Report summarising cost of health care cost drivers in UK and Germany.
This deliverable (scheduled prior to enrolment of first study subject) includes: (a) a final version of study protocol as submitted to regulators / ethics committee(s) (no need to change deliverable if later amendments), (b) a registration number of clinical study in a WHO- or ICMJE- approved registry (please note: result posting for the study must be possible), and (c) approvals (ethics committees and national competent authority if applicable) required for invitation / enrolment of first subject in at least one clinical centre.
Standard Operating Procedures, including 1) the use of ECMO, 2) patient informed consent.
Trial governance report, including details of clinical staff contacts, roles and responsibilities of the individ-ual contacts to allow effective communication.
SOPs for outcome evaluation: Instructions for evaluation procedure.
MRI protocol: Report resulting in publication in an imaging speciality journal & open-access to the protocol.
Statistical analysis plan.
Dissemination and Outreach Plan (DOP): Comprehensive DOP with the support of all Partners.
Data Safety and Monitoring Board and Ethics Board Report.
Training materials for sites in all relevant health economic aspects.
Training documents in the local languages of all partner site countries, including print and online material.
Author(s): Amerjeet Singh Banning, Tom Adriaenssens, Colin Berry, Kris Bogaerts, Andrejs Erglis, Klaus Distelmaier, Giulio Guagliumi, Steven Haine, Adnan Kastrati, Steffen Massberg, Martin Orban, Truls Myrmel, Alain Vuylsteke, Fernando Alfonso, Frans Van de Werf, Freek Verheugt, Marcus Flather, Manel Sabaté, Christiaan Vrints, Anthony H. Gershlick
Published in: EuroIntervention, Issue 16/15, 2021, Page(s) e1227-e1236, ISSN 1969-6213