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Analyzing Clinical Trials

Analyzing Clinical Trials, Total:65 items.

In the international standard classification, Analyzing Clinical Trials involves: Medical sciences and health care facilities in general, Aircraft and space vehicles in general, Medical equipment, First aid, Quality, Pharmaceutics, Test conditions and procedures in general, Laboratory medicine, Dentistry, Inorganic chemicals, Products of the chemical industry, Applications of information technology, Birth control. Mechanical contraceptives.


RU-GOST R, Analyzing Clinical Trials

  • GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 57525-2017 Clinical and economic analysis. General requirements
  • GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
  • GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories
  • GOST R 52379-2005 Good clinical practice (GCP)
  • GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
  • GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
  • GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
  • GOST R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical

Professional Standard - Hygiene , Analyzing Clinical Trials

  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
  • WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology
  • WS/T 403-2012 Analytical quality specifications for routine analytes in clinical biochemistry
  • WS/T 409-2013 Estimation of total analytical error for clinical laboratory methods
  • WS/T 102-1998 Classification and codes of clinical laboratory tests item

Military Standards (MIL-STD), Analyzing Clinical Trials

Group Standards of the People's Republic of China, Analyzing Clinical Trials

  • T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
  • T/NBPIA 007-2021 Classification of hemodialyzer clinical performance
  • T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
  • T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
  • T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
  • T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
  • T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
  • T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
  • T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
  • T/CGCPU 012-2020 File management standards for clinical trial institutions
  • T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
  • T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
  • T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
  • T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
  • T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
  • T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
  • T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
  • T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
  • T/CGCPU 023-2023 Evaluation standard for clinical trial management system document

American Society for Testing and Materials (ASTM), Analyzing Clinical Trials

  • ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery

Zhejiang Provincial Standard of the People's Republic of China, Analyzing Clinical Trials

  • DB33/T 903-2013 Classification and coding of clinical laboratory test items

Professional Standard - Medicine, Analyzing Clinical Trials

CZ-CSN, Analyzing Clinical Trials

US-AAMI, Analyzing Clinical Trials

Danish Standards Foundation, Analyzing Clinical Trials

  • DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

IT-UNI, Analyzing Clinical Trials

Association Francaise de Normalisation, Analyzing Clinical Trials

  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • NF EN ISO 18812:2003 Informatique de santé - Interfaces d'analyseur clinique pour systèmes d'information de laboratoire - Profils d'utilisation

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Analyzing Clinical Trials

卫生健康委员会, Analyzing Clinical Trials

British Standards Institution (BSI), Analyzing Clinical Trials

  • DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

国家卫生计生委, Analyzing Clinical Trials

  • WS/T 494-2017 Analysis quality requirements for important routine items in clinical qualitative immunoassay testing

European Committee for Standardization (CEN), Analyzing Clinical Trials

  • 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)

AT-ON, Analyzing Clinical Trials

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

Lithuanian Standards Office , Analyzing Clinical Trials

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

PL-PKN, Analyzing Clinical Trials

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

German Institute for Standardization, Analyzing Clinical Trials

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

AENOR, Analyzing Clinical Trials

  • UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

Korean Agency for Technology and Standards (KATS), Analyzing Clinical Trials

  • KS P 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
  • KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects-Part 2:Clinical investigation plans
  • KS X ISO 18812-2016(2021) Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles

CU-NC, Analyzing Clinical Trials

  • NC 20-25-6-1988 Medical Sciences. Clinical Auxiliary Methods and Means Photometric Determination of Creatinine. Method of Clinical Analyses

International Organization for Standardization (ISO), Analyzing Clinical Trials

  • ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants

ZA-SANS, Analyzing Clinical Trials

  • SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties




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