Clinical Data Interchange Standards Consortium
Specification for the Operational Data Model (ODM)
Version 1.3 ProductionSource File: ChangesInProductionVersion.html
Last Update: 2006-12-15
Copyright © CDISC 2006 This document is the property of CDISC Inc. This document can be freely used and reproduced without limitation as long as (1) it is not modified, and (2) the entire copyright statement is included in the copy. Modifications to this document can only be made with written consent of CDISC Inc.
An official copy of this document is available at http://www.cdisc.org/models/odm/v1.3/ChangesInProductionVersion.html.
| Comment | Author | Response | Date |
|---|---|---|---|
| Protocol defines a Description element but the schema does not allow it. | Gilles Rondeau, Integrim | Description has been added to the schema. | 2006-07-31 |
| Add optional FormalExpression tags to RangeCheck tags. This would allow checking of answers to include the answers to other questions. For example, Q1: How many children do you have?, Q2: How many of them have epilepsy? The answer to Q2 should be less than or equal to the answer to Q1. | Simon Dennison, Hybrid-4 Ltd | Added to schema and specification | 2006-05-02 |
| A new Title tag which contains TranslatedText tags linked from all Study/StudyEventDef/FormDef/ItemGroupDef/ItemDef tags | Simon Dennison, Hybrid-4 Ltd | Recommend using Description | 2006-05-02 |
| User defined Global / Local variables. For example, a questionnaire has a maximum age limit which could then be used with ConditionDef/FormalExpression | Simon Dennison, Hybrid-4 Ltd | Beyond scope of current version. | 2006-05-02 |
| The Name attribute seems to be missing from ValueList
The description and purpose of this element should be expanded to make its use more clear. Is the purpose to provide the definition of a complex Item? Something like Blood Pressure which can contain systolic and diastolic values? | Esteban Porcelli, Novartis | Removed ValueLists from ODM schema | 2006-05-02 |
| Extend ValueList concept to better support Analysis Datatasets. Need to be able to identify variable(s) where values identified in ValueLIst attached to an SDTM XXTESTCD variable are stored. | Greg Steffens | Removed ValueLists from ODM schema | 2006-05-22 |
| Support more complex relationships between codelists and variable values - so that data values could correspond CodedValues or Decodes. | Greg Steffens | Beyond scope of current version. | 2006-05-22 |
| Use codelists to capture data grouping definitions. The codelist element allows for only one code value. If you want to define age ranges that translate to decode values of "young", "adult" and "elderly" this does seem to be possible now. The RangeCheck element allows ranges but not decodes. The CodeList element allows decodes but not ranges. | Greg Steffens | Beyond scope of current version. | 2006-05-22 |
| It would be useful if the ItemDef element included an attribute that specified whether the item is allowed to be missing or not. For example, USUBJID should never be missing, but a comment variable could be allowed to have a missing value. The "mandatory" attribute specifies that the variable must exist, we need another attribute to specify the variable must have a value. | Greg Steffens | Mandatory indicates whether an the item is considered optional in the study protocol. May reconsider semantics in the future. | 2006-05-22 |
| For free-form text elements, I suggest we support formatted text. Whether it is a description of the derivation logic, or a comment, the white space in the text is important to understanding the text. If the document you are reading now was a continuous line of wrapped text without paragraphs or tables, it would be very difficult to understand! | Greg Steffens | Inconsistent with platform independent, vendor neutral mandate. | 2006-05-22 |
| Add Boolean, URL data types | Jozef Aerts, XML 4 Pharma | Added. | 2006-10 |
| Numerous clarifications needed in Specification | Kevin Burges, Formedix | Done | 2006-04 |