ADaM

Hi All,

I have a question about ADaM generation.

An attempt was made to create an ADaM using only SDTM. However, SDTM was generated without some derived variable and ADaM programming team requested the variable without any changes to the SDTM.

So, unfortunately,  we created another DB containing the derived variable. The format of DB is not SDTM.

In the end, ADaM will be generated using SDTM and seperated DB (including derived variable).

Recently one of our programmers cut and paste text from an external document to populate variables.

Here is an example.  I can see that those single quotes pasted in are odd.

Hi,  I have the variables A1HI and A1IND for a dataset ADLB which is CDISC compliant.

I get the pinnacle error AD0352, "None of A1LO, A1HI, A1LOC, or A1HIC variables is present, when A1IND is present" though I can see A1HI in the dataset.

Can you please help to resolve this.

Thank you

Hi all,

I have 2 datasets with the variable: PPFL (which has values Y or N), and the datasets are both "Occurence Data Structure". The datasets are ADAE and ADAEDEV. When I run the Pinnacle 21 validator on the transport files and define, only ADAEDEV  has the Pinnacle 21 message: "PPFL value is not Y or null", with severity = "Reject". ADAE does not have this message, not even as an error. 

Any idea why? Same exact values for PPFL, and the define identifies the datasets as both Occurence Data Structure.

Thanks!!

The AD0046 *DY = 0, issue  is firing when the *DY value has decimal places in it.  Is this a bug?  Or is there a reason why the *DY value should not have decimal places?   Some examples of my *DY value:  10.19028063, 3.59206023 and 6.53251198.

Thanks

SD1230 warning fired in  ADaM which have some missing values in AVAL and BASE. And AVAL and BASE were described as value level in define.xml.

SD1230 finding was appear as below in ADaM validation report (PMDA 1810.3 / Community Version: 3.1.1).

I have the following question,  each subject had multiple paramcd/param assessments at multiple visits,  actual visit window were assigned, when there were multiple visits in a visit window, we would have 2 different analyses, last date, or worst case.  I already had paramcd/param, avisitn/avisit, aval/avalc, basetype, dtype in the dataset, how to hold 2 different results, add new row ? add new column ?  what name can I use ? not parcat1 or avalcat1 or paramtyp. 

thanks

Hi Team,

As per the requirement of our analysis we have created the subperiods for period 2 like PxxSw, PxxSwSDT,  PxxSwSDM , PxxSwEDT and PxxSwETM in ADSL dataset as per ADaM IG 1.1 (Table 3.2.7).

Below are the variable names and Labels in the specification.

Variable Name                         Label

Hi,

I am getting AD0044 (*TM and its corresponding *DTM variable have different time values) and AD0045 (same but for *DT) flagging as an issue for datetime variables containing values prior to the year 1960 (i.e. where the underlying numeric value changes from a positive to negative in SAS using default options).

The data is an imputed date/time from a year of birth prior to 1960. The *DTM variable is needed to create a consistent method for the analysis requirements of the project, so although this doesn't seem useful it is a requirement we need to follow.

Using Pinnacle 21 Community Version: 3.1.0 I just re-validated ADaM data and the ADaM define.xml after updating the define.xml - the data has not changed. I received a new validation message that doesn't make sense: 

AD1012A "Secondary variable is present but its primary variable is not present" fired for "ABLF" (I assume for ABLFL/ABLFN as there is no variable "ABLF" present). I am using version 1.1 of the ADaM IG. Please see screenshot attached of "Details" tab of the P21 Community Validation Report.