Clinical phase II study

Clinical phase II study, Total:146 items.

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

The Chinese standard classification for "Clinical phase II study" includes: Standardization and quality management , Medical science , Other special 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

Group Standards of the People's Republic of China

T/GDPHA 005-2021 Data Element Standard for Clinical Scientific Research of Cerebral Hemorrhage
T/ZJPA 001-2024 Requirements for Clinical Research Coordinator (CRC) professional ability
T/CACM 015.11-2017 Formulation of technical specifications for the summary report of clinical research of traditional Chinese medicine
T/SDXG 06-2024 Guidelines for the Construction of Clinical Research Centers in Medical and Health Institutions
T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
T/GDPHA 017-2021 Data Element Standard for Clinical Scientific Research of Esophageal Cancer
T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CMBA 022-2024 Construction and management specification for developing clinical research unit
T/GDPHA 020-2021 Data Element Standard for Clinical Scientific Research of Mammary cancer
T/CAAM 0009-2022 Data management specification for real-world acupuncture and moxibustion clinical research
T/CGCPU 001-2023 Specification for capacity evaluation of clinical trial coordinator
T/GDPHA 011-2021 Data Element Standard for Clinical Scientific Research of Anxiety Disorder
T/GDPHA 006-2021 Data Element Standard for Clinical Scientific Research of Autism
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/GDPHA 028-2021 Standard Data Set of Clinical Research on Malignant Tumor Diseases
T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
T/GDPHA 029-2021 Standard Data Set of Clinical Research on Diabetes
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CAAM 0012-2020 Data acquisition specification in clinical trials of acupuncture and moxibustion in the real world
T/CGDF 00042-2024 Standard for allergic diseases clinical research base construction
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/CACM 1323-2019 Standard operating procedure for Chinese medicine data monitoring committee of clinical studies
T/CGCPU 017-2021 Quality control requirements for clinical research of CAR-T cell products
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
T/GDPHA 016-2021 Data Element Standard for Clinical Scientific Research of Gastric Cancer
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CACM 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
T/GDPHA 008-2021 Data Element Standard for Clinical Scientific Research of Depression
T/ZJPA 002-2024 Clinical Research Coordinator (CRC) Training Requirement
T/CACM 015.9-2017 Technical specification for the management of clinical research results of traditional Chinese medicine
T/GDPHA 015-2021 Data Element Standard for Clinical Scientific Research of Live Cancer
T/GDPHA 003-2021 Data Element Standard for Clinical Scientific Research of Coronary Heart Disease
T/CAAM 0002-2022 Acupuncture and moxibustion clinical research adverse event recording specification
T/CAAM 0005-2022 General rules for the compilation of real-world acupuncture and moxibustion clinical research norms
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CGCPU 001-2015 Guidance for clinical research coordinator profession practice
T/CRHA 067-2024 The guidelines of clinical research telephone-based follow-up
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/GDPHA 004-2021 Data Element Standard for Clinical Scientific Research of Cerebral Infarction

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

WFAS 009.1-2023 Acupuncture clinical research management standards

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

Beijing Provincial Standard of the People's Republic of China

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

British Standards Institution (BSI)

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
BS ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports
BS ISO 29943-2:2017 Condoms. Guidance on clinical studies. Female condoms, clinical function studies based on self-reports
BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
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 EN 540:1993 Clinical investigation of medical devices for human subjects
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
18/30344902 DC BS EN ISO 14155. 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 14155-2:2003 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 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

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

VN-TCVN

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

Standard Association of Australia （SAA）

AS ISO 14155:2002 Clinical investigation of medical devices

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)

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 14155:2024 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 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 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

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

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

Spanish Association for Standardization (UNE)

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

The Directorate General of Specifications and Metrology (DGSM)

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

US-FCR

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

Danish Standards Foundation

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

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 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
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

SCC

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)

US-HHS

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

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 13503-7:2002 Ophthalmic implants - Intraocular lenses - Clinical investigations

Association Francaise de Normalisation

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

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

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

NL-NEN

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

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

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

PT-IPQ

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

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)

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

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)

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
CGSB 191.1-2013-CAN/CGSB-2013 Oversight of research ethics involving biomedical clinical trials

American Society for Testing and Materials (ASTM)

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

PL-PKN

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

American Petroleum Institute (API)

API PUBL 32-32502-1982 A UNIFIED APPROACH TO THE USE OF HUMAN CLINICAL DATA: CASE STUDY OF NITROGEN DIOXIDE AND SULFUR DIOXIDE

American National Standards Institute （ANSI)

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

IX-EU/EC

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