Practice and Experience of Application and Report for the Accreditation of Drug Clinical Trial Institution Qualification of Our Hospital
10.6039/j.issn.1001-0408.2015.22.05
- VernacularTitle:我院药物临床试验机构资格认定申报工作的实践与体会
- Author:
Guifeng WANG
;
Xueqin LI
;
Feng LIU
- Publication Type:Journal Article
- Keywords:
Drug clinical trial institution;
Application and report for qualification accreditation;
Good Clinical Practice
- From:
China Pharmacy
2015;(22):3040-3042
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To introduce the experience of application and report for accreditation of drug clinical trial institution qualification of our hospital,to provide a reference for other hospitals. METHODS:From the building of institution,drug clinical trial ethics committee,clinical trials of listed drugs,simulated qualification accreditation,and other aspects,the experience and key points of application and report for accreditation of drug clinical trial qualification of our hospital were summed up. RESULTS& CONCLUSIONS:Priority should be given to staffing(particularly the leaders of the institution),the installation of software and hardware (for system development,training,institution office and specialized department),and the building of ethics committee. Departments should share work experience of clinical trials of listed drugs and set up a self-inspection group to simulate qualifica-tion accreditation. Work procedures and methods of qualification accreditation should be clearly understood,the requirements of Good Clinical Practice,the standards for qualification accreditation,should be known well;Good Clinical Practice should be seri-ously implemented and the subjects’rights and interests should be protected,which will contribute to the successful completion of application and report for qualification accreditation.
