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Pinnacle21 v3.0.0 -> SD1230 (FDAB035) Value level datatype must match the datatype described in define.xml.

m Manolya
 on May 22, 2019

 

Hi!

There is a new rule in the P21 v3.0.0 community version which requires a match of the VL datatype with the datatype described in define.xml. We have some missing values in AVAL (datatype described as integer) and we get a lot of errors because we have missing AVALs. AVAL is set to Mandatory = "No".  We did not have this issue before.

furthermore, if we have a Value Level Metadata on Dates (such as ADT, ATM), this error also pops when date or time is missing. ADT/ATM are set to "integer" and Mandatory = "No" with a format of DATE9/TIME5.. So not sure why missings are not recognized.

For all the cases above the datatypes are matching between dataset and define.

 

Thank you!

Manolya

Forums: ADaM

r Ruiting
on August 5, 2019

Hi,

I see the same error message using V3.0 when AVAL has NULL values in parameter value level metadata (only for AVAL but not for other variables). I haven't seen this issue before. Can anyone help us check this? Any suggestions are greatly appreciated. Thanks very much for your help in advance.

Regards,

Ruiting

Trevor
on August 7, 2019
P21

Hi,

I can confirm that we have a ticket for this already in our internal issue tracking system. It will be fixed in the near future.

Thank you,

Trevor
Product Manager

v venkata
on March 26, 2020

HI,

 

I get the similar error

AVAL datatype is not float when PARAMCD ==

AVAL datatype is not integer when PARAMCD == 

The reason being having missing AVAL.

Is it fine to justify it in ADRG?

 

KR, Venkat

 

 

j Jeroen
on November 20, 2020

Hi, 

False positives are still being reported during ADaM validation with the latest FDA engine 1907.2 on updated P21C version 3.1.0.

When will this issue get resolved?

Kind regards,
Jeroen 

Sergiy
on November 20, 2020
P21

Hi Jeroen, 

The previous week I also found this bug and have fixed it. Corrected version of the rule will be available in the next engine release (v.2010.1).

Sorry for inconvenience.

Kind Regards,
Sergiy

j Jeroen
on November 26, 2020

Thank you, Sergiy!

Any idea when this new engine will get released?

In addition, when will P21C support validation of ADAM-IG 1.2? Official documentation has been released by CDISC quite some time ago; however, this standard is not yet mentioned in the FDA study data standards catalog.

Similar question for define.xml 2.1, which is being supported by FDA as of 15MAR2021? 

Kind regards, Jeroen 

Sergiy
on December 8, 2020
P21

Hi Jeroen, 

So far, ADaM-IG 1.2 is not accepted by any regulatory agency. It is still not included even as planned version into FDA Data Standards Catalog. Therefore, ADaM-IG 1.2 will be added into Pinnacle 21 Community as soon as regulatory agencies start supporting it. Validation of ADaM-IG 1.2 was implemented a while ago and available in Enterprise as custom P21 engine.

Similar, support for Define-XML 2.1 will be available after FDA start accepting it.

Kind Regards,
Sergiy 

j Jozef
on December 9, 2020

I presume Sergiy means "Define-XML 2.1" instead of "Define-XML 1.2". The latter has never existed.

y Ying
on February 1, 2021

Hi Sergiy,

I would like to ask when engine V.2010.1 will be released.

Thanks.

Ying

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