Preclinical and Clinical Research

Preclinical and Clinical Research, Total:166 items.

The international standard classification for "Preclinical and Clinical Research" includes: Research and development , Medical Sciences and health care facilities in general , Medical equipment in general , Birth control. Mechanical contraceptives .

The Chinese standard classification for "Preclinical and Clinical Research" includes: Standardization and quality management , Medical science , Medical apparatus and devices in general , Other special devices .

Group Standards of the People's Republic of China

T/SDXG 06-2024 Guidelines for the Construction of Clinical Research Centers in Medical and Health Institutions
T/CAAM 0002-2022 Acupuncture and moxibustion clinical research adverse event recording specification
T/GDPHA 005-2021 Data Element Standard for Clinical Scientific Research of Cerebral Hemorrhage
T/CMBA 022-2024 Construction and management specification for developing clinical research unit
T/GDPHA 011-2021 Data Element Standard for Clinical Scientific Research of Anxiety Disorder
T/GDPHA 020-2021 Data Element Standard for Clinical Scientific Research of Mammary cancer
T/ZJPA 002-2024 Clinical Research Coordinator (CRC) Training Requirement
T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
T/CACM 1323-2019 Standard operating procedure for Chinese medicine data monitoring committee of clinical studies
T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
T/CGCPU 017-2021 Quality control requirements for clinical research of CAR-T cell products
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CAAM 0009-2022 Data management specification for real-world acupuncture and moxibustion clinical research
T/GDPHA 003-2021 Data Element Standard for Clinical Scientific Research of Coronary Heart Disease
T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 015.11-2017 Formulation of technical specifications for the summary report of clinical research of traditional Chinese medicine
T/GDPHA 017-2021 Data Element Standard for Clinical Scientific Research of Esophageal Cancer
T/GDPHA 012-2021 Data Element Standard for Clinical Scientific Research of Diabetes
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CACM 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
T/GDPHA 015-2021 Data Element Standard for Clinical Scientific Research of Live Cancer
T/CAAM 0012-2020 Data acquisition specification in clinical trials of acupuncture and moxibustion in the real world
T/GDPHA 004-2021 Data Element Standard for Clinical Scientific Research of Cerebral Infarction
T/CAAM 0005-2022 General rules for the compilation of real-world acupuncture and moxibustion clinical research norms
T/CGCPU 001-2023 Specification for capacity evaluation of clinical trial coordinator
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/GDPHA 006-2021 Data Element Standard for Clinical Scientific Research of Autism
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/ZJPA 001-2024 Requirements for Clinical Research Coordinator (CRC) professional ability
T/CGDF 00042-2024 Standard for allergic diseases clinical research base construction
T/GDPHA 008-2021 Data Element Standard for Clinical Scientific Research of Depression
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
T/CGCPU 001-2015 Guidance for clinical research coordinator profession practice
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/GDPHA 028-2021 Standard Data Set of Clinical Research on Malignant Tumor Diseases
T/CRHA 066-2024 Meta data model and data quality evaluation specification for clinical research of lymphoma
T/GDPHA 029-2021 Standard Data Set of Clinical Research on Diabetes
T/GDPHA 014-2021 Data Element Standard for Clinical Scientific Research of Lung Cancer
T/GDPHA 019-2021 Data Element Standard for Clinical Scientific Research of Pancreatic Cancer
T/GDPHA 016-2021 Data Element Standard for Clinical Scientific Research of Gastric Cancer
T/GDPHA 002-2021 Data Element Standard for Clinical Scientific Research of Hypertension
T/CRHA 067-2024 The guidelines of clinical research telephone-based follow-up
T/CACM 015.9-2017 Technical specification for the management of clinical research results of traditional Chinese medicine

Beijing Provincial Standard of the People's Republic of China

DB11/T 2226-2024 Clinical research data collection and application specifications
DB11/T 2026-2022 Specialized Clinical Research Data Element Mental Disorders

世界针灸学会联合会World Federation of Acupuncture-Moxibustion Societies

WFAS 009.1-2023 Acupuncture clinical research management standards

Professional Standard - Medicine

YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations

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

GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1440-2023 Clinical Research Center Construction and Management Standards

Shanxi Provincial Standard of the People's Republic of China

DB14/T 3565-2025 Requirements for the Ethical Management of Clinical Research in Healthcare Institutions

British Standards Institution (BSI)

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice
24/30467406 DC BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
BS ISO 29943-2:2017 Condoms. Guidance on clinical studies. Female condoms, clinical function studies based on self-reports
BS ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
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
BS EN ISO 11979-7:2006+A1:2012 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS EN 540:1993 Clinical investigation of medical devices for human subjects
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 81060-2:2014 Non-invasive sphygmomanometers-Clinical investigation of automated measurement type
BS EN ISO 11979-7:2006 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
BS EN ISO 81060-3:2022 Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type
BS EN ISO 81060-2:2019+A2:2024 Non-invasive sphygmomanometers - Clinical investigation of intermittent automated measurement type

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects － Part 2: Clinical investigation plans
KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice

Gosstandart of Russia

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 52999.3-2009 Cardiac valve prostheses. Part 3. Guidance on clinical investigation
GOST 31618.3-2012 Cardiac valve prostheses. Part 3. Guidance on clinical investigation
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

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

Bureau of Indian Standards

IS/ISO 14155-2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice
IS/ISO 29943-2-2017 Condoms Guidance on clinical studies Part 2: Female condoms clinical function studies based on self-reports
IS/ISO 29943-1-2017 Condoms Guidance on clinical studies Part 1: Male condoms clinical function studies based on self-reports

Association for the Advancement of Medical Instrumentation

AAMI/ISO 14155-2:2003(R2008) Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans
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
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice
AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

International Organization for Standardization (ISO)

ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports

Standard Association of Australia （SAA）

AS ISO 14155:2002 Clinical investigation of medical devices

Danish Standards Foundation

DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/EN 540:1993 Clinical investigation of medical devices for human subjects

Spanish Association for Standardization (UNE)

UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

European Committee for Standardization (CEN)

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
prEN 540-1992 Clinical investigation of medical devices for human subjects
prEN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
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)

German Institute for Standardization

DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
DIN EN ISO 14155:2020-12 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 14155:2024 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 14155 E:2024-09 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155:2018-08 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
DIN EN ISO 14155-2:2009-11 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DIN EN ISO 14155 E:2018 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
DIN EN ISO 14155-2:2003-09 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 14155/A11:2025-03 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020/A11:2024
DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
DIN EN ISO 14155:2012-01 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011)

Standards Norway

NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
NS-EN 540:1993 Clinical investigation of medical devices for human subjects

Ente Nazionale Italiano di Unificazione

EC 1-2011 UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2025 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
UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN 13503-7:2002 Ophthalmic implants - Intraocular lenses - Clinical investigations
UNI EN ISO 11980:1998 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 54-2014 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2013 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2015 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR FED H-08-3 316-1-1988 RESEARCH AND CLINICAL LABORATORY GAS AND VACUUM SYSTEMS

United States Department of Health and Human Services

HHS 21 CFR PART 54 CFR PART 54-2011 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
HHS 21 CFR PART 58-2011 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S99-201:1993 Clinical investigation of medical devices for human subjects.
NF S99-201/A11*NF EN ISO 14155/A11:2024 Clinical investigation of medical devices for human subjects - Good clinical practice

Swedish Institute for Standards

SS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
SS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

GCC Standardization Organization

GSO ISO 29943-1:2021 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
GSO ISO 29943-2:2021 Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
GSO ISO 11979-7:2014 Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical investigations

Canadian General Standards Board （CGSB)

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

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 29943-1:2022 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports

Netherlands Institute for Standardization

NEN-EN 540-1994 Clinical investigation of medical devices for human subjects

Lithuanian Standards Office

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

Austrian Standards

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

Polski Komitet Normalizacyjny (PKN)

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

Portuguese Institute of Quality

NP EN 540-2001 Clinical investigation of medical devices for human subjects

American National Standards Institute （ANSI)

ANSI/HL7 EHRCRFP, R 1-2009 HL7 EHR Clinical Research Functional Profile, Release 1

American Society for Testing and Materials (ASTM)

ASTM STP 872-1985 Inhalation Toxicology of Air Pollution: Considerations for Clinical Studies

European Union/Commission

MEDDEV 2.7/4-2010 GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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