Health Level Seven or HL7 is a range of global standards for the transfer of clinical and administrative health data between applications. The HL7 standards focus on the application layer, which is "layer 7" in the Open Systems Interconnection model. The standards are produced by Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardization. There are a range of primary standards that are commonly used across the industry, as well as secondary standards which are less frequently adopted.
The common warehouse metamodel (CWM) defines a specification for modeling metadata for relational, non-relational, multi-dimensional, and most other objects found in a data warehousing environment. The specification is released and owned by the Object Management Group, which also claims a trademark in the use of "CWM".
Learning Object Metadata is a data model, usually encoded in XML, used to describe a learning object and similar digital resources used to support learning. The purpose of learning object metadata is to support the reusability of learning objects, to aid discoverability, and to facilitate their interoperability, usually in the context of online learning management systems (LMS).
A metadata registry is a central location in an organization where metadata definitions are stored and maintained in a controlled method.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
SDTM 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.
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development. Raw data of toxicology animal studies started after December 18, 2016 to support submission of new drugs to the US Food and Drug Administration will be submitted to the agency using SEND.
Energistics is a global, non-profit, industry consortium that facilitates an inclusive user community for the development, adoption and maintenance of collaborative, open standards for the energy industry in general and specifically for oil and gas exploration and production.
REDCap is a browser-based, metadata-driven EDC software and workflow methodology for designing clinical and translational research databases. It is widely used in the academic research community: the REDCap Consortium is a collaborative, international network of more than 5900 institutional partners in 145 countries, with more than 2.1 million total end-users employing the software. Over 19,000 journal articles cite REDCap.
Additive manufacturing file format (AMF) is an open standard for describing objects for additive manufacturing processes such as 3D printing. The official ISO/ASTM 52915:2016 standard is an XML-based format designed to allow any computer-aided design software to describe the shape and composition of any 3D object to be fabricated on any 3D printer via a computer-aided manufacturing software. Unlike its predecessor STL format, AMF has native support for color, materials, lattices, and constellations.
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
In computing, a data definition specification (DDS) is a guideline to ensure comprehensive and consistent data definition. It represents the attributes required to quantify data definition. A comprehensive data definition specification encompasses enterprise data, the hierarchy of data management, prescribed guidance enforcement and criteria to determine compliance.
An electronic trial master file (eTMF) is a trial master file in electronic format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
3D Manufacturing Format or 3MF is an open source file format standard developed and published by the 3MF Consortium.
The portal for medical data models is a German and European medical research infrastructure. It is an open-access metadata-repository initiated for scientific purposes that can generate, analyse, release and reuse medical forms.
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".
