In order to further standardize the on-site verification of clinical trials of registration for food for special medical purpose, the State Administration for Market Regulation formulated the Key Points and Judgment Principles for On-site Verification of Clinical Trials for Registration of Food for Special Medical Purpose (hereinafter referred to as the Key Points for Verification) in accordance with the Measures for the Administration of Registration of Food for Special Medical Purpose and the Quality Management Practices for Clinical Trials of Food for Special Medical Purpose, which will be implemented from the date of promulgation.

The Key Points for Verification set verification items based on the clinical trial process, covering the entire process of clinical trials, and sets 56 verification items in 10 aspects, including clinical trial conditions and compliance, ethical review, informed consent, subject screening, clinical trial program execution, safety information processing and reporting, clinical trial records, clinical trial data traceability, trial sample management, and biological sample management. The specific verification content focuses on the consistency between the original data and the registration application materials, as well as the important data or records that affect the product safety, nutritional adequacy, and clinical effect evaluation of special medical purposes. At the same time, it takes into account factors that affect the quality and reliability of clinical trials, including the qualifications and capabilities of all parties involved in the clinical trial and the implementation of their responsibilities, the integrity and traceability of the trial process, etc.

The Key Points for Verification clearly defined nine "failure" situations involving authenticity, integrity, legality and traceability, including fabricating or concealing test data, concealing serious adverse events and their severity, and using false test samples.

Source: SAMR

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