问答

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

我们公司一个项目被一个以营销策划为主的第三方公司稽查，好像此公司经营范围有〝医学研究与试验发展〞，我的问题是目前大家选择第三方稽查目的何在？是想通过CFDI标准还是提供策略......

2019-06-05 10:40:38
目前大家招募工作中用到过给潜在受试者发邮件、电话介绍研究的情况吗?研究中心或招募公司。内容伦理批准。还没实际进行，准备做。我有点顾虑，潜在受试者是不是觉得被骚扰了，类似10086的电话。

2019-06-05 10:36:45
Do you have any experience in dealing with temperature deviations from commercially available drugs (cold chain) from patients? Usually, we have appropriate judgments for clinical trial drugs, but commercial products are placed in the hands of patients without strict temperature monitoring, and the collected temperature data is difficult to ensure accuracy. Please advise on whether there are any additional issues that need to be considered in addition to product stability when dealing with this issue
2019-06-04 09:14:00
如果方案和ICF有更新，涉及到遗传信息的变更，伦理已经批准但是遗传办还没有批，那么要不要立即执行新版方案和知情？知情内容还涉及到安全信息的变更。

2019-06-04 08:59:51
如果双盲试验，有非盲的研究团队设计（给药人员知道具体用药），安慰剂和试验药在包装上是否要保持一致？

2019-04-15 14:44:10
盲法试验中，安慰剂做对照药需要满足哪些条件？是否需要提供稳定性数据？

2019-04-15 14:43:38

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