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,
It contains:
  • 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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