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Phase I clinical trial

Phase I clinical trial, Total:115 items.

In the international standard classification, Phase I clinical trial involves: Medical sciences and health care facilities in general, Quality, Medical equipment, Pharmaceutics, Test conditions and procedures in general, Dentistry, Laboratory medicine, Applications of information technology, Birth control. Mechanical contraceptives, Veterinary medicine, Terminology (principles and coordination), Machine tools, Construction equipment.

Group Standards of the People's Republic of China, Phase I clinical trial

T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
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 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
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 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
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/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
T/CGCPU 016-2021 Technical requirements for clinical trials of new drugs for oral inhalation of respiratory system in pediatric populations
T/CACM 1351-2021 Standards for collection, preservation and transportation of fecal microbial samples in clinical trials of TCM

RU-GOST R, Phase I clinical trial

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 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 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 8-1982 Metal cutting machine tools. General requirements to accuracy tests
GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
GOST 28541-1995 Stone-sawing machines. General technical requirements and test methods
GOST 28541-1990 Stone-sawing machines. General technical requirements and test methods

Professional Standard - Agriculture, Phase I clinical trial

农业部1247号公告-4-2009 Guiding Principles for Phase II and Phase III Clinical Drug Efficacy Evaluation Trials of Antibacterial Drugs
农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs
农业部1596号公告-1-2011 Technical guidelines for clinical trials of traditional Chinese medicines and natural medicines for veterinary use
农业部1247号公告-3-2009 Guiding principles for clinical pharmacokinetic tests of veterinary chemical drugs
农业部1596号公告-2-2011 Writing principles of clinical trial reports of traditional Chinese medicine and natural medicine for veterinary use
农业部1247号公告-2-2009 Guiding principles for non-clinical pharmacokinetic tests of veterinary chemical drugs

American Society for Testing and Materials (ASTM), Phase I clinical trial

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 F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
ASTM E2045-22 Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-99(2014) Standard Practice for Detailed Clinical Observations of Test Animals

Professional Standard - Medicine, Phase I clinical trial

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 0990-2015 Clinical trial guideline for polymer-based dental restorative materials
YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods

US-AAMI, Phase I clinical trial

ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice

Danish Standards Foundation, Phase I clinical trial

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

IT-UNI, Phase I clinical trial

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

Association Francaise de Normalisation, Phase I clinical trial

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S94-801:2007 Vaginal reinforcement implant for stress urinary incontinence and/or pelvic organ prolapse repair surgery through vaginal approach - Pre-clinical and clinical tests.
NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques
NF C20-428:1981 Provisional Requirements Tests Methods Basic Environmental Testing Procedures General Considerations on Ultrasonic Cleaning
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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Phase I clinical trial

GB/T 30224-2013 Clinical use of tests for Toxoplasma gondii

卫生健康委员会, Phase I clinical trial

WS/T 574-2018 Purified water for clinical laboratory reagents

British Standards Institution (BSI), Phase I clinical trial

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
BS 3800-3:1990 General tests for machine tools - Method of testing performance of machines operating under loaded conditions in respect of thermal distortion

European Committee for Standardization (CEN), Phase I clinical trial

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)

AT-ON, Phase I clinical trial

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

Lithuanian Standards Office , Phase I clinical trial

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

PL-PKN, Phase I clinical trial

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

AENOR, Phase I clinical trial

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

German Institute for Standardization, Phase I clinical trial

DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 8596:2020-05 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO 8596:2017 + Amd.1:2019); German version EN ISO 8596:2018 + A1:2020
DIN 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

Zhejiang Provincial Standard of the People's Republic of China, Phase I clinical trial

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

American National Standards Institute （ANSI), Phase I clinical trial

ANSI/HL7 V3 PORT, R 1-2004 HL7 Version 3 Standard: Regulated Studies - Periodic Reporting of Clinical Trials Laboratory Results, , Release 1

ZA-SANS, Phase I clinical trial

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

Korean Agency for Technology and Standards (KATS), Phase I clinical trial

KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO TS 22911:2010 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
KS P ISO TS 22911:2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P ISO TS 16782:2018 Clinical laboratory testing ─ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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

Canadian General Standards Board （CGSB), Phase I clinical trial

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials
CGSB 191.1-2013-CAN/CGSB-2013 Surveillance de l掗thique de recherches comportant des essais cliniques biom閐icaux

Hunan Provincial Standard of the People's Republic of China, Phase I clinical trial

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

International Organization for Standardization (ISO), Phase I clinical trial

ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1
ISO 8596:2017/Amd 1:2019 Ophthalmic optics — Visual acuity testing — Standard and clinical optotypes and their presentation — Amendment 1
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

中华人民共和国国家卫生和计划生育委员会, Phase I clinical trial

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline

Professional Standard - Hygiene , Phase I clinical trial

WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

KR-KS, Phase I clinical trial

KS M ISO 16037-2018 Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P ISO TS 16782-2018 Clinical laboratory testing ─ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Japanese Industrial Standards Committee (JISC), Phase I clinical trial

JIS B 6201:1993 Machine tools -- Running tests and rigidity tests -- General requirements
JIS T 6001:2005 Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials

NO-SN, Phase I clinical trial

NS 5026-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy
NS 5025-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy - General introduction

国家市场监督管理总局、中国国家标准化管理委员会, Phase I clinical trial

GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

IN-BIS, Phase I clinical trial

IS 10352-1992 Test charts for internal cylindrical grinding machines with horizontal spindle (First Revision)

Canadian Standards Association (CSA), Phase I clinical trial

CSA C22.2 No.73-1953-1953 Construction and Test of Electrically Equipped Machine Tools General Instruction No 1