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Frontier Clinical Research

Frontier Clinical Research, Total:191 items.

In the international standard classification, Frontier Clinical Research involves: Vocabularies, Laboratory medicine, Medical equipment, Medical sciences and health care facilities in general, Birth control. Mechanical contraceptives, Dentistry, Hospital equipment, Pharmaceutics, Terminology (principles and coordination), Applications of information technology, Quality, Test conditions and procedures in general.


Group Standards of the People's Republic of China, Frontier Clinical Research

  • T/CAV 001-2023 Terms used in vaccine preclinical research
  • T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
  • T/CACM 015.12-2017 Chinese medicine clinical research verification standards
  • T/CGCPU 001-2015 Guidance for clinical research coordinator profession practice
  • T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
  • T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
  • T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
  • T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
  • T/GDPHA 029-2021 Standard Data Set of Clinical Research on Diabetes
  • T/CGCPU 001-2023 Specification for capacity evaluation of clinical trial coordinator
  • T/CACM 015.9-2017 Technical specification for the management of clinical research results of traditional Chinese medicine
  • T/CAAM 0002-2022 Acupuncture and moxibustion clinical research adverse event recording specification
  • T/GDPHA 015-2021 Data Element Standard for Clinical Scientific Research of Live Cancer
  • T/GDPHA 016-2021 Data Element Standard for Clinical Scientific Research of Gastric Cancer
  • T/GDPHA 028-2021 Standard Data Set of Clinical Research on Malignant Tumor Diseases
  • T/GDPHA 014-2021 Data Element Standard for Clinical Scientific Research of Lung Cancer
  • T/CACM 1323-2019 Technical Specifications for Supervision of Clinical Research Data of Traditional Chinese Medicine
  • T/GDPHA 012-2021 Data Element Standard for Clinical Scientific Research of Diabetes
  • T/GDPHA 005-2021 Data Element Standard for Clinical Scientific Research of Cerebral Hemorrhage
  • T/GDPHA 020-2021 Data Element Standard for Clinical Scientific Research of Mammary cancer
  • T/GDPHA 011-2021 Data Element Standard for Clinical Scientific Research of Anxiety Disorder
  • T/GDPHA 017-2021 Data Element Standard for Clinical Scientific Research of Esophageal Cancer
  • T/GDPHA 004-2021 Data Element Standard for Clinical Scientific Research of Cerebral Infarction
  • T/GDPHA 003-2021 Data Element Standard for Clinical Scientific Research of Coronary Heart Disease
  • T/GDPHA 008-2021 Data Element Standard for Clinical Scientific Research of Depression
  • T/GDPHA 006-2021 Data Element Standard for Clinical Scientific Research of Autism
  • T/GDPHA 019-2021 Data Element Standard for Clinical Scientific Research of Pancreatic Cancer
  • T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
  • T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
  • T/CACM 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
  • T/CAAM 0012-2020 Specifications for information collection of real-world acupuncture and moxibustion clinical research
  • T/CACM 015.11-2017 Formulation of technical specifications for the summary report of clinical research of traditional Chinese medicine
  • T/CAAM 0005-2022 General rules for the compilation of real-world acupuncture and moxibustion clinical research norms
  • T/CAAM 0009-2022 Data management specification for real-world acupuncture and moxibustion clinical research
  • T/CGCPU 017-2021 Quality control requirements for clinical research of CAR-T cell products
  • T/GDPHA 024-2021 Technical Standard for Property Protection and Exchange of Clinical Research Data
  • T/GDPHA 027-2021 Standard Data Set of Clinical Research on Mental Disease
  • T/CAV 003-2023 Guidelines for visiting site setting of prophylactic vaccine clinical research
  • T/GDPHA 018-2021 Data Element Standard for Clinical Scientific Research of Colorectall Cancer
  • T/GDPHA 002-2021 Data Element Standard for Clinical Scientific Research of Hypertension
  • T/GDPHA 001-2021 Data Element Standard for Clinical Scientific Research of Chronic Diseases
  • T/CGCPU 002-2016 The standard of on-site inspection for clinical investigational drug centralized management
  • T/GDPHA 021-2021 Data Element Standard for Clinical Scientific Research of Malignant Lymphoma
  • T/GDPHA 025-2021 Data Element Standard for Clinical Scientific Research of Diabetes
  • T/GDPHA 009-2021 Data Element Standard for Clinical Scientific Research of Schizophrenia
  • T/CAAM 0009-2020 Electronic medical record template specification for real-world acupuncture and moxibustion clinical research
  • T/CAAM 0006-2022 Data quality assessment specification for real-world acupuncture and moxibustion clinical research
  • T/GDPHA 026-2021 Standard Data Set of Clinical Research on Chronic Obstructive Pulmonary Disease
  • T/GDPHA 010-2021 Data Element Standard for Clinical Scientific Research of Bipolar Disorder
  • T/GDPHA 032-2021 Exchange Standards and Specifications for Clinical Research Data in Chronic Diseases
  • T/GDPHA 007-2021 Data Element Standard for Clinical Scientific Research of Alzheimer's Disease
  • T/GDPHA 013-2021 Data Element Standard for Clinical Scientific Research of Chronic Obstructive Pulmonary Disease
  • T/CACM 015.2-2017 Formulation of Standard Operating Procedures for Ethical Review of Traditional Chinese Medicine Clinical Research
  • T/ZSA 95-2021 Requirements for quality control on chimeric antigen receptor T cell products clinical research
  • T/CAAM 0003-2022 Privacy Protection and Informed Consent Specifications for Clinical Research of Traditional Chinese Medicine in the Real World
  • T/CAAM 0008-2020 Technical specification for compilation of electronic medical record template for real-world acupuncture and moxibustion clinical research
  • T/CHAS 10-2-26-2020 Quality and safety management of Chinese hospital—— Part 2-26:Patient service—Clinical research
  • T/CAAM 0010-2020 Specifications for recording data of equipment used in real-world acupuncture and moxibustion clinical research
  • T/CAAM 0011-2020 Specifications for use record sheets of various instruments and equipment used in real-world acupuncture and moxibustion clinical research
  • T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
  • T/CACM 015.4-2017 Formulation of standard operating procedures for electronic data collection and management of clinical research on traditional Chinese medicine

Korean Agency for Technology and Standards (KATS), Frontier Clinical Research

VN-TCVN, Frontier Clinical Research

  • TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans
  • TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements

European Committee for Standardization (CEN), Frontier Clinical Research

  • EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
  • prEN 540-1992 Clinical investigation of medical devices for human subjects
  • EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003
  • prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • EN ISO 81060-3:2023 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
  • prEN ISO 11980 rev Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
  • EN 13503-7:2001 Ophthalmic Implants - Itraocular Lenses - Part 7: Clinical Investigations ISO 11979-7:2001, Modified
  • prEN ISO 81060-3:2021 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO/DIS 81060-3:2021)

国家药监局, Frontier Clinical Research

  • YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
  • YY/T 1754.2-2020 Medical Device Preclinical Animal Studies Part 2: Induced Diabetic Rat Skin Defect Model

ES-UNE, Frontier Clinical Research

  • UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • UNE-EN ISO 81060-2:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
  • UNE-EN ISO 81060-2:2020/A1:2021 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
  • UNE-EN ISO 81060-3:2023 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)

KR-KS, Frontier Clinical Research

  • KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
  • KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

US-HHS, Frontier Clinical Research

US-FCR, Frontier Clinical Research

British Standards Institution (BSI), Frontier Clinical Research

  • BS ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports
  • BS ISO 29943-2:2017 Condoms. Guidance on clinical studies. Female condoms, clinical function studies based on self-reports
  • BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses. Clinical investigations
  • BS EN ISO 11979-7:2006+A1:2012 Ophthalmic implants. Intraocular lenses. Clinical investigations
  • 18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
  • BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS EN ISO 81060-3:2022 Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type
  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS EN ISO 81060-2:2019+A1:2020 Non-invasive sphygmomanometers. Clinical investigation of intermittent automated measurement type
  • BS ISO 81060-2:2010 Non-invasive sphygmomanometers. Clinical validation of automated measurement type
  • BS ISO 81060-2:2013 Non-invasive sphygmomanometers. Clinical investigation of automated measurement type
  • BS ISO 11249:2018 Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies
  • 18/30377771 DC BS ISO 81060-3. Non-invasive sphygmomanometers. Part 3. Clinical investigation of continuous automated measurement type
  • 21/30438039 DC BS EN ISO 81060-3.2. Non-invasive sphygmomanometers. Part 3. Clinical investigation of continuous automated measurement type
  • 19/30408758 DC BS EN ISO 81060-3. Non-invasive sphygmomanometers. Part 3. Clinical investigation of continuous automated measurement type
  • BS EN ISO 11979-7:2018 Ophthalmic implants. Intraocular lenses. Clinical investigations of intraocular lenses for the correction of aphakia
  • 17/30357644 DC BS EN ISO 81060-2. Non-invasive sphygmomanometers. Part 2. Clinical investigation of intermittent automated measurement type
  • 19/30393717 DC BS EN ISO 81060-2 AMD1. Non-invasive sphygmomanometers. Part 2. Clinical investigation of intermittent automated measurement type
  • 19/30397676 DC BS EN ISO 81060-3. Non-invasive sphygmomanometers. Part 3. Clinical investigation of continuous non-invasive automated measurement type

Association Francaise de Normalisation, Frontier Clinical Research

  • NF S99-201:1993 Clinical investigation of medical devices for human subjects.
  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
  • NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
  • NF EN ISO 81060-3:2023 Sphygmomanomètres non invasifs - Partie 3 : investigation clinique pour type à mesurage automatique continu
  • NF S97-101-2*NF EN ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2 : clinical investigation of intermittent automated measurement type
  • NF S97-101-2*NF EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2 : clinical investigation of automated measurement type
  • NF EN ISO 11980:2013 Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques
  • NF EN ISO 81060-2:2019 Sphygmomanomètres non invasifs - Partie 2 : investigation clinique pour type ponctuel à mesurage automatique
  • NF S97-101-2/A1*NF EN ISO 81060-2/A1:2020 Non-invasive sphygmomanometers - Part 2 : clinical investigation of intermittent automated measurement type - Amendment 1

未注明发布机构, Frontier Clinical Research

International Organization for Standardization (ISO), Frontier Clinical Research

  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports
  • ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
  • ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
  • ISO 81060-3:2022 Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
  • ISO 11249:2018 Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies
  • ISO 81060-2:2018/DAmd 2 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2
  • ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
  • ISO 81060-2:2018/FDAmd 2:2011 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2

German Institute for Standardization, Frontier Clinical Research

  • DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
  • DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
  • DIN EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
  • DIN EN ISO 11979-7:2012 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006 + Amd 1:2012); German version EN ISO 11979-7:2006 + A1:2012
  • DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
  • DIN EN ISO 81060-2:2020-12 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018 + Amd 1:2020); German version EN ISO 81060-2:2019 + A1:2020
  • DIN EN ISO 11980:2013-03 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012
  • DIN EN ISO 81060-3:2020 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO/DIS 81060-3:2019); German and English version prEN ISO 81060-3:2019

NL-NEN, Frontier Clinical Research

  • NEN-EN 540-1994 Clinical investigation of medical devices for human subjects

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Frontier Clinical Research

  • GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports

PT-IPQ, Frontier Clinical Research

  • NP EN 540-2001 Clinical investigation of medical devices for human subjects

Danish Standards Foundation, Frontier Clinical Research

  • DS/EN 540:1993 Clinical investigation of medical devices for human subjects
  • DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
  • DS/EN ISO 11979-7/A1:2012 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations
  • DS/EN ISO 11979-7:2006 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations
  • DS/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type
  • DS/EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

Beijing Provincial Standard of the People's Republic of China, Frontier Clinical Research

Shanghai Provincial Standard of the People's Republic of China, Frontier Clinical Research

US-AAMI, Frontier Clinical Research

IT-UNI, Frontier Clinical Research

RU-GOST R, Frontier Clinical Research

  • GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
  • GOST R 52999.3-2009 Cardiac valve prostheses. Part 3. Guidance on clinical investigation
  • GOST 31618.3-2012 Cardiac valve prostheses. Part 3. Guidance on clinical investigation
  • GOST 31580.7-2012 Ophthalmic implants. Intraocular lenses. Part 7. Clinical investigations
  • 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 56702-2015 Medicines for medical applications. Nonclinical toxicology and pharmacokinetic studies of safety
  • GOST R 55041-2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations

AT-ON, Frontier Clinical Research

  • OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • OENORM EN ISO 81060-3:2021 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO/DIS 81060-3:2021)

Lithuanian Standards Office , Frontier Clinical Research

  • LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • LST EN ISO 11979-7:2006 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
  • LST EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

PL-PKN, Frontier Clinical Research

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

AENOR, Frontier Clinical Research

  • UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • UNE-EN ISO 11979-7:2015 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
  • UNE-EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
  • UNE-EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

American National Standards Institute (ANSI), Frontier Clinical Research

Canadian General Standards Board (CGSB), Frontier Clinical Research

IX-EU/EC, Frontier Clinical Research

  • MEDDEV 2.7/4-2010 GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
  • MEDDEV 2.7.2-2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
  • MEDDEV 2.12/2-2012 POST MARKET CLINICAL FOLLOW-UP STUDIES A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (REV 2)

National Health Commission of the People's Republic of China, Frontier Clinical Research

Canadian Standards Association (CSA), Frontier Clinical Research

  • CAN/CSA-ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (First Edition)

Standard Association of Australia (SAA), Frontier Clinical Research

  • ISO 81060-2:2018/AMD1:2020 Amendment 1 — Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

International Electrotechnical Commission (IEC), Frontier Clinical Research

  • ISO 81060-2:2018 Amendment 1 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

API - American Petroleum Institute, Frontier Clinical Research

  • API PUBL 32-32502-1982 A UNIFIED APPROACH TO THE USE OF HUMAN CLINICAL DATA: CASE STUDY OF NITROGEN DIOXIDE AND SULFUR DIOXIDE

Professional Standard - Medicine, Frontier Clinical Research

  • YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties




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