YY/T 1998-2026General requirements for clinical investigation of in vitro diagnostic reagents (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. This document is published. The organization is not responsible for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the national technical standardization authority for clinical evaluation of medical devices. This document was drafted by: the Center for Medical Device Evaluation, National Medical Products Administration; and the Food and Drug Evaluation Center, National Medical Products Administration. Inspection center. The main drafters of this document are. Lü Yunfeng, He Jingyun, Li Ran, Li Xiaoli, Wang Jianan, and Yan Juan. General Quality Requirements for Clinical Trials of In Vitro Diagnostic Reagents

1 Scope

YY/T 1998 is the quality framework for an IVD clinical trial in China. It specifies the general quality requirements for the whole course of a clinical trial carried out to assess the clinical performance and the safety of an in vitro diagnostic reagent: the trial plan, the protocol design, the conduct, the monitoring, the auditing and the inspection, and the collection, recording, retention, analysis, summarisation and reporting of the data. It is the IVD counterpart of good clinical practice, covering the process rather than the assay, and it is what a Chinese inspector reads the trial file against. For a manufacturer running a Chinese clinical trial for a diagnostic reagent, or a CRO conducting one, this is the standard that defines what an acceptable trial looks like from protocol to final report.

This document outlines the quality control procedures for the entire clinical trial process used to evaluate the clinical performance and safety of in vitro diagnostic (IVD) reagents. General requirements, including clinical trial planning, protocol design, implementation, monitoring, auditing, inspection, and data collection, recording, storage, analysis, and summarization. Conclusions and reports, etc. This document applies to clinical trials of in vitro diagnostic reagents for registration purposes.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

YY/T 1956-2025 Terminology and Definitions for Clinical Trials of In Vitro Diagnostic Reagents

3 Terms and Definitions

The terms and definitions defined in YY/T 1956-2025 apply to this document.

4 Ethical considerations

4.1 General Requirements Clinical trials of in vitro diagnostic reagents should comply with the ethical guidelines of the Declaration of Helsinki of the World Medical Congress and national regulations concerning human life sciences. And relevant regulations on ethical review of medical research. The design and implementation of clinical trials should ensure that the rights, safety, dignity, and health of participants are protected and are elevated above their rights. He prioritizes all interests and ensures that clinical trial data is scientifically valid, reliable, and robust. Throughout the entire clinical trial process, communication with the ethics committee should be maintained in accordance with relevant guidelines.

4.2 Undue influence or inducement Sponsors should avoid exerting undue influence on subjects, monitors, any investigators, or other parties involved in or facilitating clinical trials. Inducement. All researchers should avoid exerting undue influence on participants, sponsors, monitors, other researchers, or other parties involved in or facilitating clinical trials. When it influences or induces.

4.3 Compensation, indemnification, and additional medical services Where permitted by national regulations, appropriate compensation may be provided for costs incurred by participants in clinical trials (e.g., transportation expenses). Compensation should be provided, but the amount should not be too large, so as not to unduly encourage subjects to participate or influence subjects to withdraw from clinical trials prematurely. For subjects who experience adverse events as a result of participating in clinical trials, additional medical services should be arranged and documented. The following should be provided to the participants in the informed consent form.