# General **URL:** https://forum.certara.com/c/pinnacle21/general/7.md [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) --- ## [Excel spec sheet template for input to P21 community?](https://forum.certara.com/t/excel-spec-sheet-template-for-input-to-p21-community/4431)
**Author:** [@Paul\_Sanfilippo](https://forum.certara.com/u/Paul_Sanfilippo)\ **Replies:** 0\ **Last updated:** [October 15, 2026, 8:24pm UTC](https://forum.certara.com/t/excel-spec-sheet-template-for-input-to-p21-community/4431 "2026-10-15T20:24:34Z")
HI All, I’m fairly new to CDISC programming (and also coming at this from the R side of things). Im’ trying to understand best practice for creating define.xml files. I understand one can either: Create define.xml onc… --- ## [Pinnacle 21 Community 4.2.0 is here, and this one requires a manual install](https://forum.certara.com/t/pinnacle-21-community-4-2-0-is-here-and-this-one-requires-a-manual-install/4422)
**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\ **Replies:** 0\ **Last updated:** [August 13, 2026, 12:17pm UTC](https://forum.certara.com/t/pinnacle-21-community-4-2-0-is-here-and-this-one-requires-a-manual-install/4422 "2026-08-13T12:17:24Z")
Pinnacle 21 Community 4.2.0 is now available for Windows. A Mac build is on the way, and we’ll update this post as soon as it’s out. Please read before you update. Unlike previous releases, 4.2.0 will not arrive through… --- ## [About SD1344 rule](https://forum.certara.com/t/about-sd1344-rule/4410)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 3\ **Last updated:** [July 7, 2026, 7:53pm UTC](https://forum.certara.com/t/about-sd1344-rule/4410 "2026-07-07T19:53:36Z")
Hi, When the length of CM.CMCLAS exceeds $200, the data should be truncated within $200. This results in an SD1344 (Value for CMDECOD not found in WHODrug dictionary) validation finding. Could you please adjust the va… --- ## [Access Issue with Pinnacle21 Community via Proxy Network](https://forum.certara.com/t/access-issue-with-pinnacle21-community-via-proxy-network/4395)
**Author:** [@SASAKI1](https://forum.certara.com/u/SASAKI1)\ **Replies:** 1\ **Last updated:** [May 20, 2026, 1:34pm UTC](https://forum.certara.com/t/access-issue-with-pinnacle21-community-via-proxy-network/4395 "2026-05-20T13:34:39Z")
Hello, I am currently trying to use Pinnacle21 Community, but I am unable to access the service when connected through a proxy network. In my environment, outbound connections are routed via a corporate proxy for secur… --- ## [Error in P21 when generating the ADaM define](https://forum.certara.com/t/error-in-p21-when-generating-the-adam-define/4308)
**Author:** [@anantha.khandavilli](https://forum.certara.com/u/anantha.khandavilli)\ **Replies:** 14\ **Last updated:** [February 17, 2026, 10:19am UTC](https://forum.certara.com/t/error-in-p21-when-generating-the-adam-define/4308 "2026-02-17T10:19:32Z")
Hi Team, Our team was working on an ADaM define for a study and encountered the following error in P21 when generating the define using the BMS inhouse template and seeing below error. They have checked the ADaM spec bu… --- ## [INVALID ISO 8601 not throw error](https://forum.certara.com/t/invalid-iso-8601-not-throw-error/4363)
**Author:** [@Premkumar\_Prawinkuma](https://forum.certara.com/u/Premkumar_Prawinkuma)\ **Replies:** 1\ **Last updated:** [February 6, 2026, 6:45pm UTC](https://forum.certara.com/t/invalid-iso-8601-not-throw-error/4363 "2026-02-06T18:45:25Z")
Hi, i have scenario where Date is collected with YEAR and MONTH , No DAY collected , However Time collected. My program created date as 2026-02T09:00. i finally found that this is not per ISO 8601 Date format. it should… --- ## [Getting Error "Variable is in wrong order within domain"](https://forum.certara.com/t/getting-error-variable-is-in-wrong-order-within-domain/4332)
**Author:** [@jenny\_zhou](https://forum.certara.com/u/jenny_zhou)\ **Replies:** 3\ **Last updated:** [October 13, 2025, 2:09am UTC](https://forum.certara.com/t/getting-error-variable-is-in-wrong-order-within-domain/4332 "2025-10-13T02:09:49Z")
I am getting this error in many domain, ae cm dm etc. I have tried many sort sequence combination, but this issue still there and even in dm(which is sorted by studyid, usubjid) I am sure there is no duplicates. any i… --- ## [SV domain: SVOCCUR caused an error message in SDTMIG 3.3 - SD0058: Variable appears in dataset, but is not in SDTM model](https://forum.certara.com/t/sv-domain-svoccur-caused-an-error-message-in-sdtmig-3-3-sd0058-variable-appears-in-dataset-but-is-not-in-sdtm-model/4246)
**Author:** [@Linda\_Li](https://forum.certara.com/u/Linda_Li)\ **Replies:** 4\ **Last updated:** [June 17, 2025, 2:08pm UTC](https://forum.certara.com/t/sv-domain-svoccur-caused-an-error-message-in-sdtmig-3-3-sd0058-variable-appears-in-dataset-but-is-not-in-sdtm-model/4246 "2025-06-17T14:08:11Z")
Hello, I included SDTMIG 3.4 new SV domain variables SVPRESP, SVOCCUR, SVREASOC, SVCNTMOD, SVEPCHGI in the SV domain, which used the older version SDTMIG 3.3 version, and received an error message “SD0058: Variable appe… --- ## [Is P21C able to validate BIMO Package, or it can only be validated by P21E?](https://forum.certara.com/t/is-p21c-able-to-validate-bimo-package-or-it-can-only-be-validated-by-p21e/4256)
**Author:** [@Siru\_Zhou](https://forum.certara.com/u/Siru_Zhou)\ **Replies:** 1\ **Last updated:** [June 16, 2025, 1:43pm UTC](https://forum.certara.com/t/is-p21c-able-to-validate-bimo-package-or-it-can-only-be-validated-by-p21e/4256 "2025-06-16T13:43:33Z")
Is P21C able to validate BIMO Package, or it can only be validated by P21E? --- ## [Did Pinnacle 21E Check the duplicate Records on Sponsor Keys?](https://forum.certara.com/t/did-pinnacle-21e-check-the-duplicate-records-on-sponsor-keys/2112)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 0\ **Last updated:** [March 13, 2025, 6:59pm UTC](https://forum.certara.com/t/did-pinnacle-21e-check-the-duplicate-records-on-sponsor-keys/2112 "2025-03-13T18:59:05Z")
Hi PK, P21 Validator has SD1152 (Duplicate records per Key Variables in Define.xml) and several other rules for duplicate records per pre-specified Keys Vars. SD1117 for Findings domains, SD1201 for Events, SD1352 for… --- ## [Updates to our P21 "Validation Rules" list](https://forum.certara.com/t/updates-to-our-p21-validation-rules-list/4192)
**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\ **Replies:** 0\ **Last updated:** [April 28, 2025, 2:06pm UTC](https://forum.certara.com/t/updates-to-our-p21-validation-rules-list/4192 "2025-04-28T14:06:16Z")
I’m happy to share that we’ve updated our “Validation Rules” portion of our website! :tada: Aside from the visual enhancements to further align the UI with our Pinnacle 21 Enterprise product, this update also allows for… --- ## [P21-client-1.0.8 - New FDA 2405.2 Engine](https://forum.certara.com/t/p21-client-1-0-8-new-fda-2405-2-engine/4176)
**Author:** [@Ryan\_Barlow](https://forum.certara.com/u/Ryan_Barlow)\ **Replies:** 8\ **Last updated:** [April 16, 2025, 3:00pm UTC](https://forum.certara.com/t/p21-client-1-0-8-new-fda-2405-2-engine/4176 "2025-04-16T15:00:37Z")
I am just wondering when/how to update the CLI to support the new FDA 2405.2 engine, I have reinstalled and the whole of P21 community/P21 CLI and the engines.json inside "C:\\Program Files (x86)\\Pinnacle 21 Community\\res… --- ## [PMDA 2411.0 engine is available in Community now](https://forum.certara.com/t/pmda-2411-0-engine-is-available-in-community-now/4160)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 0\ **Last updated:** [April 1, 2025, 8:38pm UTC](https://forum.certara.com/t/pmda-2411-0-engine-is-available-in-community-now/4160 "2025-04-01T20:38:08Z")
PMDA 2411.0 validation engine is available in P21 Community now (2025-04-01). --- ## [PMDA published validation rules Version 6.0](https://forum.certara.com/t/pmda-published-validation-rules-version-6-0/2113)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [March 14, 2025, 2:32pm UTC](https://forum.certara.com/t/pmda-published-validation-rules-version-6-0/2113 "2025-03-14T14:32:54Z")
A major change is added support for SDTMIG 3.4 --- ## [2405.2 validation engine](https://forum.certara.com/t/2405-2-validation-engine/2101)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 20, 2025, 7:07pm UTC](https://forum.certara.com/t/2405-2-validation-engine/2101 "2025-02-20T19:07:22Z")
Hi Caroline, P21 2405.2 validation engine will be available in Community within the next few weeks. Kind Regards, Sergiy --- ## [Does Pinnacle21 Community support M-series MacOS?](https://forum.certara.com/t/does-pinnacle21-community-support-m-series-macos/2091)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 7, 2025, 7:41pm UTC](https://forum.certara.com/t/does-pinnacle21-community-support-m-series-macos/2091 "2025-02-07T19:41:21Z")
Hi Alex, I’ve never heard any complains about M-series. Most of Pinnacle 21 developers use Macs. So, I believe that you will be fine. Kind Regards, Sergiy --- ## [Using SUPP QNAM in VLM WhereClause for parent ORRES variable](https://forum.certara.com/t/using-supp-qnam-in-vlm-whereclause-for-parent-orres-variable/2090)
**Author:** [@colm.smyth](https://forum.certara.com/u/colm.smyth)\ **Replies:** 6\ **Last updated:** [January 8, 2025, 5:31pm UTC](https://forum.certara.com/t/using-supp-qnam-in-vlm-whereclause-for-parent-orres-variable/2090 "2025-01-08T17:31:29Z")
Interesting!!! But I don’t think it is correct, depending on what you want to achieve: SUPPxx is an artificial construct just because reviewers cannot distinguish between standard variables and non-standard variables (… --- ## [Does P21 crosscheck other ADaMs against ADSL?](https://forum.certara.com/t/does-p21-crosscheck-other-adams-against-adsl/2083)
**Author:** [@susan.gardner](https://forum.certara.com/u/susan.gardner)\ **Replies:** 1\ **Last updated:** [January 8, 2025, 2:53pm UTC](https://forum.certara.com/t/does-p21-crosscheck-other-adams-against-adsl/2083 "2025-01-08T14:53:56Z")
Hi Suzy, I discussed this amongst our ADaM team and confirmed the following: We only cross-check a few specific variables in this case: AGE AGEU SEX RACE SUBJID SITEID ARM ACTARM ETHNIC TRTxxP → TRTP APxxSDT, APxxSTM… --- ## [Submitting more than 1 ADSL](https://forum.certara.com/t/submitting-more-than-1-adsl/1895)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [November 27, 2024, 11:05am UTC](https://forum.certara.com/t/submitting-more-than-1-adsl/1895 "2024-11-27T11:05:13Z")
Hi Lisa, It is not clear why do you need additional ADSL dataset? In ADaM model you can add any additional variables you need for analysis. So, why just adding Natural History population Flag and other variables does no… --- ## [显示数据格式无效报错](https://forum.certara.com/t/topic/2066)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [October 2, 2024, 1:10pm UTC](https://forum.certara.com/t/topic/2066 "2024-10-02T13:10:05Z")
Hello, This post would be better suited in the Define.xml forum space, Define.xml - Certara. However, if you email community@pinnacle21.com and attach the define spec you are using, we can review the file and follow up … --- ## [显示数据格式无效报错](https://forum.certara.com/t/topic/2065)
**Author:** [@yanrong.liu](https://forum.certara.com/u/yanrong.liu)\ **Replies:** 0\ **Last updated:** [September 29, 2024, 2:22pm UTC](https://forum.certara.com/t/topic/2065 "2024-09-29T14:22:08Z")
大家好，在使用Generate Define时出现“The provided source is not a valid XSLX document”报错上传的EXCEL在其他同事上传是可以正常打开的，检查P21和EXCEL版本均是最新版本，还是出现此类问题，这种情况是什么原因导致的。 --- ## [Several versions of the Pinnacle21 Community on the same host](https://forum.certara.com/t/several-versions-of-the-pinnacle21-community-on-the-same-host/2053)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [August 20, 2024, 7:35am UTC](https://forum.certara.com/t/several-versions-of-the-pinnacle21-community-on-the-same-host/2053 "2024-08-20T07:35:50Z")
Hi Serhii, Pinnacle 21 does not support old versions of the application to ensure correct functionality of the Validator and meeting requirements from the regulatory agencies. Kind Regards, Sergiy --- ## [How to add CTs to the Pinnacle21 community version (in CLI)](https://forum.certara.com/t/how-to-add-cts-to-the-pinnacle21-community-version-in-cli/1554)
**Author:** [@aravindraj.x.aravindraj](https://forum.certara.com/u/aravindraj.x.aravindraj)\ **Replies:** 5\ **Last updated:** [August 7, 2024, 5:35am UTC](https://forum.certara.com/t/how-to-add-cts-to-the-pinnacle21-community-version-in-cli/1554 "2024-08-07T05:35:15Z")
Hi all, I want to set up CLI to validate datasets and define.xml. But I am facing a situation when the CT does not exist (has not been added) to the “configs” folder. In this case, the error occurs “CLI.3.9 \[Error code:… --- ## [Custom Terminology - Validation Rule MD0102](https://forum.certara.com/t/custom-terminology-validation-rule-md0102/2049)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [August 5, 2024, 1:45pm UTC](https://forum.certara.com/t/custom-terminology-validation-rule-md0102/2049 "2024-08-05T13:45:30Z")
Hi Lisa, This sounds related to P21 Enterprise. I will create an Enterprise Service Desk ticket for you to track this question. Kind regards, Matt --- ## [GENC COUNTRY code](https://forum.certara.com/t/genc-country-code/2037)
**Author:** [@colm.smyth](https://forum.certara.com/u/colm.smyth)\ **Replies:** 2\ **Last updated:** [June 28, 2024, 8:22am UTC](https://forum.certara.com/t/genc-country-code/2037 "2024-06-28T08:22:06Z")
Hi Colm, According to the FDA data standard catalog, “Date Requirement Begins” for GENC terminlogy is 12/17/2020. If the study began after 12/17/2020, GENC is applicable for FDA submission. And, GENC uses ISO 3166 name… --- ## [Community 4.1.0 Released](https://forum.certara.com/t/community-4-1-0-released/2020)
**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\ **Replies:** 0\ **Last updated:** [June 4, 2024, 1:22pm UTC](https://forum.certara.com/t/community-4-1-0-released/2020 "2024-06-04T13:22:20Z")
We are excited to announce the release of Pinnacle 21 Community 4.1.0. This release adds support for Dataset-JSON for both validation and data conversion. Release notes are below (and can also be found in the Help menu w… --- ## [Incompatible CLI used](https://forum.certara.com/t/incompatible-cli-used/2016)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [June 3, 2024, 3:26am UTC](https://forum.certara.com/t/incompatible-cli-used/2016 "2024-06-03T03:26:04Z")
Hello John, 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 down… --- ## [Incompatible CLI used](https://forum.certara.com/t/incompatible-cli-used/2015)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [May 31, 2024, 1:52pm UTC](https://forum.certara.com/t/incompatible-cli-used/2015 "2024-05-31T13:52:10Z")
Hello John, 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 down… --- ## [AE outcome, validation rule SD1332/FDAB034](https://forum.certara.com/t/ae-outcome-validation-rule-sd1332-fdab034/1509)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [April 3, 2024, 6:05am UTC](https://forum.certara.com/t/ae-outcome-validation-rule-sd1332-fdab034/1509 "2024-04-03T06:05:05Z")
Hi Titania, SD1332 is implementation of FDA rule. Most Adverse Events data collected as one record per event. Therefore, I assume that FDA will keep it as it. I think, this is an example of some deficiency in CDISC sta… --- ## [Update Frequency](https://forum.certara.com/t/update-frequency/1933)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [March 5, 2024, 1:23pm UTC](https://forum.certara.com/t/update-frequency/1933 "2024-03-05T13:23:46Z")
Hi Cyril, We update P21 Community based on actual needs. New engine 2304.0 will be released within the next few days or weeks. Kind Regards, Sergiy [Next page](https://forum.certara.com/c/pinnacle21/general/7.md?page=1)