This Therapeutic Area Data Standards User Guide for _Therapeutic_Area_ (TAUG-_TA_) was developed under the Coalition for Accelerating Standards and Therapies (CFAST) initiative.
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-___ is to describe how to use CDISC standards to represent data pertaining to _therapeutic_area_ studies. This _nth_ version (v#) focuses on ____________________________________________________.
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.
(This may count as part of customizing the introduction, depending on how common it becomes.)