Quality management plan (clinical conduct)

A system for applying quality management at the trial site so there is effective compliance with sponsor, applicable regulatory and ethical requirements



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According to ICH GCP, an investigator should conduct a trial in compliance with the protocol agreed to by the sponsor and, if required by the regulatory authority(ies) and which was given approval by the ethics committee. In addition, all persons assisting with the trial should be adequately informed about the protocol, the investigational product/study drug and their trial-related duties, for which they should be appropriately qualified to perform. It is recommended that PIs have a system whereby they manage quality throughout the trial. This procedure therefore describes how quality assurance and control may be applied at the trial site such that there is effective implementation, compliance with sponsor and applicable regulatory and ethical requirements, verification of data accuracy and identification of areas in need of corrective action.