文档介绍：actively carry out the law on civil air defense education, drawn out of the air defense in Pingliang city Building under
中国GCP历程?
- 1998年卫生部定稿批准，1999年SDA颁布执行，2003年9月1日SFDA修订后再颁布执行。
actively carry out the law on civil air defense education, drawn out of the air defense in Pingliang city Building under easy fare, daily special inspection and regulation, overfulfilled the province upper and lower knots of up to 500,000 yuan fee collection tasks. 5, further standardize internal management, improve staff quality. Adhere to the
实用文档
actively carry out the law on civil air defense education, drawn out of the air defense in Pingliang city Building under easy fare, daily special inspection and regulation, overfulfilled the province upper and lower knots of up to 500,000 yuan fee collection tasks. 5, further standardize internal management, improve staff quality. Adhere to the
GMP、GLP、GSP中文名称?
GMP——药品生产质量管理规范。
GLP——药品非临床研究质量管理规范。
GSP——药品经营质量管理规范。
8．为保证临床试验的质量，应该遵守哪三个原则?
伦理原则、科学原则和符合相关法规原则。
9．何为SOP?
标准操作程序(Standard Operation Procedure，SOP)，就是将某一事件的标准操作步骤和要求以统一的格式描述出来，用来指导和规范日常的工作。药物临床试验中的SOP为有效地实施和完成某一临床试验中每项工作所拟定的标准和详细的书面规程。
10．制定SOP的目的是什么?
为确保临床试验方案中所设计的内容能被准确无误地执行和落实，是临床试验质量控制体系中的重要环节。
11．制订SOP的原则是什么?
依据充分、操作性强、清晰准确、避免差错、格式统一。写所要做的，做所写的，记录所做的
12．我院药物临床试验运行流程：
申办方递交材料
机构办受理立项
专业科室承接
actively carry out the law on civil air defense education, drawn out of the air defense in Pingliang city Building under easy fare, daily special inspection and regulation, overfulfilled the province upper and lower knots of up to 500,000 yuan fee collection tasks. 5, further standardize internal management, improve staff quality. Adhere to the
实用文档
actively carry out the law on civil air defense education, drawn out of the air defense in Pingliang city Building under easy fare, daily special inspection and regulation, overfulfilled the province upper and lower knots of up to 500,000 yuan fee collection tasks. 5, further standardize inter