Ethical Research on Quality Control in Drug Clinical Trials
10.12026/j.issn.1001-8565.2016.04.33
- VernacularTitle:药物临床试验质量控制的伦理研究?
- Author:
Ruiping LU
;
Yi CHENG
- Publication Type:Journal Article
- Keywords:
Clinical Trials;
Quality Control;
Ethical Research;
Ethics Committee
- From:
Chinese Medical Ethics
2016;29(4):652-654
- CountryChina
- Language:Chinese
-
Abstract:
Guided by good clinical practice ( GCP) , M hospital cooperated with the Ethics Committee in quali-ty management of clinical trials and took the specific measures including perfecting the institution and standard op-erating procedures, implementing three level quality control institution, strengthening the training of GCP, and closely cooperating with drug and data management of clinical trials, quality control in the clinical trial, ethical re-view and supervision, quality control in the whole process (seamless connection). Seamless connection from the beginning of project acceptance and quality control in the whole process of clinical trials can effectively solve the ex-isting problems in clinical trials and improve the quality of clinical trials.
