# SEND **URL:** https://forum.certara.com/c/pinnacle21/support/send/18.md [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) --- ## [About the SEND category](https://forum.certara.com/t/about-the-send-category/2128)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 0\ **Last updated:** [March 24, 2025, 2:26am UTC](https://forum.certara.com/t/about-the-send-category/2128 "2025-03-24T02:26:19Z")
--- ## [CV domain dataset label value](https://forum.certara.com/t/cv-domain-dataset-label-value/4369)
**Author:** [@SASAKI1](https://forum.certara.com/u/SASAKI1)\ **Replies:** 3\ **Last updated:** [March 10, 2026, 3:36pm UTC](https://forum.certara.com/t/cv-domain-dataset-label-value/4369 "2026-03-10T15:36:06Z")
After updating the engine and running validation on the define file only, the following issue was raised regarding the dataset label. In accordance with the SEND IG, we set the label of the CV domain to “Cardiovascular”… --- ## [SE2366 - TX - Invalid value for TXVAL for TRTDOS - SEND](https://forum.certara.com/t/se2366-tx-invalid-value-for-txval-for-trtdos-send/2109)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [March 11, 2025, 5:08pm UTC](https://forum.certara.com/t/se2366-tx-invalid-value-for-txval-for-trtdos-send/2109 "2025-03-11T17:08:29Z")
Hi Matteo, Please see rule Description in your validation report: RuleID: SE2366 Publisher ID: 240.1 (CDISC SEND) Message: Invalid value for TXVAL for TRTDOS Description: TXVAL value must be a number, a semicolon-d… --- ## [TX Domain Warning: "Invalid value for TXVAL for TRTDOS" when TRTDOS = 0](https://forum.certara.com/t/tx-domain-warning-invalid-value-for-txval-for-trtdos-when-trtdos-0/2055)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 7, 2025, 7:59pm UTC](https://forum.certara.com/t/tx-domain-warning-invalid-value-for-txval-for-trtdos-when-trtdos-0/2055 "2025-02-07T19:59:39Z")
Hi Adam, This rule was updated just after release of 2304.3 engine. New upcoming Community engine 2405.2 will not report “0” value as an issue. Sorry for inconvenience. Kind Regards, Sergiy --- ## [SEND requirement for dermal tolerability study](https://forum.certara.com/t/send-requirement-for-dermal-tolerability-study/2059)
**Author:** [@umang.varia](https://forum.certara.com/u/umang.varia)\ **Replies:** 2\ **Last updated:** [September 9, 2024, 6:34am UTC](https://forum.certara.com/t/send-requirement-for-dermal-tolerability-study/2059 "2024-09-09T06:34:23Z")
Dear Umang, This question has nothing to do with Pinnacle21, so I would not be surprised when you never receive an answer from them. A much better place to post this question is on LinkedIn, where there is a “CDISC” di… --- ## [DD0073: Invalid Origin Type value](https://forum.certara.com/t/dd0073-invalid-origin-type-value/2030)
**Author:** [@qianqian.lv](https://forum.certara.com/u/qianqian.lv)\ **Replies:** 0\ **Last updated:** [June 20, 2024, 8:01am UTC](https://forum.certara.com/t/dd0073-invalid-origin-type-value/2030 "2024-06-20T08:01:11Z")
Hi Team, I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of ‘CRF’, ‘Derived’, ‘Assigned’, ‘Protocol’, ‘eDT’, o… --- ## [Problem in P21C validation report: Incompatible CLI used](https://forum.certara.com/t/problem-in-p21c-validation-report-incompatible-cli-used/2017)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [June 1, 2024, 3:52am UTC](https://forum.certara.com/t/problem-in-p21c-validation-report-incompatible-cli-used/2017 "2024-06-01T03:52:24Z")
Hello Cuimin, We have just released P21 Community v4.1.0 with an updated CLI .jar file (1.0.8). If your application is online, you will get prompted to Auto-Update the next time you open Community. If offline, please do… --- ## [community cli](https://forum.certara.com/t/community-cli/1950)
**Author:** [@kwabena.amo](https://forum.certara.com/u/kwabena.amo)\ **Replies:** 2\ **Last updated:** [July 13, 2023, 6:32pm UTC](https://forum.certara.com/t/community-cli/1950 "2023-07-13T18:32:15Z")
Update to post above I believe the cli process fails from this point with this error: 2023-07-11 17:47:51 \[main\] ERROR n.b.api.monitor.segment.Segments - Segments failed java.lang.NullPointerException: null at net.bo… --- ## [FDA Validation Rules 1.6](https://forum.certara.com/t/fda-validation-rules-1-6/1922)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [May 17, 2023, 7:35am UTC](https://forum.certara.com/t/fda-validation-rules-1-6/1922 "2023-05-17T07:35:07Z")
Hi Michael, Yes, P21 engine 2204.1 (FDA) covers FDA rules v1.6. What documentation are you looking for? Thank you, Sergiy --- ## [SEND DART 1.1 and 3.1.1 Rules](https://forum.certara.com/t/send-dart-1-1-and-3-1-1-rules/1787)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 28, 2022, 7:11pm UTC](https://forum.certara.com/t/send-dart-1-1-and-3-1-1-rules/1787 "2022-02-28T19:11:06Z")
Hi Jason, Support for DART, AR and SEND-IG 3.1.1 will be available soon in the next release on Community engine. Kind Regards, Sergiy --- ## [Validation rule 1736](https://forum.certara.com/t/validation-rule-1736/1774)
**Author:** [@umang.varia](https://forum.certara.com/u/umang.varia)\ **Replies:** 0\ **Last updated:** [January 4, 2022, 9:24am UTC](https://forum.certara.com/t/validation-rule-1736/1774 "2022-01-04T09:24:40Z")
I have created simplified TS.xpt because study started before 17th Dec 2016. but regulatory colleague has received FDA Technical rejection Error 1736 that describe that we have to submit dm.xpt and define.xml. Because of… --- ## [Recording of P21 webinar: How We Improved the SEND Validation Rules](https://forum.certara.com/t/recording-of-p21-webinar-how-we-improved-the-send-validation-rules/1762)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 0\ **Last updated:** [December 8, 2021, 5:42pm UTC](https://forum.certara.com/t/recording-of-p21-webinar-how-we-improved-the-send-validation-rules/1762 "2021-12-08T17:42:35Z")
Just in case if anybody missed this webinar https://www.youtube.com/watch?v=o-qjjaeHoqw --- ## [no Warnings and Errors severity level in validator report (version 3.1.0)](https://forum.certara.com/t/no-warnings-and-errors-severity-level-in-validator-report-version-3-1-0/1616)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 9\ **Last updated:** [August 23, 2021, 9:31am UTC](https://forum.certara.com/t/no-warnings-and-errors-severity-level-in-validator-report-version-3-1-0/1616 "2021-08-23T09:31:39Z")
Hi Amparo, A while ago, FDA stopped using Severity for their validation rules. They concern that some users ignore Warnings. However, all validation issues are important. That’s why now you can see only FDA Reject Sever… --- ## [SD1149- Expected variable with missing value for all records](https://forum.certara.com/t/sd1149-expected-variable-with-missing-value-for-all-records/1727)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [August 23, 2021, 4:29am UTC](https://forum.certara.com/t/sd1149-expected-variable-with-missing-value-for-all-records/1727 "2021-08-23T04:29:22Z")
Hi Umang, This is a new rule from CDISC teams (SDTM - CG0016 and SEND - #14). ‘We consider it as a Notice message which requires manual confirmation that there is nothing wrong in your case. You need to document your s… --- ## [SE2326 message populated for 3.0 dataset](https://forum.certara.com/t/se2326-message-populated-for-3-0-dataset/1719)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [July 13, 2021, 8:01pm UTC](https://forum.certara.com/t/se2326-message-populated-for-3-0-dataset/1719 "2021-07-13T20:01:21Z")
Hi, A missing value in TSVAL and ‘NA’ in TSVALNFL. Also, TSVCDREF=‘ISO 21090’. Kind Regards, Sergiy --- ## [FDA Validator Rules Version](https://forum.certara.com/t/fda-validator-rules-version/1699)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [May 19, 2021, 1:21am UTC](https://forum.certara.com/t/fda-validator-rules-version/1699 "2021-05-19T01:21:04Z")
Hi Debra, FDA Validation Rules v1.5 are based on Pinnacle 21 Validation Engine 2010.1. Validation rules are implementation of Business Rules. Kind Regards, Sergiy --- ## [SD1079, Publisher ID 48](https://forum.certara.com/t/sd1079-publisher-id-48/1687)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [April 26, 2021, 12:28pm UTC](https://forum.certara.com/t/sd1079-publisher-id-48/1687 "2021-04-26T12:28:17Z")
Hi Debra, I believe that to avoid confusions, CDISC team needs to fix SEND-IG according to SDTM Model. Implementation Guide should be compliant with Model. Kind Regards, Sergiy --- ## [SD1138 not listed in FDA Validator Rules v1.3](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [April 22, 2021, 2:57pm UTC](https://forum.certara.com/t/sd1138-not-listed-in-fda-validator-rules-v1-3/1630 "2021-04-22T14:57:34Z")
Hi Nari, SD1128 is CDISC rule CG0348. FDA does not publish standard compliance rules. Kind Regards, Sergiy --- ## [SD1149: how to state data was not collected in the define.xml](https://forum.certara.com/t/sd1149-how-to-state-data-was-not-collected-in-the-define-xml/1679)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [April 14, 2021, 11:01am UTC](https://forum.certara.com/t/sd1149-how-to-state-data-was-not-collected-in-the-define-xml/1679 "2021-04-14T11:01:32Z")
Hi Amparo, First, you need to create your comments in “Comments” tab. Then use ID from this tab for Comment column in other tabs (e.g., Variables, Dataset, Value Level) as a link to your comment. My general recommendat… --- ## [Pinnacle 21 community warning](https://forum.certara.com/t/pinnacle-21-community-warning/1608)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [October 28, 2020, 7:19pm UTC](https://forum.certara.com/t/pinnacle-21-community-warning/1608 "2020-10-28T19:19:37Z")
Hi Umang, Pinnacle 21 provides study data validation for regulatory submissions to FDA, PMDA and NMPA. Each agency has their own additional requirements. For your example please refer to FDA Study Data Technical Conform… --- ## [STF (study tagging file)](https://forum.certara.com/t/stf-study-tagging-file/1603)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [October 28, 2020, 6:40am UTC](https://forum.certara.com/t/stf-study-tagging-file/1603 "2020-10-28T06:40:36Z")
Hi Umang, Why do you need this? Usually STF files are created by Regulatory team during compiling eCTD submission package. Thanks, Sergiy --- ## [No internet connection](https://forum.certara.com/t/no-internet-connection/1578)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [September 11, 2020, 1:47pm UTC](https://forum.certara.com/t/no-internet-connection/1578 "2020-09-11T13:47:32Z")
Hi Navin, I think that it’s due to firewall settings in your organization. Please contact your IT team. Kind Regards, Sergiy --- ## [Conflicting rule definition and error message rule FDA-SE2306 and differ between FDA and P21 publications](https://forum.certara.com/t/conflicting-rule-definition-and-error-message-rule-fda-se2306-and-differ-between-fda-and-p21-publications/1542)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [June 26, 2020, 5:23am UTC](https://forum.certara.com/t/conflicting-rule-definition-and-error-message-rule-fda-se2306-and-differ-between-fda-and-p21-publications/1542 "2020-06-26T05:23:20Z")
Hi Jozef, Please see our recent webinar https://www.pinnacle21.com/blog/how-we-improved-send-validation-rules Slide #13 or recorded webinar https://www.youtube.com/watch?v=o-qjjaeHoqw&feature=youtu.be&t=682 Kind Regar… --- ## [Non standard terminology not detected by pinnacle21 community](https://forum.certara.com/t/non-standard-terminology-not-detected-by-pinnacle21-community/1518)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [June 2, 2020, 3:29pm UTC](https://forum.certara.com/t/non-standard-terminology-not-detected-by-pinnacle21-community/1518 "2020-06-02T15:29:32Z")
Hi Umang, Could you provide more details? What variables and non-standard terms do you refer to? Are you sure that the new version of CT (2020-03-27) is downloaded to your computer? Do you have internet access and log … --- ## [Issue about "Variable length is too long for actual data"](https://forum.certara.com/t/issue-about-variable-length-is-too-long-for-actual-data/1464)
**Author:** [@amparo.pan](https://forum.certara.com/u/amparo.pan)\ **Replies:** 5\ **Last updated:** [December 17, 2019, 6:33am UTC](https://forum.certara.com/t/issue-about-variable-length-is-too-long-for-actual-data/1464 "2019-12-17T06:33:35Z")
Hi Amparo, What is the LONGEST string length of QLABEL in your dataset? Just look for the longest string for QLABEL, and then count the number of characters without the blanks at the end. That should also be the field … --- ## [Fix for Warnings in the EG domain (SEND 3.0)](https://forum.certara.com/t/fix-for-warnings-in-the-eg-domain-send-3-0/1323)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 0\ **Last updated:** [May 24, 2019, 5:40pm UTC](https://forum.certara.com/t/fix-for-warnings-in-the-eg-domain-send-3-0/1323 "2019-05-24T17:40:08Z")
Hi, I’m curious if we could get a fix (or explanation) for a few validation issues we’ve spotted in the EG domain for SEND 3.0. Specifically, the two identified are below: “Variable is in wrong order within domain” f… --- ## [SENDIG v3.1](https://forum.certara.com/t/sendig-v3-1/1205)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [May 3, 2019, 2:46pm UTC](https://forum.certara.com/t/sendig-v3-1/1205 "2019-05-03T14:46:29Z")
Community 3.0 includes support for SEND IG 3.1. The release date is early May. --- ## [SD1087/FDAN128](https://forum.certara.com/t/sd1087-fdan128/1277)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [April 9, 2019, 9:11am UTC](https://forum.certara.com/t/sd1087-fdan128/1277 "2019-04-09T09:11:00Z")
Hi Amparo, Pinnacle 21 Community 2.2.0 is quite outdated. SD1087, 91 and 92 rules were not assigned to SE domain in this version. Please wait for release of new version. To view all rules assigned to particular domain,… --- ## [2018-09-28 and 2018-12-21 P21 CT file issues](https://forum.certara.com/t/2018-09-28-and-2018-12-21-p21-ct-file-issues/1263)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [January 16, 2019, 3:45pm UTC](https://forum.certara.com/t/2018-09-28-and-2018-12-21-p21-ct-file-issues/1263 "2019-01-16T15:45:12Z")
Hi Brian, I confirm this issue. CT files will be fixed today. Thank you, Sergiy --- ## [FDA's Validation Rules version](https://forum.certara.com/t/fdas-validation-rules-version/1240)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [November 14, 2018, 3:44pm UTC](https://forum.certara.com/t/fdas-validation-rules-version/1240 "2018-11-14T15:44:40Z")
Hi Jack, Please see our blog post. Kind Regards, Sergiy [Next page](https://forum.certara.com/c/pinnacle21/support/send/18.md?page=1)