Several committees provide governance for the HEAR registry. The steering committee ensures the overall management of the study (administrative, scientific, data quality, etc.), any subject related to science will be advised by the scientific committee and the monitoring of data quality will be advised mainly by the industrial committee and in part by the patient association.
1 – THE STEERING COMMITTEE
The Steering Committee makes decisions concerning the overall direction of the Project, and decides on the strategic orientations of the project.
The Steering Committee arbitrates in the event of a breach by one of the Partners in its contractual obligations and decides on the consequences of this breach.
2 – THE SCIENTIFIC COMMITTEE
The mission of the scientific committee is as follows:
– To provide scientific expertise, assistance and advice for the preparation and follow-up of the Study; proofreading and validation of the protocol and the questionnaire for the Study
– To advise the sponsor in the selection and recruitment of participating investigative centers
– To provide depending on the subject, if necessary, a presentation during meetings,
– To participate in monitoring the progress of the Study in France, the motivation of the investigative teams,
– To participate in a data review and validation meeting before launching statistical analyses, validation of the final analysis plan
– To participate in a meeting to review the results, review and validate the study report.
– To participate in meetings to prepare the scientific communication of the results, excluding the writing of publications.
The members of the committee will be elected by the steering committee at the beginning of the project from the principal investigator of centers that will participate in HEAR.
3 – THE CONSULTATIVE COMMITTEE
The consultative committee brings together the 2 expert committees.