Introduction of the quality control system for the Capital's Funds for Health improvement and research / 中华医学科研管理杂志

ABSTRACT

Objective To establish the quality control system of the Capital's Funds for Health(CFH),strengthen the process management,and improve the clinical research capacity.Methods The framework,contents and implementation method of the quality control system were developed with comprehensively adopting methodologies of literature analysis,expert discussion,summaries of policy and practice experiences.Results This quality control system of the Capital's Funds for Health is comprised of three tiers.The first tier is self-assessment,the principle investigator takes the responsibility;the second tier is the sponsor verification,the sponsor organization takes the responsibility;the third tier is the independent audit,the CFH office takes the responsibility.The contents of quality control focus on the compliance with ethical approval and informed consent,data authenticity,protocol deviation,progress of project,and quality assurance methods taken during the project implementation.Conclusions This three-tier quality control system of the Capital's Funds for Health provides a new idea and scheme for the quality control of clinical research projects supported by funding agencies in China,and its impacts will be evaluated in next implementation practices.