Phase IV of clinical trials

Phase IV of clinical trials, Total:43 items.

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

The Chinese standard classification for "Phase IV of clinical trials" includes: Stomatologic device, equipment and material , Sanitation in general .

Group Standards of the People's Republic of China

T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CACM 1306-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM the wind of four fossae
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
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 014-2020 The practices of chemicals for clinical trials in clinical trial institutions

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

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

Professional Standard - Hygiene

WS/T 834-2024 Clinical application 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

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

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

GOST

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

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

Association Francaise de Normalisation

NF S99-201*NF EN 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

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

British Standards Institution (BSI)

BS EN ISO 14155:2011 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)

AT-ON

OENORM EN ISO 14155:2021 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)

German Institute for Standardization

DIN EN ISO 14155:2020 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)