Within the framework of the announced Competition for the Establishment and Development of Clinical Research Support Centers financed by the National Plan for Reconstruction and Enhancement of Resilience (NERP) No. 2024/ABM/4/KPO, an update of the Standard for Model Clinical Research Support Center (CRSC), version 3.0, was prepared.
The update was carried out, among other things, to bring the nomenclature used in the document in line with European guidelines and the terminology used. In addition, in response to requests from previous Beneficiaries of the competitions for the establishment and development of Clinical Research Support Centers No. ABM/2020/3, ABM/2021/4 and ABM/2021/6, changes were made to the qualifications of CRSC staff, bringing the guidelines in line with current market and economic realities, as well as the Beneficiaries' past experience.
The changes include the issue of experience in monitoring and coordinating clinical trials, additional personnel responsible for negotiating contracts, and the requirement for ICH GCP certification for specific positions. The unification of the Standard's provisions and the changes made will enable all Grantees to effectively establish and develop CRSC, and thus implement clinical trials.
The document is available under Files-Materials for research centers
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