CDISC 3.1.2
From sasCommunity
Wednesday, August 15, 2007
| Attribute Differences |
I did some preliminary attribute comparisons between the SDTM as specified in the guidelines for 3.1.1 and compare that to 3.1.2. The template for 3.1.1 is still in development so there is room for improvements. I was using the CDISC Builder tool to perform this evaluation and had the following discoveries.
SDTMIG 3.1.1
A full detailed difference test can be viewed but among some of the findings include differences between the lengths and labels such as:
SDTMIG 3.1.2
I then compared differences just within the new 3.1.2 and found some differences. The detailed report is available. In my case, I just found an in consistent label between variables as in:
SDTMIG 3.1.1 and 3.1.2
A comparison between the 3.1.1 and 3.1.2 is available in a detailed report. Some of the findings include label differences include:
I will plan to summarize these and send it in for suggestions. Since this is in draft mode, I hope they will incorporate these changes into the final version to make things more consistent.
Posted by Sy Truong at 1:08 PM
| What's New with Version 3.1.2 |
Version Numbers
The CDISC Submission Data Standards team has currently made a draft version of the SDTM Implementation Guide 3.1.2 available for review. Note that the implementation guide has version 3.1.2 but the actual SDTM model is going to be 1.2. The implementation guide for version 3.1.1 did not really make this clear distinction since it was intended for SDTM 1.1. So the version numbers pertain to the data model which is different from the implementation guide. We therefore have:
+ SDTM 1.1 - Implementation Guide 3.1.1
+ SDTM 1.2 – Implementation Guide 3.1.2
In attempts to make the distinction, CDISC has added some nice acronyms such as: SDTMIG Version 3.1.2 for the “Implementation Guide” and SDTM v1.2 for the actual study data model.
Downloads
Downloads are sprinkled across the many pages of pages of the CDISC website. The Technical Roadmap page does help but it still drills down to other pages before you get to the download. I will therefore have the links directly listed here. Some of them pertain to 3.1.1 since these are not yet final so I am going to include them in this "3.1.2" collection.
+ SDTMIG V3.1.2 and SDTM V1.2 Review Package - Draft SDTM 1.2 Guidelines and templates forms for comments
+ Metadata Submission Guidelines, Appendix to the SDTM IG V3.1.1 - Sample transport datasets with accompanying define.xml
+ Trial Designer Model Part 2 – Trial Designer model updates to part 1
What’s New in 3.1.2
Note that we looking at the data model of SDTM v1.1 moving towards v1.2 and not to be confused with the implementation guides which is going from 3.1.1 to 3.1.2. In this case, the documented changes from SDTM 1.1 to 1.2 are listed as follows:
+ Deleted detailed history of prior versions in Section 1.1
+ Removed “*” references to controlled terminology; controlled terminology now specified in implementation guides.
+ Minor corrections to definitions of Interventions and Findings general classes in Section 2.2.
+ Added new qualifier variable --PRESP to list of qualifiers in Table 2.2.1 and 2.2.2.
+ Added new qualifier variables --VAMT and --VAMTU in Table 2.2.1.
+ Added new qualifier variable --OBJ in table 2.2.3.
+ Added new timing variables --STRTPT, --ENRTPT, --STTPT, --ENTPT to Table 2.2.5.
+ Reclassified variables RFSTDTC and RFENDTC as Qualifiers in Table 2.2.6.
+ Shifted order of variables in Table 2.2.7 (CODTC now appears last).
+ Moved Subject Elements and Subject Visits tables from Section 3 to Section 2 (Tables 2.2.8 and 2.2.9).
+ Shifted order of variables in Table 3.2.3 (VISITNUM now appears third).
+ Added TIVERS to Table 3.3.1.
+ Added TSGRPID to table 3.4.1.
+ Minor corrections and clarifications to descriptions or examples in Tables for consistency with SDTMIG. In some cases, certain implementation details that were more suited to the implementation guides have been removed.
+ Several clarifications to text and typographical errors corrected throughout.
Related Links:
Posted by Sy Truong at 10:06 AM
