Rule AD0196 Required ARM value is null

Sergiy

on March 12, 2021

P21

Hi Jennifer, Thank you for…

Hi Jennifer, 

Thank you for bringing attention to this issue!

Formally, current algorithm of AD0196 rule should be adjusted for FDA case as you suggested. Before doing this we need to confirm that FDA Reviewers will be OK! with it.

Per FDA, ARM should have a missing value for subjects without study ARM (e.g., Screen Failures). However, ARM is a very important variable which utilized as a primary subject treatment variable in many analysis tools on ADaM data. Therefore, FDA Reviewers may consider this AD0196 rule beneficial and may want reporting of all subjects with missing value in ARM and explanation why (e.g., "All reported subjects are Screen Failure").

Kind Regards,
Sergiy

Pinnacle validation rule AD0196

Dear Sergiy,

Regarding the Pinnacle validation rule AD0196, ARM should be an exception when ADaM is created from SDTM using SDTMIG v3.3.   Does Pinnacle 21 Community Version 3.1.2 take into account the version of SDTM that ADaM was created from?      

FDA Validator Rules v1.5 March 2021

There seems to be a conflict between the description wording of FDA validation rule SD1363 vs. (SD1363, SD1360).  These are validation rules rules written for SDTMIG v3.3.

The SD1363 description contains a double negative. "Planned Arm Code (ARMCD) and Description of Planned Arm (ARM) must not be null for subjects who are not assigned to treatment."   In order to have rule SD1363 in agreement with (SD1359 and SD1360)  logically,  it needs to be rephrased as "Planned Arm Code (ARMCD) and Description of Planned Arm (ARM) must be null for subjects who are not assigned to treatment." 

For SDTMIG v3.3 the FDA rule violation is  "ARMCD/ARM is populated for a subject not assigned to treatment."

SD1363     ARMCD/ARM is populated for a subject not assigned to treatment.    Planned Arm Code (ARMCD) and Description of Planned Arm (ARM) must not be null for subjects who are not assigned to treatment. This includes Screen Failure subjects and Not Assigned subjects.    DM domain SDTMIG v3.3

SD1359    ARMCD/ARM are populated but ARMNRS is not populated.    When Planned Arm Code (ARMCD)/Description of Planned Arm (ARM) are not populated, the Reason Arm and/or Actual Arm is Null (ARMNRS) variable must be populated with the reason ARMCD/ARM are null.    DM domain SDTMIG v3.3      

SD1360    ARMNRS is populated but ARMCD and ACTARMCD are populated.    The Reason Arm and/or Actual Arm is Null (ARMNRS) variable should only be populated when Planned Arm Code (ARMCD) and Actual Arm Code (ACTARMCD) are null.    DM domain SDTMIG v3.3           

Best Regards,

Frank Tedesco

Hurley Consulting Associates, Ltd.

25 DeForest Avenue

Summit NJ 07901

Office Phone: (908) 273-8490

Fax Number: (908) 273-2670

www.hurleyconsulting.com

Sergiy

on February 22, 2022

P21

Hi Frank,  Yes, ARM…

Hi Frank, 

Yes, ARM variable will be removed from the algorithm of AD0196 rule which will be limited to PARAM, PARAMCD, STUDYID and USUBJID.

Thank you for reminding us about this issue!

Kind Regards,
Sergiy 

Hi Sergiy,  Are there any…

Hi Sergiy, 

Are there any plans to when this will be fixed? Thank you. 

Kind Regards,

Sherry.

Sergiy

on August 18, 2022

P21

Hi Sherry,  Exception for…

Hi Sherry, 

Exception for ARM variable in AD0196 rule has been added in 2204.1 engine. It will be available in the next update of Community in the next few weeks.

Kind Regards,
Sergiy