1. Demystifying Define.xml Codelists for Nonclinical Studies
2018 CSS Project Update

2. Demystifying Define.xml Codelists for Nonclinical Studies
Goals of the project:
Provide best-practice recommendations for specific problems/questions encountered when completing the define.xml codelist section for a nonclinical study
Project status:
Ongoing, and to continue as a project in 2018
Ambitions and/or Accomplishments
Created and prioritized a list of questions/issues/challenges/concerns related to nonclinical codelists within the define-XML standard
Started investigating the top priority items
Current plan is to put best-practice recommendations on:
the SEND Implementation Wiki, Define Fundamental page
the SEND Implementation Wiki, FAQ page Define-XML section
Contacts: Jennifer Feldmann Kathy Brown
Link to Project WIKI

3. Demystifying Define.xml Codelists for Nonclinical Studies
Priority Questions:
How is define.xml currently used by FDA, sponsors, CROs, vendors? What are the possible uses for define.xml in nonclinical?
Which variables, other than those associated with CDISC published CT, should have codelists? What are the criteria for determining this?
What terms should be included in a codelist? What are the criteria to determine this for each variable?
When should CodeListItem be used and when should EnumeratedItem be be used in a codelist? When CodelistItem is used, what should be in decode?
When can a codelist be shared by multiple variables?
Other Questions:
How should user-defined codelists be named?
How should subsets of CDISC published codelists be named?
If a term is entered as free text during data collection (i.e., it was not predefined) is it represented in the codelist any differently than the predefined terms?

4. Visual for project