This deliverable describes the actions applied to the BD2Decide project to guarantee compliance to all Ethics aspects concerned with the project execution and the management of the clinical study,
- A summary of the application scope.
- The definition of the Ethics Framework for the project.
- The details of all ethics aspects addressed and the implemented monitoring activities.
- The main roles (persons, organizations and bodies) that overview on ethics.
- The description of the mechanisms applied to ensure ethics management.
- The description of the mechanisms to ensure effective management in case of breach of ethics.
In addition, appendixes provide the following reference material:
- Ethics approvals by Ethics Committees of participating centres.
- Templates of the Informed Consent forms signed by patients enrolled for the BD2Decide clinical study.
- References to important documents.
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