Key activities involved in conduct of clinical trials / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12)2000.
Article
in Chinese
| WPRIM
| ID: wpr-679251
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Year:
2000
Type:
Article
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