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JANUS Clinical Trial Data Repository
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future. The analogy is that the Janus data repository would enable the FDA and the pharmaceutical industry to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials (or even future clinical trials thru better enablement of clinical trial design). The Janus data model is a relational database model, and is based on SDTM as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard. For example, Janus can store pre-clinical trial (non-human) submission informat ... [...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] |
Data Warehouse
In computing, a data warehouse (DW or DWH), also known as an enterprise data warehouse (EDW), is a system used for Business reporting, reporting and data analysis and is considered a core component of business intelligence. DWs are central Repository (version control), repositories of integrated data from one or more disparate sources. They store current and historical data in one single place that are used for creating analytical reports for workers throughout the enterprise. The data stored in the warehouse is uploaded from the operational systems (such as marketing or sales). The data may pass through an operational data store and may require data cleansing for additional operations to ensure data quality before it is used in the DW for reporting. Extract, transform, load (ETL) and extract, load, transform (ELT) are the two main approaches used to build a data warehouse system. ETL-based data warehousing The typical extract, transform, load (ETL)-based data warehouse uses ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Roman God
Roman mythology is the body of myths of ancient Rome as represented in the literature and visual arts of the Romans. One of a wide variety of genres of Roman folklore, ''Roman mythology'' may also refer to the modern study of these representations, and to the subject matter as represented in the literature and art of other cultures in any period. Roman mythology draws from the mythology of the Italic peoples and ultimately from Proto-Indo-European mythology. Roman mythology also draws directly on Greek mythology, potentially as early as Rome's protohistory, but primarily during the Hellenistic period of Greek influence and through the Roman conquest of Greece, via the artistic imitation of Greek literary models by Roman authors. The Romans identified their own gods with those of the ancient Greeks—who were closely historically related in some cases, such as Zeus and Jupiter—and reinterpreted myths about Greek deities under the names of their Roman counterparts. Greek and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Janus (mythology)
In ancient Roman religion and myth, Janus ( ; la, Ianvs ) is the god of beginnings, gates, transitions, time, duality, doorways, passages, frames, and endings. He is usually depicted as having two faces. The month of January is named for Janus (''Ianuarius''). According to ancient Roman farmers' almanacs, Juno was mistaken as the tutelary deity of the month of January; but, Juno is the tutelary deity of the month of June. Janus presided over the beginning and ending of conflict, and hence war and peace. The gates of a building in Rome named after him (not a temple, as it is often called, but an open enclosure with gates at each end) were opened in time of war, and closed to mark the arrival of peace. As a god of transitions, he had functions pertaining to birth and to journeys and exchange, and in his association with Portunus, a similar harbor and gateway god, he was concerned with travelling, trading and shipping. Janus had no flamen or specialised priest ''( sacerdos)'' a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Model
A data model is an abstract model that organizes elements of data and standardizes how they relate to one another and to the properties of real-world entities. For instance, a data model may specify that the data element representing a car be composed of a number of other elements which, in turn, represent the color and size of the car and define its owner. The term data model can refer to two distinct but closely related concepts. Sometimes it refers to an abstract formalization of the objects and relationships found in a particular application domain: for example the customers, products, and orders found in a manufacturing organization. At other times it refers to the set of concepts used in defining such formalizations: for example concepts such as entities, attributes, relations, or tables. So the "data model" of a banking application may be defined using the entity-relationship "data model". This article uses the term in both senses. A data model explicitly determines the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Relational Database
A relational database is a (most commonly digital) database based on the relational model of data, as proposed by E. F. Codd in 1970. A system used to maintain relational databases is a relational database management system (RDBMS). Many relational database systems are equipped with the option of using the SQL (Structured Query Language) for querying and maintaining the database. History The term "relational database" was first defined by E. F. Codd at IBM in 1970. Codd introduced the term in his research paper "A Relational Model of Data for Large Shared Data Banks". In this paper and later papers, he defined what he meant by "relational". One well-known definition of what constitutes a relational database system is composed of Codd's 12 rules. However, no commercial implementations of the relational model conform to all of Codd's rules, so the term has gradually come to describe a broader class of database systems, which at a minimum: # Present the data to the user as relati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
SDTM
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management. Background SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Common Data Model
A common data model (CDM) can refer to any standardised data model which allows for data and information exchange between different applications and data sources. Common data models aim to standardise logical infrastructure so that related applications can "operate on and share the same data", and can be seen as a way to "organize data from many sources that are in different formats into a standard structure". A common data model has been described as one of the components of a " strong information system". A standardised common data model has also been described as a typical component of a well designed agile application besides a common communication protocol. Providing a single common data model within an organisation is one of the typical tasks of a data warehouse. Examples of common data models Border crossings X-trans.eu was a cross-border pilot project between the Free State of Bavaria (Germany) and Upper Austria with the aim of developing a faster procedure for the ap ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Databases In The United States
In computing, a database is an organized collection of data stored and accessed electronically. Small databases can be stored on a file system, while large databases are hosted on computer clusters or cloud storage. The design of databases spans formal techniques and practical considerations, including data modeling, efficient data representation and storage, query languages, security and privacy of sensitive data, and distributed computing issues, including supporting concurrent access and fault tolerance. A database management system (DBMS) is the software that interacts with end users, applications, and the database itself to capture and analyze the data. The DBMS software additionally encompasses the core facilities provided to administer the database. The sum total of the database, the DBMS and the associated applications can be referred to as a database system. Often the term "database" is also used loosely to refer to any of the DBMS, the database system or an application ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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