former av finansiering inom klinisk forskning - Kapacitetsprogram - Medlemsländer - EU fonder - Industrin - Intern Kostnader associerade med Capacity Building, GMP facilities och Data Centres Verksamhetskostnader, på nationell och europeisk nivå, management och QA

ECRIN-PPI European Clinical Research Infrastructures Network and biotherapy facilities Preparation Phase for the Infrastructure Pegah Souri Europeisk Korrespondent

WP5 Education

TWG Education Deliverable 24 Survey on Existing Education Programmes Deliverable 25 Material for National Education Programmes Deliverable 26 Material for European Education Programmes

PPI Education TWG Deliverable 24 Survey on Existing Education Programmes PPI Webbaserad och kontinuerligt öppen databas. Information om kurser tillgängliga på nationell nivå.

PPI Education TWG Deliverable 25 Material for National Education Programmes Deliverable 26 Material for European Education Programmes PPI 1. Intern utbildning av Europeisk korrespondenter 2. Utveckling av E-learning verktyg 3. Utbildning av personer inom de nationella enheterna vad gäller genomförandet av multinationella studier

WP6 Extension

Utbyggnad till andra medlemsländer och EU-baserade infrastrukturer: –Nya medlemsländer (NL, Be, Pl, Gr, Pt, Tr, etc…) –Ny infrastruktur (pediatrik)

WP7 Capacity Building

Bistå i utvecklingen av nationella infrastrukturer och stärka nationella kapaciteter. EC = European Correspondent NNC = National Network Coordination (SE = SWECRIN) GMP = GMP facility for biotherapy DM = Data centre CRC = Clinical research centre

Nationella nätverk 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)

WP7 Quality Assurance TWG WP

TWG Quality Assurance Comparison of national requirements EC CA Sponsor Insurance AER

WP8 Quality Assurance Uppdatering av det redan etablerade QA-systemet Uppdatering av multinationella SOP:ar och riktlinjer, koordinerade med EATRIS och BBMRI Implementering på nationell nivå Audit strategi och utvärdering av kostnader

ECRIN-PPI European Clinical Research Infrastructures Network and biotherapy facilities Preparation Phase for the Infrastructure Pegah Souri Europeisk Korrespondent

WP11 Pilot Project Pan-europeisk klinisk studie

Sammanfattning