This Therapeutic Area Data Standards User Guide for _Therapeutic_Area_ (TAUG-_TA_) was developed under the Coalition for Accelerating Standards and Therapies (CFAST) initiative.
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Teams: you must customize this page at least a little. Do something to bring some personality to the document! It needs to be a little different for each TA guide, to encourage those who read more than one to not get into the habit of skipping sections. For instance, if the document was not developed under the CFAST initiative, then of course you will want to change the first sentence above so that it's no longer telling lies. Use that first change as a springboard – and don't be afraid to wander from a fully formal style of writing. The more it feels like boilerplate, the easier it is to skim. If you have difficulty thinking of how to customize this page, try talking to your clinical experts, other project managers, and the program-level staff. It will probably be a collaborative effort. |
The purpose of this TAUG-___ The Cardiac Imaging Supplement to the TAUG-Duchenne Muscular Dystrophy v1.0 was developed under the CDISC standards development process. 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_ studies. This _nth_ version (v#) focuses on ____________________________________________________.
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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 over-interpreted. 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.
In place of the underscore above, insert a broad description of the scope of the project. Here are some examples to start you off:
- "clinical trials of drugs to treat asthma in an adult population"
- "phase 1-3 clinical trials of drugs to treat the chronic infection of hepatitis C genotypes 1-6 in adults in the outpatient setting"
- "traumatic brain injury in adults"
(This does not count as part of customizing the introduction.)
If you want to expand on what is currently out of scope but might be in scope in later versions, feel free. If you want to link to the project proposal in the appendices, again, feel free.
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