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:

Base	C:\cdisc\data_3.1.1_template	DM	armcd	C	8*	Planned Arm Code*
Compare	C:\cdisc\data_3.1.1_template	TA	armcd	C	7*	Arm Code*
Base	C:\cdisc\data_3.1.1_template	DM	arm	C	14*	Description of Planned Arm*
Compare	C:\cdisc\data_3.1.1_template	TA	arm	C	10*	Description of Arm*

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:

	Data Path	Data Name	Variable	Type	Length	Label
Base	C:\cdisc\data_3.1.2	SV	visitnum	N	8	Visit Number*
Compare	C:\cdisc\data_3.1.2	TV	visitnum	N	8	Visit Sequence Number*

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:

Base	C:\cdisc\data_3.1.1_template	DM	age	N	8	Age in AGEU at RFSTDTC*
Compare	C:\cdisc\data_3.1.2	DM	age	N	8	Age*

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.