Clinical Evaluation Data

Clinical Evaluation Data, Total:42 items.

The international standard classification for "Clinical Evaluation Data" includes: .

The Chinese standard classification for "Clinical Evaluation Data" includes: .

Beijing Provincial Standard of the People's Republic of China

DB11/T 2026-2022 Specialized Clinical Research Data Element Mental Disorders

Fujian Provincial Standard of the People's Republic of China

DB35/T 1985-2021 Primary Liver Cancer Clinical Dataset
DB35/T 1330-2013 Basic data set of clinical nursing quality assessment project

Group Standards of the People's Republic of China

T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CRHA 066-2024 Meta data model and data quality evaluation specification for clinical research of lymphoma
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CMEAS 020-2024 Specifications for the Construction and Evaluation of Pediatric Clinical Data Elements
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CIATCM 030.1-2019 Basic datasets for clinical nursing in the hospitals of Traditional Chinese Medicine—Part1: Nursing Valuation Records
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 001-2023 Specification for capacity evaluation of clinical trial coordinator
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CAAM 0006-2022 Data quality assessment specification for real-world acupuncture and moxibustion clinical research
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CHIA 54.3-2025 Basic Data Set Standard for Clinical Research on Cervical Spondylosis Part 3: Evaluation Records
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials

European Union/Commission

MEDDEV 2.7.1-2003 EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIFIED BODIES
MEDDEV 2.7.1 APP 1-2008 GUIDELINES ON MEDICAL DEVICES EVALUATION OF CLINICAL DATA - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES - Appendix 1 : Clinical Evaluation of Coronary Stents (Rev 3)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

Gosstandart of Russia

GOST R 56429-2015 Medical devices. Clinical evaluation
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation

British Standards Institution (BSI)

PD ISO/TR 24290:2023 Health informatics. Datasets and data structure for clinical and biological evaluation metrics in radiotherapy
BS PD ISO/TR 24290:2023 Health informatics. Datasets and data structure for clinical and biological evaluation metrics in radiotherapy
24/30506234 DC BS EN ISO 12487 Medical electrical equipment — Clinical performance evaluation of clinical thermometers

Danish Standards Foundation

DANSK DS/ISO/TR 24290:2023 Health informatics – Datasets and data structure for clinical and biological evaluation metrics in radiotherapy

International Organization for Standardization (ISO)

ISO/TR 24290:2023 Health informatics — Datasets and data structure for clinical and biological evaluation metrics in radiotherapy
ISO/DTR 24290 Health informatics — Datasets and data structure for clinical and biological evaluation metrics in radiotherapy

American Dental Association

ADA 1000-2010(R2020) Standard Clinical Data Architecture
ADA 1039-2006(R2014) Standard Clinical Conceptual Data Model

American National Standards Institute （ANSI)

ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/ADA 1000-2010 Standard Clincal Data Architecture
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model
ANSI/ADA 103-1999(2010) Standard Clinical Conceptual Data Model

Association for the Advancement of Medical Instrumentation

AAMI TIR9:1992(R2019) Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring

European Committee for Standardization (CEN)

prEN ISO 12487 Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)

German Institute for Standardization

DIN EN ISO 12487 E:2025-01 Draft Document - Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024