Drug clinical trial data on-site verification points

In order to standardize drug clinical trial data on-site verification, China Food and Drug Administration formulated the "drug clinical trial data on-site verification points", hereby release and related matters are announced as follows:
 First, China Food and Drug Administration will apply for registration under "drug clinical trial data on-site verification points", for complete self-examination information furnished one by one drug clinical trial data on-site verification.
 Second, some of the drugs clinical trial data from the on-site verification of the case has been completed, the part of the drug clinical trial institution exists unauthorized modification of data, data, and data is not traceable concealed fraud and other issues, China Food and Drug Administration announced the discovery along together, and The applicant for registration, clinical trials institutions, clinical trials contract research organizations and related persons responsible be severely dealt with according to law.
 Third, clinical trials or clinical trials contract research organization should continue in accordance with the "drug clinical trial data on-site verification points", the authenticity of test data integrity self-examination, found unreal problems, countries should take the initiative to report Food and Drug Administration, and the initiative to urge the applicant to withdraw the application. Clinical trials contract research organization or organizations proactively report problems, may be exempted from accountability.
 Fourth, the applicant has found that the presence of drug registration clinical trial data authenticity may be directed to China Food and Drug Administration for withdrawal. In the China Food and Drug Administration notice on-site verification of application is withdrawn before the initiative, publish a list of applicants and varieties, not to be held accountable; after notification to accept the withdrawal of the application is no longer on-site verification.