The Cardiac Imaging Supplement to the TAUG-Duchenne Muscular Dystrophy v1.0 was developed using the CDISC standards development process with support from the Cardiac Working Group members on behalf of the Duchenne Regulatory Science Consortium at Critical Path Institute. This process includes collecting input from various stakeholders to ensure the standard is as thorough as possible. A number of volunteers and experts provided resources and input to support the development of this standard. The goal of this initiative is to identify a core set of clinical therapeutic area concepts and endpoints for targeted therapeutic areas and translate them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory submission. As with all CDISC therapeutic area standards, the purpose of this standard is to describe how to use CDISC standards to represent data pertaining to a targeted therapeutic area.
The biomedical concepts covered in this guide were selected from concepts identified by one or more stakeholders as important, and which were not addressed or were not completely addressed by existing CDISC implementation guides. This user guide does not provide guidance on what data are needed for regulatory submission or approval; it only provides advice on how to represent data in a standard form.
To reiterate: It is important to note that the choice of biomedical concepts included in this user guide is not intended to influence sponsor decisions as to what data to collect. The examples included are intended to show how particular kinds of data can be represented using CDISC standards. This user guide emphasizes that examples are only examples and should not be overinterpreted. For guidance on the selection of biomedical concepts and endpoints, please refer to the appropriate clinical and regulatory authorities.
Clinical guidelines, articles, and other works consulted by the team during the creation of this document are referenced where appropriate, using the American Medical Association (AMA) style for citation. For the sources cited in this document and suggestions for further reading, see Appendix D, References.