Strengthen the management of external provision of human genetic resource information in clinical trials
10.3760/cma.j.cn113565-20211207-00193
- VernacularTitle:加强对临床试验中人类遗传资源信息对外提供的管理
- Author:
Huaying FAN
1
;
Chao SONG
;
Huiying RAO
Author Information
1. 北京大学人民医院科研处 临床试验机构 100044
- Keywords:
Human genetic resources;
Data information;
External provision;
Clinical trial
- From:
Chinese Journal of Medical Science Research Management
2022;35(2):81-85
- CountryChina
- Language:Chinese
-
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.
