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GB/T 42168.1-2022Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

January 1, 2024

Scope

GB/T 42168.1-2022 (Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports) is available as an English-translated PDF.

GB/T 42168.1-2022 is the Chinese standard "Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports". Its scope clause reads: This document is provided to aid in the design, execution, analysis and interpretation of clinical functional studies according to the requirements of ISO 23409.

This document is applicable to compare the performance of the new male condom and the marketed male condom during vaginal intercourse (non-anal intercourse). research The primary objective of the study was to assess acute failure events (i.e., clinical slippage and clinical breakage) during use.

This document also provides an analysis of the data at the completion of the study, as well as an interpretation of the results by the manufacturer and regulatory agencies, etc. Certain clinical trial elements, including compensation, confidentiality of personal information and records, participation of local ethics committees, etc., are not specified in this document, which are These and other clinical trial design issues are discussed in detail in ISO 14155. Its clauses include terms and definitions.

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Document preview — GB/T 42168.1-2022

National Standard of the People's Republic of China

ICS: 11.200
Classification: C 36

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Pre-clinical research
5 Clinical Validation Study
5.1 Purpose of Clinical Validation Study
5.2 Results Evaluation Index
5.3 Study subjects
5.4 Informed Consent
5.5 Test and control condoms
5.6 Random grouping
5.7 Concealment Assignment and Research Concealment
5.8 Using additional lubricant
5.9 Guidance and related interactions for participating couples
5.10 Visit and data collection
5.11 Data integrity
5.12 Distribution chain management
5.13 Analysis of recalled used condoms
5.14 Other methodological details
5.15 Statistical Analysis Plan
5.16 Clinical Study Results. Examination and Interpretation
Appendix A (Informative) Effectiveness Calculation Formula
Appendix B (Informative) Preliminary Clinical Study (Example Outline)
Appendix C (Informative) Research Subject Evaluation Plan Form (Example)
Appendix D (Informative) CRF---Example Form 17 for Initial Participation in Research
Appendix E (Informative) CRF --- Research Period (Example)
Appendix F (informative) CRF --- single condom use (example)
Appendix G (Informative) CRF---Adverse Event (Example)
Appendix H (Informative) Assessment Program for Recycling Used Condoms

1 Scope

This document is provided to aid in the design, execution, analysis and interpretation of clinical functional studies according to the requirements of ISO 23409.

This document is applicable to compare the performance of the new male condom and the marketed male condom during vaginal intercourse (non-anal intercourse). research

The primary objective of the study was to assess acute failure events (i.e., clinical slippage and clinical breakage) during use.

This document also provides an analysis of the data at the completion of the study, as well as an interpretation of the results by the manufacturer and regulatory agencies, etc.

Certain clinical trial elements, including compensation, confidentiality of personal information and records, participation of local ethics committees, etc., are not specified in this document, which are

These and other clinical trial design issues are discussed in detail in ISO 14155.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

The address of the terminology database for standardization maintained by ISO and IEC is as follows.

Note. All clinical failure events described below refer to possible vaginal exposure to semen and other penile secretions. There is no risk of exposure for nonclinical failure events.

3.1 Clinical breakage

A condom breaks or tears during intercourse or when the penis is withdrawn from the vagina.

Note 1.This may not be discovered until the condom is checked at the end of intercourse.

Note 2.All breakages that do not meet the definition of clinical breakage are considered "non-clinical breakage" (e.g. tearing a condom when opening the package).

3.2 clinical breakage rate

The number of condoms broken or torn during intercourse or penile withdrawal divided by the total number of condoms used during intercourse.

Note. Usually the clinical damage rate is expressed as a percentage.

3.3 clinical slippage

Complete slippage of the condom during intercourse or withdrawal of the penis from the vagina.

Note 1.Occasionally, slippage occurs because the user does not secure the condom at the base of the penis during withdrawal, and/or the user delays withdrawal after intercourse. this

These events were considered user-related failures and recorded as "non-clinical slippage". These events were not counted when calculating the number of clinical slip events.

Note 2.If the condom slips mainly due to breakage, it will not be recorded as a slip event.

YY/T 1777 | YY/T 1783 | YY/T 1797 | GB/T 47200 | GB/T 42168.2 | GB/T 44875 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 71 pages — is available in the English PDF.

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