submission model

submission model

A set of data standards—e.g., SDTM, ADaM and define.xml—for representing data related to a clinical trial, which are submitted to regulatory authorities to support product marketing applications.

CDISC submission data
Tabulations of essential patient; analysis data structured to support analysis and interpretation; metadata descriptions.
References in periodicals archive ?
Sparta Systems has been in close communication with the FDA as the proposed legislation has been refined, and proactively provides its customers with an enterprise-wide quality management system that allows for a seamless transition from the current paper-based system to an electronic submission model.
An open submission model will allow for seamless wide scale adoption by the recording industry for electronic lending documents.
In a recent letter from the FDA to the CDISC SDS team, Janet Woodcock, director, Center for Drug Evaluation and Research, and Randy Levin, associate director for Information Management for the Center, write, "Congratulations on the publication of the Clinical Trial Data Regulatory Submission Model at HL7
The CTSIG and CDISC representatives will work to harmonize the existing CDISC information models with the HL7 Reference Information Model (RIM), evaluate the CDISC submission model and Operational Data Model DTD, conduct DTD cross reference analysis, and determine the applicability of HL7's Clinical Document Architecture (CDA) standard to future CDISC initiatives.
After years of working with the old paper submission model, the members that make up the management team at iwix.