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.

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.)

Completing this section

• Fill in the blanks in step 1 with (a) the names of the foundational standards upon which this document is based, and (b) what, in general, the reader should already be familiar with before reading this guide (such as the CDISC data models and their general rules for implementation).
• Fill in the blank in the paragraph below with the tiny link (such as the one to Introduction to Therapeutic Area Standards above) to the Draft Standards of Interest (DSoI) page for the guide; or if there are no draft standards of interest, remove the paragraph.
• All fill-in-the-blanks must be replaced with actual text before the document can go to internal review.

Expanding on this section

• The instructions above, and both paragraphs below, are all extensible. They can also be modified slightly, so long as their basic meaning is unaltered.
• Any additional instructions should not be simply appended to the end of the steps above, but be inserted so that the entire set of instructions reads in approximate chronological order.
• Any companion documents (or list of such) should be added to the first paragraph below, either before or after the sentence provided depending on whether you think they're more or less important and/or interesting than the DSoIs. More important/interesting companion documents go first.
• Any additional caveats or disclaimers — assuming they do not simply restate a general caveat already given in Introduction to Therapeutic Area Standards — should be added to the second paragraph below, after the sentence provided.
• Additions to the steps above should be written in the imperative; to the paragraphs below in the indicative (see also: Grammatical mood at Wikipedia).

The TAUG Content Guide has some default language for sections, but don't rely too heavily on this if you can avoid it.

Change the name of this page to reflect the name of the team.

Names are given in natural order (e.g. the given name preceding the family name in Western cultures). With the exception of the team lead(s), team members should be listed in order by surname.

This is the preliminary glossary. Add and/or remove entries so that it includes terms used in this standard that readers may wish to look up, and does not include any terms that are not used in the guide.

If no NSVs use a CDISC/NCI codelist, then remove the line in italics under the table.

Not every sub-section of this appendix will necessarily apply to any given TA standard. If the section does not apply, remove it.

The sections are given together on this page in the template, but should be split into individual child pages once it's clear which ones will be kept.

Works Cited

• This list contains the full reference information for works cited within the document. Each item pairs with the inline citation(s) with which it shares its ordinal number.
• By the time of publication, works should be given in the order of first citation within the document, and use AMA format, but worry about that second. Worry about making sure the list is correct and complete first.
• The entry given below is an example of AMA format, and should not be retained.

Figures

• Each row in this table represents a figure that was not created by CDISC. The first column holds the figure number and caption as given in the current document; and the second column holds the copyright information and means/date of permission to reproduce, if applicable.
• See the TAUG Content Guide has examples.

Further Reading

• This list contains the full reference information for any works not actively cited within the document, but which might still be of interest to the reader, or were mentioned or referred to at some point in the document, or even were once cited at an earlier point in in the document's development but are not any more. If you already have a list of potential references, add them here.
• Works listed here should also use AMA format, but they are listed in alphabetical order by author, or by title if no author is known.