Gold Standard for Clinical Trials

Gold Standard for Clinical Trials, Total:143 items.

The international standard classification for "Gold Standard for Clinical Trials" includes: Dental materials , Medical Sciences and health care facilities in general , Laboratory medicine .

The Chinese standard classification for "Gold Standard for Clinical Trials" includes: Stomatologic device, equipment and material , Sanitation in general , Medical laboratory equipment , Codification , Legal medical expert .

Professional Standard - Medicine

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

Group Standards of the People's Republic of China

T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CAMDI 037-2020 3D printing tantalum metal clinical application standard
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/SHSPS 001-2024 Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai)
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 012-2020 File management standards for clinical trial institutions
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/SHSPS 002-2024 Standards for the management and competency evaluation of clinical trial monitors (Shanghai)
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CAQI 366-2024 Clinical testing quantitative project method confirmation
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CAV 009-2024 Quality control standards for on-site implementation of vaccine clinical trials
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
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/CHSA 005-2020 Clinical guidelines for restoration of tooth defects with gold alloys
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
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/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions

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
WS/T 804-2022 Basic technical standard for clinical chemistry laboratory

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

GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

Professional Standard - Hygiene

WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
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 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 102-1998 Classification and codes of clinical laboratory tests item
WS/T 249-2005 Clinical Laboratory Waste Management

Zhejiang Provincial Standard of the People's Republic of China

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 227-2002 Requirement for the technical procedure manual in clinical laboratory
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

Professional Standard - Agriculture

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-4-2009 Guiding Principles for Phase II and Phase III Clinical Drug Efficacy Evaluation Trials of Antibacterial Drugs

Hunan Provincial Standard of the People's Republic of China

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

Anhui Provincial Standard of the People's Republic of China

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

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 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 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 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 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)

GSO

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
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 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
BH GSO ASTM F3037:2022 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties

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

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
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)

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

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

US-AAMI

ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice
ANSI/AAMI/ISO 14155:2011 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
DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties

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
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice

European Committee for Standardization (CEN)

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)

PL-PKN

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

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

Lithuanian Standards Office

LST EN ISO 14155:2020 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)

AENOR

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.

Military Standards (MIL-STD)

DOD A-A-54861-1993 INDICATOR, CLINICAL CHART HOLDER, METAL
DOD A-A-51709-1986 THERMOMETER, CLINICAL, HUMAN

ZA-SANS

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

US-FCR

FCR 21 CFR PART 862-2014 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2013 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2015 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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

Korean Agency for Technology and Standards (KATS)

KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
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 M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties

SCC

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
CAN/HSO 1003:2023 Clinical Governance
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice

KR-KS

KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice

International Organization for Standardization (ISO)

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 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice

BE-NBN

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

ES-UNE

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