Clinical Trials

Clinical Trials, Total:50 items.

The international standard classification for "Clinical Trials" includes: Dental materials .

The Chinese standard classification for "Clinical Trials" includes: Stomatologic device, equipment and material .

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

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
DB43/T 2896-2023 Standards for the construction and operation management of practical training bases for principal investigators in drug clinical trials

Group Standards of the People's Republic of China

T/CACM 1333.3-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric common diseases Part 3: Functional abdominal pain
T/CACM 1333.1-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 1: Anorexia
T/SHQAP 016-2024 Drug clinical trial management system — Dataset specification
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CACM 1351-2021 Standards for collection, preservation and transportation of fecal microbial samples in clinical trials of TCM
T/SSFSIDC 015-2023 Clinical trial data collection requirements
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/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 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
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 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CACM 1333.4-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric series of common diseases Part 4: Diarrhea in children
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CACM 1333.2-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 2: functional constipation

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4652-2024 Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology

GOST

GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans

RU-GOST R

GOST R 52379-2005 Good clinical practice (GCP)

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

South African Bureau of Standard

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

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

Association Francaise de Normalisation

NF S99-201*NF 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

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