Key activities involved in conduct of clinical trials
- VernacularTitle:临床试验的关键环节 节译自WHO《GCP手册:指南的补充》(2005年)
- Author:
Ai-Jian LI
;
Ning-Ning XIONG
;
Xiu-Qin WANG
;
- Publication Type:Journal Article
- Keywords:
clinical research;
trial protocol;
standard operating procedures;
managing trial data;
quality assurance
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.
