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Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 42168.1-2022: Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports Status: Valid
Basic dataStandard ID: GB/T 42168.1-2022 (GB/T42168.1-2022)Description (Translated English): Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C36 Classification of International Standard: 11.200 Word Count Estimation: 42,487 Date of Issue: 2022-12-30 Date of Implementation: 2024-01-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 42168.1-2022: Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self reports---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. ICS 11.200 CCSC36 National Standards of People's Republic of China Condom Clinical Research Guidelines Part 1. Male condoms based on self-reported clinical function research (ISO 29943-1.2017, IDT) Posted on 2022-12-30 2024-01-01 Implementation State Administration for Market Regulation Released by the National Standardization Management Committee table of contentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Pre-clinical research 2 5 Clinical Validation Study 2 5.1 Purpose of Clinical Validation Study 2 5.2 Results Evaluation Index 2 5.3 Study subjects 3 5.4 Informed Consent 4 5.5 Test and control condoms 4 5.6 Random grouping 5 5.7 Concealment Assignment and Research Concealment 5 5.8 Using additional lubricant 6 5.9 Guidance and related interactions for participating couples6 5.10 Visit and data collection 6 5.11 Data integrity 8 5.12 Distribution chain management 9 5.13 Analysis of recalled used condoms9 5.14 Other methodological details9 5.15 Statistical Analysis Plan 10 5.16 Clinical Study Results. Examination and Interpretation 12 Appendix A (Informative) Effectiveness Calculation Formula 13 Appendix B (Informative) Preliminary Clinical Study (Example Outline) 14 Appendix C (Informative) Research Subject Evaluation Plan Form (Example) 16 Appendix D (Informative) CRF---Example Form 17 for Initial Participation in Research Appendix E (Informative) CRF --- Research Period (Example) 20 Appendix F (informative) CRF --- single condom use (example) 21 Appendix G (Informative) CRF---Adverse Event (Example) 28 Appendix H (Informative) Assessment Program for Recycling Used Condoms30 Reference 35forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. This document is part 1 of GB/T 42168 "Guidelines for Clinical Research of Condoms". GB/T 42168 has issued the following parts. --- Part 1.Male condom based on self-reported clinical function research. This document is identical to ISO 29943-1.2017 "Guidelines for clinical research on condoms Part 1.Male condoms based on self-report Clinical Functional Research". Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee of Family Planning Devices (SAC/TC169). This standard was drafted by. Shanghai Medical Device Inspection Institute, Henan Medical Device Inspection Institute, Qingdao London Durex Co., Ltd., Wuhan Jieshibang Sanitary Products Co., Ltd. The main drafters of this standard. Yao Tianping, Zhang Junzi, Su Lingyao, Ren Juan, Qian Xinyi, Deng Jie, Sun Kaifeng, Zhang Congjun.IntroductionGB/T 42168 "Guidelines for Clinical Research of Condoms" aims to guide the clinical research of condoms, and is proposed to be composed of two parts. --- Part 1.Male condom based on self-reported clinical function research. --- Part 2.Clinical functional studies of female condoms based on self-report. Male condoms made of natural latex rubber (NRL) have a long history of safety and effectiveness, and their Performance has been proven. However, male condoms made from new materials need clinical validation to ensure their performance in real-world use Not inferior to NRL condoms. Such clinical validation studies, called clinical functional studies, are designed to compare acute failure events (i.e., clinical slippage and incidence of clinical damage). Statistical analyzes based on non-inferiority comparisons ensured that differences were modest. All clinical failure events as defined in this document represent a risk of vaginal exposure to semen and other penile secretions. Non-clinical There is no risk of exposure in the event of a failure. This document is intended to aid in the design, implementation, analysis and interpretation of clinical functions performed in accordance with the requirements of ISO 23409 Synthetic Male Condoms. able to study. However, it can also be used with appropriate modifications to evaluate other male condoms, with additional criteria for improved efficacy or safety. Statement (please refer to Chapter 8 of GB/T 7544-2019). In addition to information on clinical validation studies, this guidance provides Proposals for curative research and statistical analysis plans. Attachments include previously used case report forms and protocols that may be modified or adapted. Note. According to the normative clinical requirements of the relevant standards, these studies were designed to select patients who agreed to use the test and control condoms for vaginal intercourse. couple. Incidentally, these studies also collected data on condom use during anal sex; of course, this was not the primary goal. In order to meet the research To meet the force requirements, it is crucial to collect adequate reports of condom use during vaginal intercourse. Study sponsors usually take precautions, Examples include initial screening and obtaining informed consent from research subjects and obtaining consent to condom use in this manner. These clinical functional studies are generally not aimed at directly evaluating the protection of condoms against pregnancy or sexually transmitted infections (STIs). Finally, it is important to realize that clinical functional studies of condoms are human studies. Therefore, the design, implementation and analysis of new condom clinical All persons involved in clinical research should be familiar with all relevant research standards involving subject populations, including ethical issues. For additional information, see ISO 14155. Condom Clinical Research Guidelines Part 1. Male condoms based on self-reported clinical function research1 ScopeThis 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 referencesThis document has no normative references.3 Terms and DefinitionsThe 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 clinicalbreakage 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 clinicalslippage 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 42168.1-2022_English be delivered?Answer: Upon your order, we will start to translate GB/T 42168.1-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 7 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 42168.1-2022_English with my colleagues?Answer: Yes. 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