clinical research

clinical research, Total:69 items.

The international standard classification for "clinical research" includes: Research and development , Birth control. Mechanical contraceptives .

The Chinese standard classification for "clinical research" includes: Standardization and quality management , Other special devices .

Group Standards of the People's Republic of China

T/CGCPU 001-2023 Specification for capacity evaluation of clinical trial coordinator
T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
T/CRHA 067-2024 The guidelines of clinical research telephone-based follow-up
T/CGCPU 001-2015 Guidance for clinical research coordinator profession practice
T/CGDF 00042-2024 Standard for allergic diseases clinical research base construction
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/CMBA 022-2024 Construction and management specification for developing clinical research unit
T/CACM 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
T/CACM 015.2-2017 Formulation of Standard Operating Procedures for Ethical Review of Traditional Chinese Medicine Clinical Research
T/CACM 015.7-2017 Technical specifications for statistical analysis of 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/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CAAM 0002-2022 Acupuncture and moxibustion clinical research adverse event recording specification
T/CACM 1323-2019 Standard operating procedure for Chinese medicine data monitoring committee of clinical studies
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
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 029-2021 Standard Data Set of Clinical Research on Diabetes
T/CHAS 10-2-26-2020 Quality and safety management of Chinese hospital—— Part 2-26：Patient service—Clinical research
T/ZJPA 001-2024 Requirements for Clinical Research Coordinator (CRC) professional ability
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CACM 015.4-2017 Formulation of standard operating procedures for electronic data collection and management of clinical research on traditional Chinese medicine

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 2226-2024 Clinical research data collection and application specifications
DB11/T 2275.3-2024 Malignant Tumor Clinical Research Dataset Part 3: Lung Cancer
DB11/T 2026-2022 Specialized Clinical Research Data Element Mental Disorders

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

SCC

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
NS-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
BS EN 540:1993 Clinical investigation of medical devices for human subjects
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
NS-EN 540:1993 Clinical investigation of medical devices for human subjects
AAMI/ISO 14155:2020 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
ISO 14155:2020 Plus Redline 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

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

Standard Association of Australia （SAA）

AS ISO 14155:2002 Clinical investigation of medical devices

VN-TCVN

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

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

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 14155-2:2009 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

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 14155-2:2009 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)

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

US-HHS

HHS 21 CFR PART 54 CFR PART 54-2011 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

UNKNOWN

WFAS 009.1-2023 Acupuncture clinical research management standards

British Standards Institution (BSI)

BS EN 540:1993(1998) Clinicalinvestigationof 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
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

Association Francaise de Normalisation

NF S99-201:1993 Clinical investigation of medical devices for human subjects.

NL-NEN

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

Danish Standards Foundation

DS/EN 540:1993 Clinical investigation of medical devices for human subjects

GSO

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

KR-KS

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice

RU-GOST R

GOST R 52999.3-2009 Cardiac valve prostheses. Part 3. Guidance on clinical investigation

American National Standards Institute （ANSI)

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