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Analyzing Clinical Trials

Analyzing Clinical Trials, Total:113 items.

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


RU-GOST R, Analyzing Clinical Trials

  • 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 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 57525-2017 Clinical and economic analysis. General requirements
  • 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 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
  • 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 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
  • 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 ISO 14155-2014 Clinical investigation. Good clinical practice
  • 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, Analyzing Clinical Trials

  • GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
  • GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
  • GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals

Professional Standard - Hygiene , Analyzing Clinical Trials

  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
  • WS/T 406-2024 Quality Standards for Analysis of Common Items in Clinical Blood Tests
  • WS/T 403-2024 Analytical quality standards for common items in clinical chemistry tests
  • 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 834-2024 Clinical application of Toxoplasma gondii test
  • 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
  • WS/T 409-2024 Evaluation of the total analytical error of clinical quantitative detection methods
  • WS/T 251-2005 Guidelines for Clinical Laboratory Safety

Military Standards (MIL-STD), Analyzing Clinical Trials

GSO, Analyzing Clinical Trials

  • BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device

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/SSFSIDC 015-2023 Clinical trial data collection requirements
  • T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
  • T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
  • T/CGCPU 012-2020 File management standards for clinical trial institutions
  • 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 024-2022 Specification for training management of practitioners in clinical trial institution
  • T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
  • T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
  • T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
  • T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
  • T/NBPIA 010-2023 Clinical Practice Guidelines for Home Hemodialysis
  • 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/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
  • T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
  • T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
  • T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
  • T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
  • T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
  • T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
  • T/SHQAP 016-2024 Drug clinical trial management system — Dataset specification
  • T/JPMA 023-2024 Specification for safety follow-up of vaccine clinical trials
  • T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
  • T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
  • T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
  • T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
  • T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product

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
  • ASTM E2045-99 Standard Practice for Detailed Clinical Observations of Test Animals

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

  • YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
  • YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
  • YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials

Association Francaise de Normalisation, Analyzing Clinical Trials

CZ-CSN, Analyzing Clinical Trials

US-AAMI, Analyzing Clinical Trials

IT-UNI, 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

衛(wèi)生健康委員會(huì), Analyzing Clinical Trials

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

國(guó)家衛(wèi)生計(jì)生委, Analyzing Clinical Trials

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

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
  • BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans

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)
  • EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003

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)

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)

AT-ON, Analyzing Clinical Trials

  • OENORM EN ISO 14155:2021 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)

Spanish Association for Standardization (UNE), 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 8430-2020 Management and safety requirements for clinical laboratory pre-analytical automation system
  • 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
  • KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects-Part 2:Clinical investigation plans

SCC, Analyzing Clinical Trials

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

司法部, Analyzing Clinical Trials

Professional Standard - Certification and Accreditation, Analyzing Clinical Trials

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

South African Bureau of Standard, Analyzing Clinical Trials

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

Professional Standard - Public Safety Standards, Analyzing Clinical Trials

中華人民共和國(guó)國(guó)家衛(wèi)生和計(jì)劃生育委員會(huì), Analyzing Clinical Trials

Canadian General Standards Board (CGSB), Analyzing Clinical Trials

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Analyzing Clinical Trials

Professional Standard - Commodity Inspection, Analyzing Clinical Trials

  • SN/T 4401.1-2015 Methods of qualitative and quantitative analysis for drug in clinical sample.Part 1:Ketamine

Professional Standard - Agriculture, Analyzing Clinical Trials

KR-KS, Analyzing Clinical Trials

  • KS X ISO 18812-2016 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles




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