First in clinical trials

First in clinical trials, Total:108 items.

The international standard classification for "First in clinical trials" includes: Dental materials , Medical Sciences and health care facilities in general , Laboratory medicine .

The Chinese standard classification for "First in clinical trials" includes: Stomatologic device, equipment and material , Sanitation in general , Codification , Legal medical expert .

Group Standards of the People's Republic of China

T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
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/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
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 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria

Professional Standard - Medicine

YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials
YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant

卫生健康委员会

WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 662-2020 Technical requirements for clinical body fluids analysis

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii

Professional Standard - Hygiene

WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 102-1998 Classification and codes of clinical laboratory tests item

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 1333-2023 Integrated clinical information system functional guide
DB33/T 903-2013 Classification and coding of clinical laboratory test items

司法部

SF/T 0111-2021 Specification of examination in forensic clinical medicine

Professional Standard - Certification and Accreditation

RB/T 192-2015 Guideline for clinical forensic examination
RB/T192-2015 Forensic Clinical Examination Standards

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

中华人民共和国国家卫生和计划生育委员会

WS/T 496-2017 Quality indicators in clinical laboratories
WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline

Professional Standard - Agriculture

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs

RU-GOST R

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 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 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 53079.3-2008 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 57525-2017 Clinical and economic analysis. General requirements
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
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 ISO 14155-2014 Clinical investigation. Good clinical practice
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

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 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements
GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation

GSO

BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device

American Society for Testing and Materials (ASTM)

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

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF S91-001-1:1992 Dental vocabulary. Part 1 : general and clinical terms.

US-AAMI

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

IT-UNI

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

Danish Standards Foundation

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

European Committee for Standardization (CEN)

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 ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003

British Standards Institution (BSI)

BS EN ISO 14155:2011 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

PL-PKN

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

AT-ON

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ONORM EN 21942-1-1992 Dental vocabulary - General and clinical terms

Lithuanian Standards Office

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

German Institute for Standardization

DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN 14822-3:2006 Health informatics - General purpose information components - Part 3: Clinical; English version EN 14822-3:2005

AENOR

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

International Organization for Standardization (ISO)

ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 1942-1:1977 Dental vocabulary. Part 1: General and clinical terminology
ISO 1942-1:1975 Dental vocabulary. Part 1: General and clinical terminology
ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties

ZA-SANS

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

KR-KS

KS P ISO 1942-1-2010 Dental vocabulary－Part 1：General and clinical terms
KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties

SCC

NS-ISO 1942-1:1989 Dental vocabulary — Part 1: General and clinical terms
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing

Canadian General Standards Board （CGSB)

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials
CGSB 191.1-2013-CAN/CGSB-2013 Oversight of research ethics involving biomedical clinical trials

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories

US-CLSI

CLSI GP17-A3-2012 Clinical Laboratory Safety; Approved Guideline - Third Edition