Deliverables Documents, reports (18) Level 2 Clinical ICF Migration Level 1 Clinical ICF based on T4.1.1, T4.2.1 and D4.15 Migration Training Materials for patients and to increase awareness about R&D, and to clarify essential aspects of data privacy laws and regulations in R&D Migration Toolkit for the identification, selection, and measurement of outcomes in real world settings for BD4BO projects Migration Narrative: The consortium narrative that communicates the purpose of the BD4BO programme Migration Establish unmet ‘big data’ data needs of the health care system Migration Provide quarterly updates on key learnings from BD4BO projects about outcomes standardisation and methodological issues Migration Level 2 Non-Clinical ICF Migration Level 3 Biobanking ICF Migration Develop a targeted outreach plan for external collaboration with stakeholders Migration Develop interim/short-term strategic guidance document Migration Interim guidance document for existing BD4BO projects on approach proposed by the Distributed Data Network working group Migration Level 3 Non-Clinical ICF Migration Develop the overall BD4BO programme strategy/long-term strategic guidance Migration Level 2 Biobanking ICF Migration Level 3 Clinical ICF Migration Explanatory Information on minimum data privacy standards for ICFs for clinical studies, non-clinical studies and biobanking incl. focus group’ feedback on the Clinical ICF, Non-Clinical ICF and Biobanking ICF Migration Summary of the empirical investigation results, including proposal on method in order to integrate survey results Migration Other (9) Ongoing strategic oversight and guidance Migration Continous exchange with external data privacy related stakeholders (DPECs, BD4BO projects, other related data privacy initiatives) Migration Establish Data Privacy and Ethics Committees (DPECs): - Operational-DPEC (DPEC-O) - Regulatory-DPEC (DPEC-R) Migration Establish and coordinate engagement with International Advisory Board (IAB) and Data Protection & Ethics Committee (DPEC) Migration Host virtual workshops to enable the dissemination of WP2 learnings and outputs Migration Set up the infrastructure and maintenance required for the communications and outreach plans; refer to deliverable descriptions for the type of activities that will be implemented Migration Development of BD4BO online repository Migration Run DPEC-R F2F workshop to collect input on critical data privacy topics Migration DPEC-O F2F workshop to collect input on critical data privacy topics Migration Publications Non-peer reviewed articles (2) Big Data for Better Outcomes: Supporting Health Care System Transformation in Europe Author(s): Miklós Szócska, Sahan Jayawardana, Carin Smand, Tayyab Salimullah, Catherine Reed and Shahid Hanif Published in: EuroHealth, Issue 2017; Vol. 23(1):, 2017, Page(s) 7-9, ISSN 1356-1030 Publisher: London School of Economics and Political Science Connecting the dots: putting big data to work for health systems Author(s): Maximilian Salcher Published in: EuroHealth, Issue 2017; Vol. 23(1):, 2017, Page(s) 3-6, ISSN 1356-1030 Publisher: London School of Economics and Political Science Other (3) Interim guidance document for existing BD4BO projects on approach proposed by the Distributed Data Network working group Author(s): Michel Van Speybroeck (Janssen), Michael Arend (Bayer), Jeremy Hayter (Pfizer), Joachim Marti (Imperial College London), Anthouny Rowe (Janseen), Jerry Lanfear (Pfizer) Published in: 2017 Publisher: BD4BO Programme Interim strategic guidance document Author(s): Myriam Drysdale, Marianne Cunningham and Bart Barefoot(GlaxoSmithKline); Fredrik Moen from the Swedish Institute of Health; Tino Melzer (Bayer); Irene Schluender (TMF);Michel Van Speybroeck (Janssen); Michael Arend (Bayer); Jeremy Hayter (Pfizer); Joachim Marti (Imperial College London); Anthony Rowe (Janssen);Jerry Lanfear (Pfizer);Carmen Fenollosa (LSE);László Bencze (Semmelweis University) Published in: 2017 Publisher: BD4BO Programme CliniCal Core outComes sets in real World data Author(s): Ciani O1, Meregaglia M2, Jayawardana S3, Carney C3, Salcher M3, Williamson P41Centre for Research on Health and Social Care Management (CERGAS), Bocconi University, Milan, Italy, 2Bocconi University, Milan, Italy, 3London School of Economics and Political Science, London, UK, 4University of Liverpool, Liverpool, UK Published in: VALUE IN HEALTH Journal, 2018, Page(s) 112 Publisher: https://www.valueinhealthjournal.com/ Searching for OpenAIRE data... There was an error trying to search data from OpenAIRE No results available
