D10.2 Risk Assessment Ethical monitoring and Contingency Plans
The present document is a deliverable of the VICINITY  project, funded by the European Commission’s Directorate-General for Research and Innovation (DG RTD), under its Horizon 2020 Research and Innovation Programme (H2020) .
The deliverable covers three important topics:
- It establishes the process to be used to identify, record, manage and monitor risk and the need for contingency planning when an identified risk cannot be completely avoided or mitigated.
- The Risk Register will be maintained as a specific project management document, stored on OwnCloud. The template for the Risk Register is included as Annex A. The template included here has not been populated, but the actual Risk Register has been created using the initial risks identified in the Description of Work.
- It describes how Failure Mode and Effect Analysis (FMEA) will be applied to the Risk Register to put in place appropriate contingency plans
- It defines the way that the project’s Ethics Advisory Board (EAB) will operate, and sets out a policy for ensuring the privacy of any person who becomes involved with the VICINITY trials.
- The template form has been created for obtaining the informed consent of any data subject / participant who will be involved with VICINITY trials. This is included as Annex B of this document.
- The Data Management Plan is presented: this will be overseen by the EAB. The Project Quality Board will review this document and suggest revisions if these are found to be needed during the life of the project.