Key activities involved in conduct of clinical trials / 中国临床药理学与治疗学
Article
en Zh
| WPRIM
| ID: wpr-679251
Biblioteca responsable:
WPRO
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.
Texto completo:
1
Banco de datos:
WPRIM
Idioma:
Zh
Año:
2000
Tipo del documento:
Article