The team has identified 5 priority questions about codelists that the team will research and provide 'best practice' recommendations; those questions are listed below.
The questions with recommendations are shown above in bold text.
The goal of this project is to provide recommendations for specific problems/questions encountered, when fulfilling the define.xml codelist section for a nonclinical study.
The project will be initiated by defining a specific list of issues/concerns/questions/challenges related to nonclinical codelist in define.xml to be explored.
It will then include an exploration of published general information (clinical or nonclinical) about implementing codelists in define.xml and relating this to specific challenges expressed by nonclinical data stakeholders. It will also include exploration of how codelists are used by the FDA as a consumer of the nonclinical define.xml file.
The result of this project is expected to be recommendations to the public on best practices for fulfilling codelist section of the define.xml for SEND study submissions.
Deliverables are expected to be poster(s) for the 2018 CSS; published recommendation on the SEND Implementation Wiki and a white paper may be warranted as well.
This project will not include education in the define-xml standard, generally how to create define.xml files, or any survey or analysis of define-xml tools. It will focus solely on codelist content. Participants should have a working knowledge of the define-xml standard.
The following questions and recommendations have been posted to the [Nonclinical Implementation FAQ, Define.XML Section.]:
See SENDIG 3.1 Section 4.3.4 regarding use of coded result values in SEND datasets.
|CDISC Define-XML Specification Version 2.0|
CDISC Define.xml Implementation Wiki - Working with Controlled Terminology
FDA Study Data Business Rules
Note specifically FDAB035 The definition of datasets, variables, and codelists in define.xml should reflect the actual study data.
Understanding the define.xml File and Converting It to a Relational Database
Lex Jansen, Octagon Research Solutions, Wayne, PA
SAS Global Forum 2010
PharmaSUG 2016 - Paper DS16 Codelists Here, Versions There, Controlled Terminology Everywhere
Shelley Dunn, Regulus Therapeutics, San Diego, California
From the November 2017 Study Data Technical Conformance Guide: "For variables for which no standard terms exists, or if the available terminology is insufficient, the sponsor should propose its own terms. The sponsor should provide this information in the define.xml file and in the SDRG."
|From CDISC Define-XML Specification Version 2.0, Section 4.3|
The term “Controlled Terminology” in the context of a study refers to the set of all allowable values across all variables that have finite sets of allowable values in the study. A “Codelist” is a unique subset of the controlled terminology to which one or more variables are subject. Beginning with SDTM Version 1.2, the SDTM-IG requires controlled terminology for many SDTM variables. For some variables, sponsor-specific controlled terminology is recommended. All controlled terminology used in a study must be provided within the Define-XML document. Each codelist referenced by a study item shall be represented in the Define-XML document using a CodeList element.
|Questions about Define.xml Codelist|
A. General Questions to Address
4. How should published CDISC CT codelists associated with multiple variables be referenced in define.xml (UNIT, NY for example)? More specifically, when can a codelist be shared across multiple variables and when should a unique codelist be referenced?
5. Is there any specific naming convention that should be used for codelists? Are there any restrictions on naming (special characters)?
6. When should a Display Value (Decode) be included with each codelist term? Codelist entries that have a decode are included in the define.xml with CodeListItem rather than EnumeratedItem
7. If a term is entered via free text during data collection (i.e., it was not an "allowable" term predefined for selection) is it represented in the codelist any different than terms that were in an allowable list?
|Use Cases for Codelists in a Nonclinical Define.xml|
1. To see what codes, terms and acronyms mean.