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Overseas clinical trials

Overseas clinical trials, Total:200 items.

In the international standard classification, Overseas clinical trials involves: Medical sciences and health care facilities in general, Laboratory medicine, Quality, Medical equipment, Pharmaceutics, Test conditions and procedures in general, Dentistry, Hospital equipment, Machine tools, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Birth control. Mechanical contraceptives, Veterinary medicine, Terminology (principles and coordination), Vocabularies, Construction materials.


RU-GOST R, Overseas clinical trials

  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 52379-2005 Good clinical practice (GCP)
  • GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
  • GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
  • GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
  • GOST R 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
  • GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
  • GOST R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
  • GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
  • GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • GOST ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
  • GOST R 54328-2011 Dentistry. Preclinical evaluation of dental implant systems. Animal test methods
  • GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories
  • GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
  • GOST R ISO 16256-2015 Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Overseas clinical trials

中華人民共和國國家衛生和計劃生育委員會, Overseas clinical trials

  • WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
  • WS/T 496-2017 Quality indicators in clinical laboratories
  • WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory

GSO, Overseas clinical trials

  • GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • BH GSO ISO 16256:2017 Clinical laboratory testing and in vitro diagnostic test systems -- Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • GSO ISO 16256:2016 Clinical laboratory testing and in vitro diagnostic test systems -- Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • OS GSO ISO 16256:2016 Clinical laboratory testing and in vitro diagnostic test systems -- Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • BH GSO ISO 3875:2017 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
  • OS GSO ISO 3875:2015 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
  • GSO ISO 3875:2015 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
  • OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device
  • GSO ASTM F3037:2021 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
  • OS GSO ISO 2433:2015 Machine tools -- Test conditions for external cylindrical and universal grinding machines with a movable table -- Testing of accuracy
  • BH GSO ASTM F3037:2022 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
  • BH GSO ISO 2433:2016 Machine tools -- Test conditions for external cylindrical and universal grinding machines with a movable table -- Testing of accuracy
  • OS GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties
  • GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Group Standards of the People's Republic of China, Overseas clinical trials

  • T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
  • T/SSFSIDC 015-2023 Clinical trial data collection requirements
  • T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
  • T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
  • T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
  • T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
  • T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
  • T/CGCPU 012-2020 File management standards for clinical trial institutions
  • T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
  • T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
  • T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
  • T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
  • T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
  • T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
  • T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
  • T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
  • T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain
  • T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
  • T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
  • T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
  • T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
  • T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
  • T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
  • T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
  • T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
  • T/CACM 1185-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Flesh goiter
  • T/CACM 1277-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Burn
  • T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
  • T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
  • T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
  • T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
  • T/CACM 1312-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Cholelithiasis
  • T/CACM 1242-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM GuZhong disease
  • T/CACM 1150-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Headed Carbuncle
  • T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
  • T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
  • T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
  • T/CACM 1302-2019 Guidelines for ophthalmology clinical diagnosis and treatment in Chinese medicine—External ophthalmoplegia
  • T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
  • T/CACM 1139-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysthymia
  • T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
  • T/CACM 1186-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Comedomastitis
  • T/CACM 1563.5-2024 Pharmacovigilance guideline for clinical application of Chinese patent medicine for external use
  • T/CACM 1202-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chronic Leg Ulcer
  • T/CAAM 0001-2023 Guidelines for clinical practice of evidence-based acupuncture and moxibustion lateral epicondylitis
  • T/CAV 009-2024 Quality control standards for on-site implementation of vaccine clinical trials
  • T/CACM 1287-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM White Lesions of the Vulva
  • T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
  • T/SHSPS 001-2024 Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai)
  • T/SHSPS 002-2024 Standards for the management and competency evaluation of clinical trial monitors (Shanghai)
  • T/CAQI 366-2024 Clinical testing quantitative project method confirmation
  • T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
  • T/ZSBT 001-2021 Acceptance Standards for clinical blood use management in Zhejiang Province
  • T/CAAM 0004-2023 Guidelines for setting up and reporting sham acupuncture controls in acupuncture clinical trials

GOST, Overseas clinical trials

  • GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
  • GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
  • GOST R ISO 17593-2009 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

American Society for Testing and Materials (ASTM), Overseas clinical trials

  • ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
  • ASTM E2045-99 Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM E2045-99(2003) Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM F2884-12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
  • ASTM F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)

Professional Standard - Medicine, Overseas clinical trials

  • YY/T 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
  • YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
  • YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
  • YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials

Association Francaise de Normalisation, Overseas clinical trials

  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • NF S92-012*NF EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
  • NF E60-125*NF ISO 3875:2020 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
  • NF E60-125:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy.
  • NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties

IT-UNI, Overseas clinical trials

  • UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • UNI ISO 3875:2021 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy

US-AAMI, Overseas clinical trials

Danish Standards Foundation, Overseas clinical trials

  • DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
  • DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties

衛生健康委員會, Overseas clinical trials

Professional Standard - Hygiene , Overseas clinical trials

  • WS/T 834-2024 Clinical application of Toxoplasma gondii test
  • WS/T 251-2005 Guidelines for Clinical Laboratory Safety
  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
  • WS/T 442-2014 Guideline for clinical laboratory biosafety
  • WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
  • WS/T 249-2005 Clinical Laboratory Waste Management
  • WS/T 102-1998 Classification and codes of clinical laboratory tests item
  • WS/T 418-2013 Guidelines for the selection of referral clinical laboratories
  • WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
  • WS/T 255-2005 Clinical laboratory medicine Reguirements for reference measurement laboratories

British Standards Institution (BSI), Overseas clinical trials

  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
  • 21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
  • BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

European Committee for Standardization (CEN), Overseas clinical trials

  • EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
  • EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)

AENOR, Overseas clinical trials

  • UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
  • UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.
  • UNE-EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim

PL-PKN, Overseas clinical trials

  • PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

German Institute for Standardization, Overseas clinical trials

  • DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Lithuanian Standards Office , Overseas clinical trials

  • LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

AT-ON, Overseas clinical trials

  • OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • ONORM M 9030-1998 Machine tools - Acceptance conditions for external cylindrical grinding machines

Zhejiang Provincial Standard of the People's Republic of China, Overseas clinical trials

  • DB33/T 903-2013 Classification and coding of clinical laboratory test items

Korean Agency for Technology and Standards (KATS), Overseas clinical trials

  • KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacture
  • KS B ISO 3875:2014 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
  • KS B ISO 3875:2013 External cylindrical centerless grinding machines-Testing of the accuracy
  • KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
  • KS P ISO 17593:2009 Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
  • KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects-Part 2:Clinical investigation plans
  • KS B ISO 3875:2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
  • KS P ISO TR 18112-2020 Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer
  • KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties

International Organization for Standardization (ISO), Overseas clinical trials

  • ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO 3875:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
  • ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
  • ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
  • ISO 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO 3875:2020 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy

司法部, Overseas clinical trials

Professional Standard - Certification and Accreditation, Overseas clinical trials

US-CLSI, Overseas clinical trials

  • CLSI MM19-A-2011 Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline

ZA-SANS, Overseas clinical trials

  • SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties

Professional Standard - Public Safety Standards, Overseas clinical trials

Japanese Industrial Standards Committee (JISC), Overseas clinical trials

  • JIS B 6220:2021 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy

SCC, Overseas clinical trials

  • DANSK DS/ISO 17593:2007 Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
  • DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
  • BS 4656-24:1980 Specification for the accuracy of machine tools and methods of test-Cylindrical external centreless grinding machines
  • DANSK DS/EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems – Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

Canadian General Standards Board (CGSB), Overseas clinical trials

Shanxi Provincial Standard of the People's Republic of China, Overseas clinical trials

  • DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

IN-BIS, Overseas clinical trials

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Overseas clinical trials

Professional Standard - Agriculture, Overseas clinical trials

KR-KS, Overseas clinical trials

  • KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties
  • KS P ISO 16256-2022 Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infec
  • KS B ISO 3875-2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy

Hunan Provincial Standard of the People's Republic of China, Overseas clinical trials

  • DB43/T 2135-2021 Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects

BE-NBN, Overseas clinical trials

  • NBN-EN 540-1993 Clinical investigation of medical devices for human subjects

Anhui Provincial Standard of the People's Republic of China, Overseas clinical trials

  • DB34/T 4619-2023 Guidelines for the Construction of Intelligent Research Laboratory for Drug Phase I Clinical Trials

GOSTR, Overseas clinical trials

  • GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer




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