问答

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

Two questions about the clinical trial of COVID-19: 1) At present, the testing and treatment costs of patients are reimbursed by the national or local medical insurance. How to deal with the testing costs of patients participating in the clinical trial of COVID-19? 2) Due to the high false negative rate of test results, the frequency of patient testing is even higher than the protocol requirements, and there are many testing methods (such as nasopharyngeal swabs, sputum, feces, mouthwash, etc.). Considering that the testing methods and conditions vary in different regions, and many patients may experience negative throat swabs but positive sputum culture, etc. If one method is strictly restricted, it may affect judgment, Therefore, there is no clear detection method in the plan. In this case, if paid by the applicant, should all inspections be paid by the applicant
2020-04-13 11:23:19
关于SOP的两个问题：1) SOP内容涉及到跨部门合作，该SOP是否需要在建立过程中，让涉及到的部门参与审核？
2.) 外资药企在中国的SOP，假如属于global SOP，内容操作也是一致的，比如Site initiation visit process, 它是一份纯中文版本和一份纯英文版本，两个文件呢？还是一份中英文对照文件，采用一段英文再一段中文的格式？

2020-04-13 11:22:42
新冠肺炎痊愈病人的血清是否可以寄送？

2020-04-13 11:21:52
关于收集身份证复印件：1）收集受试者身份证复印件是必要的吗？
2）有的公司要求收集IW的ID复印件，这个做法是否合适。

2020-04-13 11:20:52
ArrayTwo questions about Protocol Deviation (PD): 1) Is there a regulation that defines it? 2) How should the grading of PD be managed
2020-04-13 11:19:42
eConsent有没有监管单位发布对应Guideline? 国外是否已有eConsent 的实例？

2020-04-13 11:18:52

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