Deliverables
Migration
Level 1 Clinical ICF based on T4.1.1, T4.2.1 and D4.15Migration
Training Materials for patients and to increase awareness about R&D, and to clarify essential aspects of data privacy laws and regulations in R&DMigration
Toolkit for the identification, selection, and measurement of outcomes in real world settings for BD4BO projectsMigration
Narrative: The consortium narrative that communicates the purpose of the BD4BO programmeMigration
Establish unmet ‘big data’ data needs of the health care systemMigration
Provide quarterly updates on key learnings from BD4BO projects about outcomes standardisation and methodological issuesMigration
Level 2 Non-Clinical ICFMigration
Level 3 Biobanking ICFMigration
Develop a targeted outreach plan for external collaboration with stakeholdersMigration
Develop interim/short-term strategic guidance documentMigration
Interim guidance document for existing BD4BO projects on approach proposed by the Distributed Data Network working groupMigration
Level 3 Non-Clinical ICFMigration
Develop the overall BD4BO programme strategy/long-term strategic guidanceMigration
Level 2 Biobanking ICFMigration
Level 3 Clinical ICFMigration
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 ICFMigration
Summary of the empirical investigation results, including proposal on method in order to integrate survey resultsMigration
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 outputsMigration
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 implementedMigration
Development of BD4BO online repositoryMigration
Run DPEC-R F2F workshop to collect input on critical data privacy topicsMigration
DPEC-O F2F workshop to collect input on critical data privacy topicsMigration
Publications
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
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
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
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
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/
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