Toward a Comprehensive CDISC Submission Data Standard

Abstract

This article proposes a comprehensive set of data standards to address the submission of clinical data based on the work of the Clinical Data Interchange Standards Consortium (CDlSC). The present components of the CDISC submission standards are described and related to Food and Drug Administration guidelines on submission as expressed in the 1999 guidance documents on regulatory submissions and the 2005 guidance on the electronic Common Technical Document (eCTD). The relative rdes of the CDlSC Study Data Tabulation Model (SDTM); the Case Report Tabulation Data Description Specification (define.xml), which is based on the CDlSC Operational Data Model (ODM); and the Analysis Dataset Models (ADaM) in meeting submission data requirements are next described. Finally, this article discusses implementation alternatives for sponsors, fiture directions, and the potential benefit of current projects to improve the submission process.

Current applications and future directions for the CDISC Operational Data Model standard: A methodological review

“…The Define-XML standard is an ODM extension that provides metadata to describe tabular datasets that, when used within the context of the CDISC content standards, typically describes all the SDTM, ADaM, or SEND datasets for a study [9, 89–93]. Define-XML plays a key role in establishing traceability in regulatory submission datasets [94].…”

“…Define-XML plays a key role in establishing traceability in regulatory submission datasets [94]. The FDA added Define-XML to its Study Data Specifications in March of 2005 [3, 9], and in December 2016 it will become a requirement for submissions to the FDA [3, 14]. The FDA requirement to use the relatively archaic SAS V5 XPORT format for submission data has necessitated that the metadata be provided in a separate document [9].…”

“…The FDA added Define-XML to its Study Data Specifications in March of 2005 [3, 9], and in December 2016 it will become a requirement for submissions to the FDA [3, 14]. The FDA requirement to use the relatively archaic SAS V5 XPORT format for submission data has necessitated that the metadata be provided in a separate document [9]. To support the submission process, the ability to validate the Define-XML metadata has become increasingly important necessitating the development of validation rules and the tools that apply them, such as OpenCDISC [95] or the CDISC Define.xml Checker [96].…”

“…To support the submission process, the ability to validate the Define-XML metadata has become increasingly important necessitating the development of validation rules and the tools that apply them, such as OpenCDISC [95] or the CDISC Define.xml Checker [96]. Kubick et al [9] also note that the type of rich metadata provided in Define-XML is necessary for supporting integrated clinical research data repositories.…”

“…The original objective when work started in 1999 was to address the data interchange and study archival use cases. Kubick et al [9] described ODM as established to support the essential information needs of electronic data capture (EDC) systems and paper CRF data entry systems. Other key requirements included a 21 CFR Part 11 compliant audit trail, and long-term data archival support [10].…”