Glossary

term description adam analysis dataset model (adam) is a cdisc standard that specifies principles for analysis datasets and standards for a subject level analysis file and for a basic data structure asset assets are used to store your metadata content, for example, assets in a standard may include datasets, variables, terminologies and terms you can create assets, edit asset properties, clone assets, view relationships between assets, and so on asset group assets are organized into asset groups a standard or study can contain multiple asset groups, each of which defines a distinct group of content cdisc clinical data interchange standards consortium (cdisc) an organization that develops global standards for medical research it supports the acquisition, exchange, submission and archive of clinical research data and metadata code list a finite list of codes and their meanings that represent the only allowed values for an object container in ryze a container refers to a standard or study credits credit packs allow you to easily purchase software, training and services from formedix crfs case report forms data aquisition data aquisition assets relate to data capture for example, forms, sections and questions dataset a collection of structured data in a single file define xml a standard developed by the cdisc xml technologies team for the transmission of metadata for sdtm, send and adam datasets domain a collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation note the logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial example domains include laboratory test results (lb), adverse events (ae), concomitant medications (cm) edc electronic data capture metadata metadata is data that describes other data this includes a description of the content, context, structure, or purpose of data nci national cancer institute (nci) cdisc partnered with the nci to bring consistency to terminology odm the operational data model (odm) is designed to facilitate the regulatory compliant acquisition archive and interchange of metadata and data for clinical research studies odm is a vendor neutral platform independent format for interchange and archive of clinical study data protocol identifier an alphanumeric name that identifies the document used to define and manage the trial rave rave is an electronic data capture (edc) system produced by medidata rdf resource description framework sas transport files sas transport files store clinical trial data also known as xpt files sdtm study tabulation model (sdtm) is a cdisc standard to guide the organization, structure and format of standard nonclinical tabulation datasets for interchange between organizations send standard for exchange of nonclinical data (send) is a cdisc standard to guide the organization, structure and format of standard non clinical tabluation datasets for exchange between organizations and for submission to the us food and drug administration (fda) value list a domain may require further information describing the possible values for a particular variable variables a set of attributes that makes up a domain ehcr electronic health care records