Product Clinical Trials

Product Clinical Trials, Total:102 items.

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

The Chinese standard classification for "Product Clinical Trials" includes: Stomatologic device, equipment and material , Sanitation in general , Legal medical expert .

Group Standards of the People's Republic of China

T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/JPMA 023-2024 Specification for safety follow-up of vaccine clinical trials
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CMEAS 032-2024 Drug management standards during clinical research of stem cell products
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
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/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/SHQAP 016-2024 Drug clinical trial management system — Dataset specification
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 5140-2025 Specifications for the Management of Medicinal Products Used in Clinical Trials
DB32/T 4975-2024 Bioethical Management Requirements for Clinical Trial Biological Samples
DB32/T 4904-2024 Vaccines clinical trial site management standards

Professional Standard - Medicine

YY/T 1956-2025 Terms and definitions for clinical trials of in vitro diagnostic reagents
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant

Professional Standard - Hygiene

WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 251-2005 Guidelines for Clinical Laboratory Safety

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

Zhejiang Provincial Standard of the People's Republic of China

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

Guangdong Provincial Standard of the People's Republic of China

DB44/T 2551-2024 Standards for the construction and management of drug clinical trial institutions
DB44/T 2552-2024 Ethical review standards for drug clinical trials

未注明发布机构

CLSI EP37-2018 Supplemental Tables for Interference Testing in Clinical Chemistry
CLSI GP05-A3-2011 Clinical Laboratory Waste Management; Approved Guideline—Third Edition
CLSI GP40-A4-AMD-2012 Preparation and testing of reagent water for clinical laboratories

Professional Standard - Judicatory

SF/Z JD0103003-2011 Specifications for Forensic Clinical Examination
SF/T 0111-2021 Specification of examination in forensic clinical medicine

Professional Standard - Certification and Accreditation

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

Professional Standard - Earthquake

DB 32/T 4975-2024 Ethical Management Requirements for Biological Samples in Clinical Trials

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

Gosstandart of Russia

GOST R 56429-2021 Medical devices. Clinical еvaluation
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 ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 52379-2005 Good clinical practice (GCP)
GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
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

British Standards Institution (BSI)

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN 13398:2003 Methods of test for petroleum and its products - BS 2000-516:Bitumen and bituminous binders - Determination of the elastic recovery of modified bitumen
BS EN 13374:2004 Temporary edge protection systems - Product specification, test methods
BS EN 13374:2013+A1:2018(2021) Temporary edge protection systems. Product specification. Test methods
BS EN 13374:2013 Temporary edge protection systems. Product specification. Test methods
BS EN 13399:2003 Methods of test for petroleum and its products - BS 2000-517:Bitumen and bituminous binders - Determination of storage stability of modified bitumen
BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN 13375:2004 Flexible sheets for waterproofing-Waterproofing of concrete bridge decks and other concrete surfaces trafficable by vehicles-Specimen preparation

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 13374:2013 Temporary edge protection systems - Product specification - Test methods

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

GCC Standardization Organization

GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

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 E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF P93-400:2013 Temporary edge protection systems - Product specification - Test methods

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
DANSK DS/EN 13374+A1:2019 Temporary edge protection systems – Product specification – Test methods

IT-UNI

EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

PL-PKN

PN-EN ISO 14155-2021-02 E 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)

German Institute for Standardization

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

Spanish Association for Standardization (UNE)

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

South African Bureau of Standard

f_6903 Checklist for Good Clinical Practice
SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties

Canadian General Standards Board （CGSB)

CAN/CGSB 191.1-2013 Ethical Supervision of Biomedical Clinical Trials
CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials

Ente Nazionale Italiano di Unificazione

EC 1-2007 UNI EN 13374:2004 Temporary edge protection systems - Product specification, test methods
UNI EN 13374:2004 Temporary edge protection systems - Product specification, test methods
UNI EN 13374:2013 Temporary edge protection systems - Product specification - Test methods
UNI EN 13374:2019 Temporary edge protection systems - Product specification - Test methods

Standards Norway

NS-EN 13374:2013+A1:2018 Temporary edge protection systems — Product specification — Test methods

Swedish Institute for Standards

SS-EN 13374:2013+A1:2019 Temporary edge protection systems - Product specification - Test methods
SS-EN 13374:2013 Temporary edge protection systems - Product specification - Test methods

CEN - European Committee for Standardization

EN 13374:2004 Temporary edge protection systems Product specification@ test methods

Others: Clinical Trials,Clinical Trial Testing,Analyzing Clinical Trials,clinical trial quality,drug clinical trial,Clinical Trial Pre-Trial,Clinical Trial Equipment,Product Clinical Trials,clinical trial design,Clinical Nutrition Products,clinical trial results,Clinical Trial System,medical clinical trial,Clinical Trial Report,Clinical Trial Review,Product clinical,clinical product,clinical product,Clinical + Trial