Maximizing CDISC standards for specification of submission deliverable documents

Abstract

CDSIC standards were originally developed for documentation purposes in the form of metadata standards describing submission deliverables. Many tools, vendors, and sponsor efforts have gone into verifying that submission documents adhere to those standards. By turning the beast on its head, the very same metadata can be used to create those submission deliverables from the specifications using validated computer code, thus eliminating the bulk of controls and verification for a study.The core principle is that the task of ensuring that two documents are identical (or similar) by comparing and checking, can be eliminated by creating one from the other in a systematic and automatic way by computer code.ODM-XML is the primary specification document for eCRF derivates from CDISC, a pure XML metadata specification documenting the collection of clinical data, not the actual collected clinical data itself. The corresponding submission deliverables are the blank CRF (bcrf.pdf) and the SDTM annotated CRF (acrf.pdf). A CDISC compliant EDC systems ought to be able to use the ODM-XML itself more or less directly to set the eCRF by a simple upload of the ODM-XML into the systems.Bridging the gap from ODM-XML to submission deliverables is quite simply done by  applying a style sheet (a special translating style sheet) to the ODM-XML file to display it as either an eCRF specification, one of the submission documents, or as another XML file for uploading into a specific EDC system. Whenever the desired document is of the same file format, the same stylesheet can be applied varying only in a specified parameter, guaranteeing the similarity of those documents as they originate from the same source.Define-xml is a well-established standard for documenting submission data. The standard way of displaying define-xml is through a similar style sheet provided by CDISC, containing links into targets in the SDTM annotated CRF (acrf.pdf) document.This article demonstrates how the submission documents can be created through careful definition of the ODM-XML, and applying a style sheet creating targets in the SDTM annotated CRF (acrf.pdf) for enhanced linking between this document and the define-xml document. Furthermore, this technique will demonstrate creation of an SDTM annotated specification for setting up an eCRF, as well as creation of the blank CRF (bcrf.pdf) document, all from a single source of metadata.