Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigator {29}
The sponsor and investigators will have access to the final trial dataset. There are no contractual agreements that limit such access. Dissemination and use of the data will be jointly agreed by the sponsor and investigators.The investigator will guarantee access to source documents for the trial monitor and auditors as well as for inspection by appropriate Regulatory Agencies/Competent Authorities, and Ethics committees (ECS), if required.