Composition of the data monitoring committee, its role and reporting structure
ICH
Charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed.Data monitoring is under the responsibility of CTC UZA, that is independent from the sponsor and funder. A Clinical Monitoring Plan (CMP) was conjointly written by the CTC UZA, in collaboration with the chief investigators. The CMP establishes the guidelines for conducting monitoring visits and related tasks for monitoring protocol Long Covid. The CTC UZA will perform monitoring tasks in accordance with the protocol specific requirements. This plan aims to support the UZA monitor(s) to ensure that the investigational sites follow the International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines (GCP), the local regulatory requirements and he study protocol.