Answer： Chapter 2 of the "Guiding Principles for the Management of Phase I Clinical Trials of Drugs (Trial)" (Guo Shi Yao Jian Zhu [2011] No. 483) requires Article 4: "Applicants should establish a quality assurance system to monitor and audit the entire process of Phase I trials, ensure the quality of clinical trials, and safeguard the rights and safety of subjects." Article 21 of Chapter 5 "Quality Assurance" further explains the entire process of monitoring, The applicant should regularly verify the experimental projects according to the supervision plan to ensure the completeness, accuracy, authenticity, and reliability of the data. The frequency and nature of the verification should be determined based on the actual situation of the experiment. However, there is no specific requirement for whether each project must be inspected.The "Quality Management Standards for Clinical Trials of Drugs" in China emphasize that the applicant should establish a quality control and quality assurance system, and assume the responsibility of supervision and inspection. Based on this, can Article 4 be understood as a requirement for the responsibilities of the applicant, rather than targeting specific experimental projects? It is recommended to seek confirmation from the drug regulatory department.As for how the sponsor formulates an inspection plan, determines which product testing projects are under development, and which research centers for the testing projects should be inspected, the current advocated concept is "risk based quality management approach". This concept was clearly elaborated in EMA's 2013 "Reflection Paper on Risk Based Quality Management in Clinical Trial".