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The MILESTONE study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.

GCP-trained personnel will conduct the study and ethical approval for the trial and all patient information will be in place prior to the commencement of the study. All data will be stored securely and anonymised in accordance with national legislations.

Any substantial protocol amendments (e.g. changes to eligibility criteria, outcomes, analyses) will be communicated to relevant parties and approvals sought as required prior to implementation.

An independent Scientific Clinical and Ethical Advisory Board (SCEAB) will monitor the proper conduct of the trial and other MILESTONE activities. Furthermore, the MILESTONE project incorporates an ethics work package whose work has influenced the design of the trial, intervention and selection of assessment tools. Moreover, from the beginning, there will be a focus on ethics related to various aspects of the MILESTONE study. This work is connected to a separate Workpackage (WP6).

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