问答

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

If the position of the page number and version date on the footer of a material submitted for ethics is adjusted during printing, such as when the left page number and right version date are used for ethics submission, and the left version date and right page number are used for printing, the theme content remains unchanged, but the material saved by the ethics committee is different from the one saved in the site file. How to define such a problem? What is the impact? How to handle it?
2017-07-04 09:47:31
Are there any regulations in China regarding the use of assessed or pre approval access to unauthorized medical products?
2017-07-04 09:47:05
When conducting the development or validation of certain testing methods in the central laboratory, it is sometimes necessary to obtain blood from healthy individuals. If this blood sample is taken from volunteers (non clinical trial subjects, such as central laboratory employees), do they need to sign an informed consent form? Is there any relevant regulations in our country that explain this situation?
2017-07-04 09:46:40
Should the first phase of the experiment be audited
2017-07-04 09:46:16
Do you make it mandatory to include contact number of local IRB / IEC on the ICF
2017-07-04 09:41:10

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