Strengthen the management of external provision of human genetic resource information in clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.