Cardiovascular and Tuberculosis Data Standards

Package #1 for the Cardiovascular and Tuberculosis therapeutic specific data elements are now posted for public review.

The purpose of these projects is to develop clinical content data standards supporting both patient care and secondary data uses which include disease surveillance, quality improvement and clinical research. This work is funded through the NIH Re-Engineering the Clinical Research Enterprise Roadmap contracts. The resulting data elements and products were developed by a team from Industry; Standards Development Organizations, including CDISC and HL7; and Clinician and Government Stakeholders over the last 2.5 years.

The work focused on two separate clinical domains: Cardiovascular and Tuberculosis. Because these domains are large, they have been further broken down into packages. For the Cardiovascular domain, the Package 1 scope is Acute Coronary Syndrome and for Tuberculosis (TB), the focus is on Pulmonary TB.

The data elements with their definitions and permissible value sets were developed from Patient Use Case Scenarios and Activity Flow diagrams. These data elements were incorporated into class models, using Unified Modeling Language (UML), to illustrate the relationship of the data elements to each other. An example of how the data elements are produced in a form format is also included and the Tuberculosis data elements have been modeled in the SDTM format.

There are supporting documents to provide guidance on how to navigate through the products. There is an Index Document that provides a brief description of each document in the packet, and indicates which documents are for review and which are supporting documents. Hyperlinks are provided to help you navigate through each document.

The Project Document provides an overview of the project and a detailed explanation of the products in the packet. The Understanding Class Model Document gives an overview of the model and how to read it. The TB Implementation in SDTM provides guidance of how TB healthcare data standards could be implemented in clinical research using the CDISC Study Data Tabulation Model (SDTM) to aggregate data across research studies.

There is a comment form for each project to collect feedback and to indicate what materials you reviewed but did not have comments.

Through this work, we hope to provide and facilitate a path for others to follow as clinical content is defined with the semantic specificity necessary for interoperability.

Please review any of the products within the packages that fit your area of expertise.

Please use the comment spreadsheet included with the downloads to submit comments to jevans@cdisc.org by 30 April 2008.

Click here to download the Cardiovascular Standards Package 1.0.

Click here to download the Tuberculosis Standards Package 1.0.