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Phase 3 clinical trial
Phase 3 clinical trial, Total:99 items.
In the international standard classification, Phase 3 clinical trial involves: Medical sciences and health care facilities in general, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Applications of information technology, Laboratory medicine, Hospital equipment, Veterinary medicine, Medical equipment, Pharmaceutics, Test conditions and procedures in general, Construction materials, Thermodynamics and temperature measurements, Quality.
RU-GOST R, Phase 3 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 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 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 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 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
- 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 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 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
Professional Standard - Hygiene , Phase 3 clinical trial
- WS/T 251-2005 Guidelines for Clinical Laboratory Safety
- WS/T 442-2014 Guideline for clinical laboratory biosafety
- WS/T 249-2005 Clinical Laboratory Waste Management
- 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
- WS/T 489-2016 Clinical microbiological laboratory diagnosis of urinary tract infection;
- WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
- WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
- WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
- WS/T 404.3-2012 Reference intervals for common clinical biochemistry tests.Part 3:Serum potassium,sodium and chloride
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Phase 3 clinical trial
- GB/T 20469-2006 General guideline of the clinical laboratory design
- GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
- GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory
中华人民共和国国家卫生和计划生育委员会, Phase 3 clinical trial
- WS/T 496-2017 Quality indicators in clinical laboratories
- WS/T 498-2017 Performance guideline for clinical laboratory diagnosis of bacterial diarrhea
- WS/T 497-2017 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases
American National Standards Institute （ANSI), Phase 3 clinical trial
- ANSI/HL7 V3 PORT, R 1-2004 HL7 Version 3 Standard: Regulated Studies - Periodic Reporting of Clinical Trials Laboratory Results, , Release 1
Group Standards of the People's Republic of China, Phase 3 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/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
- T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Phase 3 clinical trial
AENOR, Phase 3 clinical trial
卫生健康委员会, Phase 3 clinical trial
- WS/T 574-2018 Purified water for clinical laboratory reagents
- WS/T 616-2018 Automated review of quantitative test results in clinical laboratories
US-HHS, Phase 3 clinical trial
Zhejiang Provincial Standard of the People's Republic of China, Phase 3 clinical trial
- DB33/T 893.3-2013 Clinical Laboratory Information System Part 3: Workflow Specification
- DB33/T 903-2013 Classification and coding of clinical laboratory test items
- DB33/T 893.1-2013 Clinical Laboratory Information System Part 1: Basic Functional Specifications
- DB33/T 893.2-2013 Clinical Laboratory Information System Part 2: Data Transmission and Exchange
司法部, Phase 3 clinical trial
- SF/T 0112-2021 Standards for implementation of forensic clinical imaging examinations
US-CLSI, Phase 3 clinical trial
- CLSI GP17-A3-2012 Clinical Laboratory Safety; Approved Guideline - Third Edition
- CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory
- CLSI MM19-A-2011 Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline
US-FCR, Phase 3 clinical trial
American Society for Testing and Materials (ASTM), Phase 3 clinical trial
- 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 E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
- ASTM E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
- ASTM E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System
- ASTM E792-02 Standard Guide for Selection of a Clinical Laboratory Information Management System
- ASTM E1246-88(1995) Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
- ASTM E1029-84(1997) Standard Guide for Documentation of Clinical Laboratory Computer Systems
- ASTM E1639-97 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
- ASTM E1029-01 Standard Guide for Documentation of Clinical Laboratory Computer Systems
- ASTM E102-93(1997) Standard Test Method for Saybolt Furol Viscosity of Bituminous Materials at High Temperatures
- ASTM E1639-01 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
- ASTM E1246-01 Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
- ASTM E879-01(2007) Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
- 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
- ASTM E879-01 Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
- ASTM E879-93 Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
- ASTM E1381-95 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
- ASTM E2210-12 Standard Specification for Guideline Elements Model version 3 (GEM III)mdash;Document Model for Clinical Practice Guidelines
- ASTM E1381-02 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
国家卫生计生委, Phase 3 clinical trial
- WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories
Korean Agency for Technology and Standards (KATS), Phase 3 clinical trial
- KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance
- KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
- KS P 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
- KS X ISO 18812-2016(2021) Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
- KS P ISO 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
- KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
- 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 TR 18112:2009 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
Professional Standard - Agriculture, Phase 3 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
British Standards Institution (BSI), Phase 3 clinical trial
- DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
- DD ENV 1614-1995 Healthcare informatics. Structure for nomenclature, classification and coding of properties in clinical laboratory science
- BS PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Guangdong Provincial Standard of the People's Republic of China, Phase 3 clinical trial
- DB44/T 2428-2023 Automatic review rules for quantitative biochemical test results in clinical laboratories of traditional Chinese medicine hospitals
Association Francaise de Normalisation, Phase 3 clinical trial
- NF EN ISO 18812:2003 Informatique de santé - Interfaces d'analyseur clinique pour systèmes d'information de laboratoire - Profils d'utilisation
- 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 EN ISO 7787-3:2017 Médecine bucco-dentaire - Fraises de laboratoire - Partie 3 : fraises de laboratoire en carbure pour machines à fraiser
GM Global, Phase 3 clinical trial
CN-GJB-H, Phase 3 clinical trial
- GJB 7125.3-2011 Model selection technique requirements for military medical equipments.Part 3:Clinical laboratory equipments
国家市场监督管理总局、中国国家标准化管理委员会, Phase 3 clinical trial
- GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
- GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination
- GB/T 22576.2-2021 Medical laboratories—Requirements for quality and competence—Part 2: Requirements in the field of clinical hematological examination
- GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5: Requirements in the field of clinical immunology examination
- GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination
International Organization for Standardization (ISO), Phase 3 clinical trial
- ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
German Institute for Standardization, Phase 3 clinical trial
- DIN 58937-7:1994 General laboratory medicine (clinical pathology); part 7: listing of features of in vitro diagnostic systems
- DIN EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use of profiles (ISO 18812:2003); German version EN ISO 18812:2003, text in English
KR-KS, Phase 3 clinical trial
- KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
- 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 X ISO 18812-2016 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
- KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
国家市场监督管理总局, Phase 3 clinical trial
- RB/T 060.2-2021 Forensic Identification/Forensic Science Proficiency Testing Implementation Guide Part 2: Forensic Clinical Identification
European Committee for Standardization (CEN), Phase 3 clinical trial
- DD ENV 13728-2000 Health Informatics - Clinical Analyser Interfaces to Laboratory Information Systems Ratified European Text