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ISO 14155
ISO 14155 ''Clinical investigation of medical devices for human subjects -- Good clinical practice'' This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices. This standard was developed by ISO technical committee ISO/TC 194. ISO 14155 was published in its second edition in February 2011. The third edition was released in July 2020. Edition and revision The first edition of ISO 14155-1 was published on 15 February 2003. The second revision of the standard was released in February 2011, the third revision and therefore current version of the standard was released in July 2020, ISO 14155:2020. Main requirements of the standard The ISO 14155 adopts the structure in the following breakdown: # Scope # Normative references # Ter ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Organization For Standardization
The International Organization for Standardization (ISO ) is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and (as of November 2022) it has published over 24,500 international standards covering almost all aspects of technology and manufacturing. It has 809 Technical committees and sub committees to take care of standards development. The organization develops and publishes standardization in all technical and nontechnical fields other than electrical and electronic engineering, which is handled by the IEC.Editors of Encyclopedia Britannica. 3 June 2021.International Organization for Standardization" ''Encyclopedia Britannica''. Retrieved 2022-04-26. It is headquartered in Geneva, Switzerland, and works in 167 countries . The three official languages of the ISO are English, Fren ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of International Organization For Standardization Standards
This is a list of publishedThis list generally excludes draft versions. International Organization for Standardization (ISO) standards and other deliverables.ISO deliverables include "specifications" (ISO/PAS, ISO/TS), "reports" (ISO/TR), etc, which are not referred to by ISO as "standards". For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. The standards are protected by and most of them must be purchased. However, about 300 of the standards produced by ISO and 's Joint Technical Committee 1 ( |
Nuremberg Code
The Nuremberg Code (german: Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in '' U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the Second World War. Though it was articulated as part of the court's verdict in the trial, the Code would later become significant beyond its original context; in a review written on the 50th anniversary of the ''Brandt'' verdict, Jay Katz writes that "a careful reading of the judgment suggests that he authorswrote the Code for the practice of human experimentation whenever it is being conducted." Background The origin of the Code began in pre–World War II German politics, particularly during the 1930s and 1940s. Starting in the mid-1920s, German physicians, usually proponents of racial hygiene, were accused by the public and the medical society of unethical medical practices. The use of racial hygiene was supported by the German government in order to promote ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standards For Electronic Health Records
Standard may refer to: Symbols * Colours, standards and guidons, kinds of military signs * Standard (emblem), a type of a large symbol or emblem used for identification Norms, conventions or requirements * Standard (metrology), an object that bears a defined relationship to a unit of measure used for calibration of measuring devices * Standard (timber unit), an obsolete measure of timber used in trade * Breed standard (also called bench standard), in animal fancy and animal husbandry * BioCompute Standard, a standard for next generation sequencing * ''De facto'' standard, product or system with market dominance * Gold standard, a monetary system based on gold; also used metaphorically for the best of several options, against which the others are measured * Internet Standard, a specification ratified as an open standard by the Internet Engineering Task Force * Learning standards, standards applied to education content * Standard displacement, a naval term describing the weig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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