问答

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

请教各位一个签字页的问题。如果一个文件的签字涉及多个地域，签字页原件是否可以用签字页复印件代替，仅保存最终一个签字人的原件？

2017-11-14 20:51:30
In multicenter clinical trials, central laboratories were used to test the main efficacy indicators. During the trial, due to the relocation of the laboratory to a new location and changes in the instruments used to test efficacy indicators, the performance verification report showed that the Bias compared with the new and old detection systems was greater than 5% but less than 10%. The results of the new instrument were higher than those of the old instrument, and the quality control results were in a controlled state. In order to restore the true efficacy of the drug under the same conditions, it is considered to retest the backup samples of all samples previously tested by the old instrument with the new instrument, but is this compliance? What laws, regulations, and technical guidance documents involve the retesting of central laboratory data
2017-09-24 09:52:16
众所周知，稽查是申办方的责任（China GCP第六章第三十二条）和权利（China GCP第六章第三十九条），那么，只有申办方可以发起稽查吗？(2017-7-12)

2017-07-18 10:15:26
GSP的适用范围是否包括临床试验药品，还是只适用于商业药品？(2017-6-26 )
2017-07-18 10:14:46
如果服务商采用了市售电子系统（软件系统：如统计分析，电子数据采集系统，IWRS随机系统），我们在考察服务商时，如何考察该电子系统是否为经验证的系统呢？在考察这一块时，需要考察服务商什么内容？(2017-7-11)

2017-07-18 10:12:56
临床试验GDP原则？
2017-07-04 10:04:11

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