Independent, all-inclusive Data safety management through either an Ebola centralised WHO umbrella group or ad hoc DSMB

A Data Safety Monitoring Board (DSMB) must be in place. It woudl be preferably for all the EVD studies shoto be overseen by one single DSMB. Discussions are on-going at the time of writing this grant agreement to set-up such a central DSMB under the WHO umbrella. In the meantime, until established an ad hoc DSMB will be put in place, for independent ongoing monitoring of the efficacy and safety of the trial intervention. The minutes of the open-door meetings will be shared with the PCC. DSMB reports will be submitted as a seperate chapter of the period technical report. Any changes in the trial during the study period, resulting from DSMB deliberations, will be the subject of an ad hoc report to the Commission.