# SD1138 not listed in FDA Validator Rules v1.3

**URL:** <https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630>\
**Category:** SEND\
**Created:** [December 7, 2020, 8:54am UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630 "2020-12-07T08:54:50Z")\
**Posts on this page:** 5\
**Page:** 1

<div class="post-metadata">

**Author:** ![Sergiy](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/sergiy/32/2553_2.png) [@Sergiy](https://forum.certara.com/u/Sergiy)\
**Post date:** [December 7, 2020, 1:10pm UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630/1 "2020-12-07T13:10:11Z")

</div>

Hi Nari,

SD1128 is CDISC rule CG0348. FDA does not publish standard compliance rules.

Kind Regards,

Sergiy

---

<div class="post-metadata">

**Author:** ![michael.denieu](https://avatars.discourse-cdn.com/v4/letter/m/82dd89/32.png) [@michael.denieu](https://forum.certara.com/u/michael.denieu)\
**Post date:** [March 31, 2021, 2:35pm UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630/2 "2021-03-31T14:35:12Z")

</div>

Hi Sergiy,

I understand the application of this rule to clinical data as it is part of the CDISC SDTM conformance rules, however it is not a SEND conformance rule. Further, this is directly contradicted by the example of its usage in the 3.1 SENDIG (see below row 4). It seems inappropriate to apply this rule to SEND validation. ![SENDIG example part 1.png](https://us1.discourse-cdn.com/certara/original/1X/7e753f9f14461f12c35274f6e76ecba180a6b387.png) ![SENDIG example part 2.png](https://us1.discourse-cdn.com/certara/original/1X/9cdb5d1db26710cf8f2fa25564ee059fcde4f270.png)

---

<div class="post-metadata">

**Author:** ![Sergiy](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/sergiy/32/2553_2.png) [@Sergiy](https://forum.certara.com/u/Sergiy)\
**Post date:** [March 31, 2021, 10:33pm UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630/3 "2021-03-31T22:33:30Z")

</div>

Hi Michael,

Thank you for reporting this!

We are updating SEND validation by removing SD1038 rule.

Kind Regards,  
Sergiy

---

<div class="post-metadata">

**Author:** ![system](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/system/32/17_2.png) [@system](https://forum.certara.com/u/system)\
**Post date:** [April 22, 2021, 2:57pm UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630/4 "2021-04-22T14:57:34Z")

</div>

This is removal of rule SD1138, not SD1038, correct?

---

<div class="post-metadata">

**Author:** ![system](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/system/32/17_2.png) [@system](https://forum.certara.com/u/system)\
**Post date:** [December 7, 2020, 8:54am UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630/5 "2020-12-07T08:54:50Z")

</div>

hi,

SD1138 is not listed in FDA Validator Rules v1.3, but has been validated in the validation report.  
Could you tell me why SD1138 is verified?

Sincerely,

 ![fda-Validator-Rules_v1.3.png](https://us1.discourse-cdn.com/certara/original/1X/77934f0876db98a2598990a29fe2a2e81c5e6a27.png) ![P21_Validator_Report.png](https://us1.discourse-cdn.com/certara/original/1X/41977e551c830cbc27976518485466c4e941211b.png)
