问答

Statement: The content of this Q&A reflects the current views of CQAF, for mutual learning and exchange among industry colleagues.

I期病房中开展的临床实验项目，比如BE或I期、PK等项目中，常有2个PI的操作，一个是I期病房主任，教育背景大都是药学；另一个是临床对应科室主任。这种情况，试验文件的签字，比如授权表、合同、与伦理委员会的沟通等，如何操作才算合规？

2019-04-15 14:41:27
I期病房中开展的临床实验项目，比如BE或I期、PK等项目中，常有2个PI的操作，一个是I期病房主任，教育背景大都是药学；另一个是临床对应科室主任。这种情况，试验文件的签字，比如授权表、合同、与伦理委员会的沟通等，如何操作才算合规？

2019-04-15 14:39:48
对于受试者交通补贴的支付方式和时间点，是否有对应法规要求？

2018-11-17 10:51:31
目前用微信发布的临床试验受试者招募广告越来越多，形式各样、制作精美，内容也具有一定的鼓动性。请问，受试者招募广告递交伦理委员会审批的时候，是否需要同时说明招募广告的发布途径？

2018-11-17 10:44:49
ArrayIf a clinical trial protocol requires more than 6 visits, a subject will upgrade the protocol to version 2.0 upon completion of V2, and the informed consent form of our center will be upgraded to version 2.0 and obtain ethical approval. The researchers and participants were informed according to the content of the 2.0 version of the informed consent form, but the participants stated that they need to consider before deciding whether to agree. This informed consent process is properly recorded in the original records. During V3 and V4, the subjects stated that they were still considering it because they did not sign the informed consent form. Therefore, the operations of V3 and V4 continued to follow the 1.0 version protocol. After the end of V4, the subjects only signed the 2.0 version informed consent form. So, does the subject need to report protocol violations for treatment during V3 and V4
2018-11-17 10:38:06
CoA中药物有效期信息为：2018-4，项目管理团队理解IP失效日期为2018-4-30，是否正确？

2018-11-17 10:32:18

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