Analysis of Ethical Initial Review Status of Drug Clinical Trail Institutions in Shaanxi Province
10.3870/j.issn.1004-0781.2024.10.017
- VernacularTitle:陕西省药物临床试验机构伦理初始审查的现况分析
- Author:
Yurong ZHANG
1
;
Ruizhong WANG
;
Li WANG
;
Rui XU
;
Kun WEI
Author Information
1. 西安医学院第一附属医院药物临床试验机构,西安 710077
- Keywords:
Drug clinical trial;
Ethical;
Initial review
- From:
Herald of Medicine
2024;43(10):1636-1639
- CountryChina
- Language:Chinese
-
Abstract:
Objective To examine the process of the initial ethical review of drug clinical trials in medical institutions in Shaanxi province,analyze the current situation of initial reviews,and make suggestions to expedite the speed of initial ethical review of drug clinical trial projects.Methods Based on the drug clinical trial institutions in Shaanxi recorded in the"drug and medical device clinical trial institutions for the record management information system".This study involved retrieving information through hospital website,WeChat public accounts,and conducting telephone consultations to usnderstand the process.The analysis focused on the initial review requirements,documents submission,and approval documents.Results A total of 44 drug clinical trial institutions were assessed.63.6% of these institutions had clearly issued ethical review/application guidelines,with some lacking detailed provisions on the initial review submission list,simplified data and seal requirements.31.8% of the institutions had established ethics review management systems.The average time of obtaining ethics approval was from 5.13 to 6 d.Conclusion It is recommended to further improve ethical review guidelines,standardize the initial review process,refine the initial ethical review documents and institutional project approval documents,build an information management platform,reduce the time for initial review of drug clinical trial projects,and improve the speed of clinical trial initiation.
