Discussion on the management model of subject screening and reasonable application of subject databases in phase Ⅰclinical trials in China
10.13699/j.cnki.1001-6821.2016.08.026
- VernacularTitle:探讨合理应用受试者数据库管理我国Ⅰ期临床试验筛选过程
- Author:
Ran XIE
;
Xiao CHEN
;
Xia ZHAO
;
Yi-Min CUI
- Keywords:
phase Ⅰ clinical trial;
subject;
screening;
subject data-base;
subject networking database
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(8):749-752
- CountryChina
- Language:Chinese
-
Abstract:
It is particularly important to confirm that whether subjects were repeated to participate in the clinical trial, the time interval from the last dose in the recent clinical trial, whether the physical conditions of subjects accord with the clinical trial protocol in phase I clinical trials and so on.This paper will introduce two types of the subject database, one was established by our hospital, another one is subject networking database, and will introduce the operation mode, the present situation of subjects screening under the database management. To explore the existing problems, optimize the use of subject database and give long-term prospects of subject networking database.
