RULE ID AD0041, 42 and 43 - RULE ID AD0041, 42 and 43 its not included IS8601DA, IS8601TM, and IS8601DT

v Venkata

on March 16, 2013

HI,

I raised an issue about RULE ID AD0041, 42 and 43 its not included IS8601DA, IS8601TM, and IS8601DT which were not included in the program the asnwear I got that asked me to change config.xml level - if I do the error will disapper at my level - what if we submit this adtasets to FDA and still mentioned error messages will appear.

I appreciate your view here.

Thanks and KR,

Venkata Maguluri.

Forums: Validation Rule Suggestions

m Michael

on March 20, 2013

Display Formats

I'm not sure what the official guidance is on this. These rules were based on the CDISC ADaM Validation Rules Spec and while everything is considered an error, this could probably be a warning. As long as the display format is a valid SAS format, the FDA shouldn't be concerned. Recall that the ADaM IG and Machine-Testable Failure Criteria is this:

Numeric dates, times and datetimes should be formatted so as to be human readable with no loss of precision

A variable with a suffix of DT,TM or DTM does not have a SAS Date,time or datetime format.

The problem is determining all the possible permutations of a valid SAS display format. Does anyone know where this exhausitive list resides ? Or a regular expression which captures it?

For now, feel free to add you own formats to the config and we can attempt to include these new formats into 1.4.1. When you send your reviewers guide, just explain which formats you used and that they are indeed valid It's more important that the data is stored correctly for analysis.