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Clinical Trials
Clinical Trials, Total:69 items.
In the international standard classification, Clinical Trials involves: Medical sciences and health care facilities in general, Pharmaceutics, Test conditions and procedures in general, Dentistry, Quality, Birth control. Mechanical contraceptives, Medical equipment, Laboratory medicine, Terminology (principles and coordination), Applications of information technology.
Group Standards of the People's Republic of China, Clinical Trials
- T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
- 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/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
- T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
- T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
- T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
- T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
- T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
- T/CGCPU 016-2021 Technical requirements for clinical trials of new drugs for oral inhalation of respiratory system in pediatric populations
- T/CACM 1351-2021 Standards for collection, preservation and transportation of fecal microbial samples in clinical trials of TCM
- T/CACM 1333.1-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 1: Anorexia
- T/CACM 1333.4-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric series of common diseases Part 4: Diarrhea in children
- T/CACM 1333.3-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric common diseases Part 3: Functional abdominal pain
- T/CACM 1333.2-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 2: functional constipation
RU-GOST R, Clinical Trials
- GOST R 52379-2005 Good clinical practice (GCP)
- GOST ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
- 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 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
- GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
Professional Standard - Medicine, 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
Canadian General Standards Board （CGSB), Clinical Trials
ZA-SANS, Clinical Trials
- SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties
US-AAMI, Clinical Trials
Danish Standards Foundation, Clinical Trials
- DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
- DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
IT-UNI, Clinical Trials
Association Francaise de Normalisation, Clinical Trials
- NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
- NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
- NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques
- NF S94-801:2007 Vaginal reinforcement implant for stress urinary incontinence and/or pelvic organ prolapse repair surgery through vaginal approach - Pre-clinical and clinical tests.
American Society for Testing and Materials (ASTM), 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 F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
Korean Agency for Technology and Standards (KATS), Clinical Trials
International Organization for Standardization (ISO), Clinical Trials
- ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
- ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1
AT-ON, Clinical Trials
- OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Lithuanian Standards Office , Clinical Trials
- LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
PL-PKN, 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, Clinical Trials
- DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
AENOR, Clinical Trials
- UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Professional Standard - Agriculture, Clinical Trials
- 农业部1596号公告-1-2011 Technical guidelines for clinical trials of traditional Chinese medicines and natural medicines for veterinary use
- 农业部1596号公告-2-2011 Writing principles of clinical trial reports of traditional Chinese medicine and natural medicine for veterinary use
Hunan Provincial Standard of the People's Republic of China, Clinical Trials
- DB43/T 2135-2021 Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects
KR-KS, Clinical Trials
British Standards Institution (BSI), Clinical Trials
- BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
European Committee for Standardization (CEN), 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)
American National Standards Institute （ANSI), Clinical Trials
- ANSI/HL7 V3 PORT, R 1-2004 HL7 Version 3 Standard: Regulated Studies - Periodic Reporting of Clinical Trials Laboratory Results, , Release 1