问答

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

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
ICF不豁免的情况下，需要给受试者一份签字复件，以前的普遍做法是使用无碳复写文件，现在大都提供两份打印文件，研究者和受试者在两份文件上同时签字，那么，稽查中如何核对“复件”？

2018-11-17 10:29:53
试验用药物短期稍超温，如开冰箱门取药导致超温等都需要上报PD吗？

2018-09-29 13:05:11
健康受试者单剂量递增的1期临床研究中，方案规定达到设定的标准后方可进行下一剂量的试验。项目组考虑到筛选失败率较高，为节省筛选时间，如果在尚未知是否可以进行下一剂量试验时就开始筛选下一剂量的受试者，提前完成筛选期的相关检查，待符合标准可以进行下一剂量试验后就直接给符合试验的受试者药物。此做法如何制定finding？

2018-09-25 15:50:17

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