WP9 Ethics Requirements
Objective of WP9
- To ensure compliance with the 'ethics requirements' set out in this work package.
These ethic requirements are included as deliverables in this work package
Approval for the clinical study must be obtained from the Ethical Committees of the Clinical Centers.
The manufacturing licence for the production of CAR T-cells will be provided to the European Commission.
Deliverable 9.3, 9.4, 9.8
All data collection and processing will be carried according to EU and national legislation, under the control of the competent Institutional Data Protection Officer and/or the National Data Protection Authority. Moreover, all the decision and reports of the Data and Safety Monitoring Boards (DSMB) related to the clinical study will be provided to the EC.
Authorizations for in vivo preclinical studies in mice must be obtained from the involved Institutions.