Key points of on-site verification of clinical trial data released by CFDA

Source: CFDA 2015-11-11 in order to standardize the on-site verification of drug clinical trial data, the State Food and drug administration has organized and formulated the key points of on-site verification of drug clinical trial data, which are hereby released, and the relevant matters are announced as follows: I The State Food and Drug Administration will, in accordance with the key points of on-site verification of drug clinical trial data, conduct on-site verification of clinical trial data one by one for drug registration applications completed with self-examination data 2 According to the on-site verification of some completed clinical trial data of drugs, some clinical trial institutions have falsification problems such as unauthorized modification of data, concealment of data and non traceability of data The State Food and Drug Administration will publish the findings together, and make a report on the registration applicant, clinical trial institution, research organization and phase of clinical trial contract The person in charge shall be dealt with seriously according to law III clinical trial institutions or clinical trial contract research organizations shall continue to conduct self-examination on the authenticity and integrity of the test data in accordance with the key points of on site verification of clinical trial data of drugs If any untrue problem is found, they shall take the initiative to report the situation to the State Food and Drug Administration and urge the applicant to withdraw the application If the clinical trial institution or contract research organization actively reports the problem, it can be exempted from the responsibility IV if the applicant for drug registration finds that there is any authenticity problem in the clinical trial data, he may apply to the State Food and Drug Administration for withdrawal If an application for withdrawal is made voluntarily before the State Food and Drug Administration notifies the on-site inspection, the list of applicants and varieties shall be published and no responsibility shall be investigated; the withdrawal application shall not be accepted after the on-site inspection is notified It is hereby announced Appendix: key points of on-site verification of drug clinical trial data annex.docx to announcement No.228 of food and Drug Administration on November 10, 2015