Clinical trials are an essential part of the drug development process to evaluate the safety and efficacy of new drugs. However, in the process of conducting clinical trials, due to various reasons, problems such as inaccurate data and non-standard operation may occur, which may affect the reliability and accuracy of trial results. Therefore, in order to ensure the impartiality, objectivity and accuracy of clinical trials, clinical trials need to be audited.
Audit is a procedure for inspecting, evaluating and verifying the process and results of clinical trials, the purpose of which is to discover and correct problems in the trial in a timely manner and ensure the authenticity, completeness and accuracy of the trial data. The objects of the audit include the test protocol, test operation, data recording and analysis, etc., covering the whole process of clinical trials.
However, not all clinical trials need to be audited. Generally speaking, the following situations need to be audited:
1.Research projects involving major public health issues or national key support;
2.clinical trials that involve ethical issues;
3.Clinical trials involving activities such as the collection, preservation, utilization, and external provision of human genetic resources;
4.Other circumstances that the State Food and Drug Administration or the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government deem necessary to be inspected.
For clinical trials in the above situations, the relevant regulatory authorities will conduct regular or irregular audits to ensure the standardization of the trial and the reliability of the data. For other general clinical trials, the regulatory authorities do not conduct routine audits.
Of course, in addition to regulatory audits, there are other safeguards to ensure the standardization of clinical trials and the accuracy of data. For example, clinical trial institutions need to conduct self-verification to ensure that the trial operation meets the specifications; The Data Monitoring Committee will monitor and verify the trial data in real time to ensure the authenticity and accuracy of the data. At the same time, the participants of the clinical trial will also supervise and check each other to ensure the fairness and standardization of the entire trial process.
In conclusion, although not all clinical trials need to be audited, the regulatory authorities will make judgments and decisions on a case-by-case basis. At the same time, various safeguard measures will also ensure the standardization of clinical trials and the accuracy of data, and provide strong support for the development of drug research and development and human health.