摘要
为使Ⅰ期药物临床试验实施更加规范,试验过程可溯源,结合Ⅰ期临床的特点和试验病房的管理要求,本文提出了除GCP要求必须保存的记录文件外,试验病房还应该建立其他管理文档,这些文档也是反映试验全部过程的重要补充文件,是保证临床试验顺利实施,结果真实可靠的重要文档。
To further specify Phase I clinical trial and achieve traceability of trial process, this article proposes that besides the files required by GCP, trial wards should also file other management documents, which are important additional documents reflecting the entire trail process and ensuring successful implementation of the trial and reliable results.
出处
《医院管理论坛》
2014年第1期42-43,共2页
Hospital Management Forum
基金
辽宁省教育厅创新团队项目(2008T127)
