AD1008 - Age can have NULL values

Hi Venkata,  Age is required

Hi Venkata, 

Age is required information for analysis of clinical trial data. It can be collected either as age itself or be derived based on subject date of birth.

See ADaM and SDTM documents for details.

Regards,

Sergiy 

We have AGEIMP element

Hi,

 

Thanks alot for the reply, yes we derived AGEIMP (imputed age) , and we do submit this info in SUPP and ADSL - and we are not touching AGE element if birth date is partial - Does it okay?

 

THanks,

Venkata

It depends on how did you

It depends on how did you collect age in SDTM? In general, age is expected to be populated for all subjects in Demographics domain. Some exceptions are allowed. E.g., for Screen Failures. 

If you have Age in SDTM, then ADaM AGE variable should be a copy of Demographics AGE. If in analysis data you populate subject age by using different algorithm compare to data collection process (DM domain), then you need to introduce a new variable. E.g., AGEIMP. You may have both AGE and AGEIMP variables in ADaM.

Regards, 

Sergiy

Yes, ADSL contains AGE and AGEIMP

Dear Sergiy -

 

Thanks for the response - Yes ADSL contains AGE and AGEIMP - so does it fine if we document this in revewiers guide and ignore this Open CDISc errors?

ADSL ## AGE null AD1008 Null value in variable marked as Required Presence Error

 

Thanks again,

Venkata

I do not know all details

I do not know all details about your data collection process, study protocol and statistical analysis plan to make decission if you can ignore AD0018 error messages.

However, as I said before, in general subject Age is expected to be collected and populated in SDTM DM domain. Most likely there is something wrong if you have missing AGE (Demographics) in your ADaM data.

Regards, 

Sergiy

Thanks,

THanks a lot Sergiy...we will take a call - how to proceed.

ADSL.AGE has to match sdtm.DM.AGE exactly

and AGE is Expected. AGE is not Required in every row in SDTM, and the SDTM IG for DM.AGE derivation says "but BRTHDTC may not be available in all cases (due to subject privacy concerns)". 

So if an ADaM variable with name matching to SDTM varname is mandated to have all the same values  as DM.AGE (according to the ADaM IG), then that means ADSL.AGE can have null values for these issues.

How can it be otherwise?

Reference:
ADaM IG, pg 10: 'Any ADaM variable whose name is the same as an SDTM variable must be a copy of the SDTM variable, and its label, meaning, and values must not be modified. ADaM adheres to a principle of harmonization known as "same name, same meaning, same values."'  

Thank you,

Joan

Hi Joan,  My understanding is

Hi Joan, 

My understanding is that a SDTM AGE variable's Core value is Expected to handle Screen Failures with potentially unknown age. For randomized/treated subjects used in data analysis you must to have info about their age.

Kind Regards, 

Sergiy

ADSL.AGE challenging to DM.AGE rule

Normal 0 false false false EN-US X-NONE X-NONE

Hi Sergiy,

I absolutely agree with Joan.

 

 

DM.AGE rule allows NULL values and it’s direct copy element for ADSL from DM domain but it’s expected to have partial dates for subjects who randomized/ assigned treatments ( it subject call to provide info or not about birth date – and that’s the reason we do create imputed age by imputing birth date to check the IE criteria’s)

– ADSL.AGE should allow null values.

 

Venkata Maguluri