Phase I Clinical Trial Design
Phase I Clinical Trial Design, Total:44 items.
The international standard classification for "Phase I Clinical Trial Design" includes: Laboratory medicine , Dental materials , Medical Sciences and health care facilities in general .
The Chinese standard classification for "Phase I Clinical Trial Design" includes: Sanitation in general , Stomatologic device, equipment and material .
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
Group Standards of the People's Republic of China
- T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
- T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
- T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
- T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
- T/SSFSIDC 015-2023 Clinical trial data collection requirements
- 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/CGCPU 026-2023 Design specifications for clinical trial protocol of cardiovascular interventional medical devices
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
Professional Standard - Agriculture
- 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
Professional Standard - Medicine
- YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
卫生健康委员会
- WS/T 574-2018 Purified reagent water in the clinical laboratory
Professional Standard - Hygiene
- WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
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
GSO
- BH GSO ASTM F3037:2022 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
- GSO ASTM F3037:2021 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
- 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
American Society for Testing and Materials (ASTM)
- ASTM F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
- 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
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)
International Organization for Standardization (ISO)
- ISO/CD 12487:2023 Medical electrical equipment — Clinical investigation of clinical thermometers
- ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
British Standards Institution (BSI)
- BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
- BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
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 14155:2011 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
Military Standards (MIL-STD)
- DOD A-A-54898-1993 THERMOMETER, LIQUID CRYSTAL, CLINICAL, DISPOSABLE
- DOD A-A-51827-1987 THERMOMETER, CLINICAL, HUMAN, (DISPOSABLE)
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)
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
SCC
- AS CS 10.4.1:1938 Equipment and supplies for use in public institutions - Clinical thermometers
- AS CS 10.4.1:1933 Equipment and supplies for use in public institutions - Clinical thermometers
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