ODM4 Submissions

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Project Overview

Project Scope

Deliverable: This project will deliver a paper that proposes the use of ODM-based data exchange standards for regulatory submissions.

Widespread support exists for modernizing the data transport format for the standardized submissions of clinical research data as part of an application to a regulatory authority. Despite the known limitations of the outdated SAS® Version 5 Transport (SAS V5 XPORT) format, it remains the current standard transport format for regulatory submission datasets. Its limitations are impacting the CDISC standards data representations as well as the technologies available to support data exchange. The Operational Data Model (ODM) standard has been the CDISC standard format for data exchange since 2000. Define-XML and Dataset-XML are ODM extensions supporting the transport of CDISC dataset metadata and data, respectively. Define-XML is now a required part of a regulatory submission. However, despite using Define-XML to submit dataset metadata, other data and metadata required for submissions are submitted in different file formats that adversely restrict data representation, machine-readability options, and the ability to validate submissions. This paper describes how the use of the existing ODM standards could simplify and modernize data exchange in support of regulatory submissions, as well as improving data exchange practices in other areas of clinical research.

The ODM standard is mature and widely implemented by many existing technology solutions which reduces implemetation barriers for ODM-based submissions. Furthermore, use of the current ODM version would provide a migration path towards ODM version 2 and a future that takes advantage of modern APIs for data exchange rather than replying on file-based exchange processes. In addition to providing a standardized API, ODMv2 includes support for other modern transport formats such as JSON, improves alignment with FHIR for EHR integration, extends access to additional machine readable metadata such as study designs, and improves the ability to semantically annotate content.

Project Leads

Name Role Organization E-mail
Sam Hume Co-Lead and Project Manager CDISC shume@cdisc.org
Marcelina Hungria Co-Lead CDISC/DIcore/PhUSE mhungria@dicoregroup.com
Nate Blevins Co-Lead GSK nate.c.blevins@gsk.com

Project Members

Name Organisation

Project Updates

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Date: Description of Update

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Recruit project team 10-Jan-2017 - 22-Dec-2017
Initial draft paper outline 01-Nov-2017 - 22-Dec-2017
Interviews 08-Jan-2018 - 03-Feb-2018
Analysis of interview results 16-Feb-2018 - 30-Mar-2018
Draft paper 15-Mar-2018 - 30-Apr-2018
Internal review including WG leads 01-May-2018 - 15-June-2018
Review with SC 05-May-2018 - 15-Jun-2018
Public review with comment resolution 16-Jun-2018 - 21-Aug-2018

Project Activities

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Meeting Minutes