问答

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

请问是否有“国际认证的GCP Site”概念？

2017-11-14 20:56:02
请教两个有关受试者个人信息和隐私保护的问题：1，中国是否有明确的法规规定哪些信息属于受试者个人识别信息和隐私，如姓名、性别、出生年月、个别疾病情况？2，在SAE汇报过程中，申办方可能会收到带有受试者个人信息的文件，比如住院病历、实验室检查报告单等。在报告申办方之前是否需要先处理个人信息？

2017-11-14 20:52:49
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

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