Blind design of drug clinical studies

Blind design of drug clinical studies, Total:66 items.

The international standard classification for "Blind design of drug clinical studies" includes: Research and development .

The Chinese standard classification for "Blind design of drug clinical studies" includes: Standardization and quality management .

Group Standards of the People's Republic of China

T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CGCPU 002-2016 The standard of on-site inspection for clinical investigational drug centralized management
T/CACM 015.9-2017 Technical specification for the management of clinical research results 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 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
T/CMBA 022-2024 Construction and management specification for developing clinical research unit
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CACM 1323-2019 Standard operating procedure for Chinese medicine data monitoring committee of clinical studies
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine

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

National Health Commission of the People's Republic of China

Pharma-Guidelines-Nanodrug003 Technical Guiding Principles for Non-clinical Safety Research of Nanomedicines (Trial Implementation)
Pharma-Guidelines-Nanodrug002 Technical Guiding Principles for Nonclinical Pharmacokinetic Research of Nanomedicines (Trial Implementation)

未注明发布机构

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)

Shanghai Provincial Standard of the People's Republic of China

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

Hunan Provincial Standard of the People's Republic of China

DB43/T 2896-2023 Standards for the construction and operation management of practical training bases for principal investigators in drug clinical trials

SCC

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

RU-GOST R

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
GOST R 56702-2015 Medicines for medical applications. Nonclinical toxicology and pharmacokinetic studies of safety

PT-IPQ

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

European Committee for Standardization (CEN)

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
prEN 540-1992 Clinical investigation of medical devices for human subjects
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

VN-TCVN

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

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

KR-KS

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

British Standards Institution (BSI)

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 ISO 14155-2:2003 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 ISO 14155:2011 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 81060-3:2022 Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type
BS ISO 81060-2:2013 Non-invasive sphygmomanometers. Clinical investigation of automated measurement type

US-HHS

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

ES-UNE

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

Association Francaise de Normalisation

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

International Organization for Standardization (ISO)

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice

German Institute for Standardization

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

NL-NEN

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

GOST

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice

Others: