# Product Suggestions **URL:** https://forum.certara.com/c/pinnacle21/product-suggestions/8.md [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) --- ## [About SD1439, SD1445 rule](https://forum.certara.com/t/about-sd1439-sd1445-rule/4393)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 3\ **Last updated:** [October 22, 2026, 7:01am UTC](https://forum.certara.com/t/about-sd1439-sd1445-rule/4393 "2026-10-22T07:01:03Z")
Hi, Please add the ISTSTOPO key to validation rule ID SD1439, SD1445. The Binding Antidrug Antibody ISTEST includes results for the screening, confirmatory, and titer (ISTSTOPO). Although there are no duplicate cases, … --- ## [Enable CCLI in unix-like system](https://forum.certara.com/t/enable-ccli-in-unix-like-system/4333)
**Author:** [@flight](https://forum.certara.com/u/flight)\ **Replies:** 0\ **Last updated:** [October 11, 2025, 9:26am UTC](https://forum.certara.com/t/enable-ccli-in-unix-like-system/4333 "2025-10-11T09:26:32Z")
Hi Team, it would be very grateful if we can use CCLI in linux system in next release. Best, --- ## [Diagnosis Group in TS domain](https://forum.certara.com/t/diagnosis-group-in-ts-domain/4311)
**Author:** [@Siru\_Zhou](https://forum.certara.com/u/Siru_Zhou)\ **Replies:** 1\ **Last updated:** [August 4, 2025, 8:27pm UTC](https://forum.certara.com/t/diagnosis-group-in-ts-domain/4311 "2025-08-04T20:27:05Z")
One of the TS domain Validation rule is : IF healthy volunteers = “N” then TDIGRP must be present and not null. Here is a phase 1 study, the population is Subjects with Mild and Moderate Hepatic Impairment , and the obje… --- ## [Engine FDA (2405.2) Potential Validation Bugs](https://forum.certara.com/t/engine-fda-2405-2-potential-validation-bugs/4257)
**Author:** [@harald.goldner](https://forum.certara.com/u/harald.goldner)\ **Replies:** 1\ **Last updated:** [June 16, 2025, 3:45pm UTC](https://forum.certara.com/t/engine-fda-2405-2-potential-validation-bugs/4257 "2025-06-16T15:45:33Z")
Hi there, I just wanted to bring to attention that recently performed some Validations on SDTM-IG 3.2 (FDA) as well as SDTM-IG 3.4 (FDA) where encountered 2 validation findings which I would consider bugs. (1) CT2002: … --- ## [ADNCA.PCSTRESU codelist](https://forum.certara.com/t/adnca-pcstresu-codelist/4242)
**Author:** [@john.chen](https://forum.certara.com/u/john.chen)\ **Replies:** 1\ **Last updated:** [June 6, 2025, 2:41pm UTC](https://forum.certara.com/t/adnca-pcstresu-codelist/4242 "2025-06-06T14:41:10Z")
Hi, When I ran the validation for the ADaM define file alone, the following two messages were returned: Term/NCI Code mismatch in Codelist ‘PK Units of Measure (PC)’ NCI Code ‘C85494’ for Codelist ‘PK Units of Measu… --- ## [Clarification on the BLFL Warnings with Introduction on LOBXFL](https://forum.certara.com/t/clarification-on-the-blfl-warnings-with-introduction-on-lobxfl/2105)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [March 11, 2025, 1:33am UTC](https://forum.certara.com/t/clarification-on-the-blfl-warnings-with-introduction-on-lobxfl/2105 "2025-03-11T01:33:29Z")
Hi Sri, Our approach is to keep rules for any data structure where they are potentially applicable per Model. For example, SD0006 (No baseline flag record in domain for subject) looks like been retired in SDTMIG 3.3+ d… --- ## [SD1230 and float values](https://forum.certara.com/t/sd1230-and-float-values/2093)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 11, 2025, 3:21pm UTC](https://forum.certara.com/t/sd1230-and-float-values/2093 "2025-02-11T15:21:53Z")
Hi Ryan, Thank you for reporting this issue. Its fix will be available in a new 2405.2 engine with the expected release within a month. Kind Regards, Sergiy --- ## [BM0011: Invalid value for FINLDISC variable](https://forum.certara.com/t/bm0011-invalid-value-for-finldisc-variable/1935)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [June 13, 2024, 8:57pm UTC](https://forum.certara.com/t/bm0011-invalid-value-for-finldisc-variable/1935 "2024-06-13T20:57:47Z")
Hi Lijie, In 2304.0 engine, terms for FINLDISC variable are “\>= $25,000”, “\< $25,000”, “unknown” and “masked”. The previous engine 2204.1 has a bug in Description. A space character is expected. Sorry for inconvenienc… --- ## [Invalid TSVAL value for PCLAS](https://forum.certara.com/t/invalid-tsval-value-for-pclas/1912)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [August 31, 2023, 8:36am UTC](https://forum.certara.com/t/invalid-tsval-value-for-pclas/1912 "2023-08-31T08:36:11Z")
Hi Hui, Yes, dataset should be populated with standard terms from a reference dictionary. Otherwise, those are not standard terms. Kind Regards, Sergiy --- ## [Pinnacle 21 Compatibility with Windows server 2022](https://forum.certara.com/t/pinnacle-21-compatibility-with-windows-server-2022/1959)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [August 10, 2023, 4:12pm UTC](https://forum.certara.com/t/pinnacle-21-compatibility-with-windows-server-2022/1959 "2023-08-10T16:12:09Z")
Hello Divya, Pinnacle 21 Community 4.0.2 is a desktop application designed for per-user installation on non-server Windows OS or Mac. It may still work fine if you don’t move any folders of the installation or your user… --- ## [Difference Between FDA 2204.0 and FDA Legacy 2010.1](https://forum.certara.com/t/difference-between-fda-2204-0-and-fda-legacy-2010-1/1824)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [June 1, 2022, 4:19pm UTC](https://forum.certara.com/t/difference-between-fda-2204-0-and-fda-legacy-2010-1/1824 "2022-06-01T16:19:45Z")
Hi Sahil, Please see a summary in CHANGELOG.txt file in …\\Documents\\Pinnacle 21 Community\\configs folder or access it by Help → Show Engine Changelog Kind Regards, Sergiy --- ## [P21 label does not match SDTM 3.2 IG](https://forum.certara.com/t/p21-label-does-not-match-sdtm-3-2-ig/1809)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [May 24, 2022, 3:15pm UTC](https://forum.certara.com/t/p21-label-does-not-match-sdtm-3-2-ig/1809 "2022-05-24T15:15:32Z")
Hi Lisa, Some variable labels in CDISC SDTM-IG documentation are not valid. For example, label for PPSTRESC is 43 characters long. It exceed limitation of 40 chars in SAS XPORT v5 format. You cannot implement it in your… --- ## [DART 1.1 and SEND 3.1.1 Rules](https://forum.certara.com/t/dart-1-1-and-send-3-1-1-rules/1786)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [February 28, 2022, 7:13pm UTC](https://forum.certara.com/t/dart-1-1-and-send-3-1-1-rules/1786 "2022-02-28T19:13:41Z")
Hi Jason, Support for DART, AR and SEND-IG 3.1.1 will be available soon in the next release of Community engine. Please note that your company already has it in Enterprise. Kind Regards, Sergiy --- ## [Define-XML v2 Stylesheet](https://forum.certara.com/t/define-xml-v2-stylesheet/1284)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 5\ **Last updated:** [May 26, 2021, 3:22pm UTC](https://forum.certara.com/t/define-xml-v2-stylesheet/1284 "2021-05-26T15:22:51Z")
Hi Lex, Thank you and all your team for developing this new stylesheet!!! We and some of our clients started using its draft version since September, 2018 even before its official release due to some new functionality.… --- ## [cross-check --OCCUR / --STAT](https://forum.certara.com/t/cross-check-occur-stat/1497)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [April 27, 2021, 1:55am UTC](https://forum.certara.com/t/cross-check-occur-stat/1497 "2021-04-27T01:55:36Z")
Hi Sandra, I think you refer to table “Situation/–PRESP/–OCCUR/–STAT” in section #4.5.7 of SDTM-IG 3.3. It looks like there are two potential new rules: Value for --OCCUR is populated, when --PRESP is NULL Value … --- ## [PINNACLE 21 Enterprise and Community difference for MEDDRA](https://forum.certara.com/t/pinnacle-21-enterprise-and-community-difference-for-meddra/1664)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [April 27, 2021, 1:37am UTC](https://forum.certara.com/t/pinnacle-21-enterprise-and-community-difference-for-meddra/1664 "2021-04-27T01:37:59Z")
Hi Junying, In Enterprise there is no need to select MedDRA version for validation. It’s already specified in your data package metadata. Kind Regards, Sergiy --- ## [How do Pinnacle 21 Enterprise generate define.xml verion2 and version1 validation report](https://forum.certara.com/t/how-do-pinnacle-21-enterprise-generate-define-xml-verion2-and-version1-validation-report/1663)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [March 9, 2021, 5:00pm UTC](https://forum.certara.com/t/how-do-pinnacle-21-enterprise-generate-define-xml-verion2-and-version1-validation-report/1663 "2021-03-09T17:00:53Z")
Hi Junying, Please note that this forum is design for support of Community users only. Please use Enterprise Support options instead. As a short summary to your question. I have no idea about your internal custom ut… --- ## [P21E study data packages removal](https://forum.certara.com/t/p21e-study-data-packages-removal/1659)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [March 9, 2021, 4:57pm UTC](https://forum.certara.com/t/p21e-study-data-packages-removal/1659 "2021-03-09T16:57:59Z")
Hi Junying, Please note that this forum is for support of Community. For questions about Enterprise, please contact Enterprise Support. For audit purposes, you cannot delete your work (CRF 21 Part 11 compliance). Howev… --- ## [Will Pinnacle 21 community add functionality to include data reviewer's guide, XLS stylesheet, SAP, tables (as reference files for define.xml ARM) in the validation package?](https://forum.certara.com/t/will-pinnacle-21-community-add-functionality-to-include-data-reviewers-guide-xls-stylesheet-sap-tables-as-reference-files-for-define-xml-arm-in-the-validation-package/1662)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [March 8, 2021, 8:03pm UTC](https://forum.certara.com/t/will-pinnacle-21-community-add-functionality-to-include-data-reviewers-guide-xls-stylesheet-sap-tables-as-reference-files-for-define-xml-arm-in-the-validation-package/1662 "2021-03-08T20:03:00Z")
Hi Junying, We do not have any particular plans at this moment. However, your company has already access to most of these features in Enterprise. Kind Regards, Sergiy --- ## [SDTM Validation Rule SD0065](https://forum.certara.com/t/sdtm-validation-rule-sd0065/1602)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [October 16, 2020, 12:04am UTC](https://forum.certara.com/t/sdtm-validation-rule-sd0065/1602 "2020-10-16T00:04:13Z")
Hi Marguerite, Yes, SD0065 rule algorithm includes an exception for EXOCCUR variable. In other domains --OCCUR variable exception doesn’t work. We will update Description to avoid confusions per your suggestion. Thank … --- ## [Technical rejection](https://forum.certara.com/t/technical-rejection/1535)
**Author:** [@jsk](https://forum.certara.com/u/jsk)\ **Replies:** 4\ **Last updated:** [June 23, 2020, 3:06pm UTC](https://forum.certara.com/t/technical-rejection/1535 "2020-06-23T15:06:52Z")
Hi Jan, I wonder why you ask this question here. The FDA guidelines are owned by the FDA, not by … If you navigate to Study Data Standards Resources | FDA and then to the bottom under “stay connected”, you will find a… --- ## [Versions of Validator Rules (FDA & CDISC) used in each Engine](https://forum.certara.com/t/versions-of-validator-rules-fda-cdisc-used-in-each-engine/1430)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [November 7, 2019, 4:24pm UTC](https://forum.certara.com/t/versions-of-validator-rules-fda-cdisc-used-in-each-engine/1430 "2019-11-07T16:24:15Z")
Hi Lisa, Thanks for your great suggestion! We has started thinking about its implementation. Kind Regards, Sergiy --- ## [About sheet "Validation Summary" of Pinnacle21 Validator Report](https://forum.certara.com/t/about-sheet-validation-summary-of-pinnacle21-validator-report/1425)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 1\ **Last updated:** [October 15, 2019, 4:07pm UTC](https://forum.certara.com/t/about-sheet-validation-summary-of-pinnacle21-validator-report/1425 "2019-10-15T16:07:00Z")
Hi Thanks for your post. There seems to be some confusion about how validation engines with Community 3.0.0 and higher. The validation engines version is the version of the executed validator and listed at the top of th… --- ## [Detailed CLI documentation for P21C v3.0](https://forum.certara.com/t/detailed-cli-documentation-for-p21c-v3-0/1399)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 0\ **Last updated:** [September 2, 2019, 1:16pm UTC](https://forum.certara.com/t/detailed-cli-documentation-for-p21c-v3-0/1399 "2019-09-02T13:16:06Z")
Dear all, In the blog “Introducing P21 Community 3.0” of May 8, 2019 it was mentioned that “an updated and more detailed CLI documentation will be published in the near future” (see attached screenshot). When will this… --- ## [MISTRESC Non-controlled Terminology](https://forum.certara.com/t/mistresc-non-controlled-terminology/1359)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [July 5, 2019, 9:18am UTC](https://forum.certara.com/t/mistresc-non-controlled-terminology/1359 "2019-07-05T09:18:17Z")
Hi Davina, According to SEND IG 3.1, MISTRESC variable is assigned to two different CT codelist. We are not sure about implementation of this business rule. Thank you, Sergiy --- ## [Pinnacle21 for 32 bits](https://forum.certara.com/t/pinnacle21-for-32-bits/1301)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [May 22, 2019, 6:24pm UTC](https://forum.certara.com/t/pinnacle21-for-32-bits/1301 "2019-05-22T18:24:50Z")
Hi Bérengére, Thanks for your suggestion! We are considering its implementation. Why do you need 32-bit version? We thought that nobody uses it anymore. Kind Regards, Sergiy --- ## [Pinnacle 21 Portable version](https://forum.certara.com/t/pinnacle-21-portable-version/1297)
**Author:** [@ufeddeka-4273](https://forum.certara.com/u/ufeddeka-4273)\ **Replies:** 1\ **Last updated:** [May 14, 2019, 10:17am UTC](https://forum.certara.com/t/pinnacle-21-portable-version/1297 "2019-05-14T10:17:05Z")
As the source code is released it is possible to compile portable or 32-bit version on your own. Dear Pinnacle 21 team, is it correct that any change to the source code (e.g., package.json) or compilation with different… --- ## [Pinnacle 21 3.0.0 My Documents folder](https://forum.certara.com/t/pinnacle-21-3-0-0-my-documents-folder/1295)
**Author:** [@gautotte](https://forum.certara.com/u/gautotte)\ **Replies:** 0\ **Last updated:** [May 10, 2019, 3:30pm UTC](https://forum.certara.com/t/pinnacle-21-3-0-0-my-documents-folder/1295 "2019-05-10T15:30:46Z")
Hello, I would like to know if, in future version, you could let the user select the location of the Pinnacle 21 Community 3.0.0 folder containing the configs/defines/logs/reports. Our IT department do not allow us to s… --- ## [flag non CDISC, non ADaMiG, non ADSL variables](https://forum.certara.com/t/flag-non-cdisc-non-adamig-non-adsl-variables/1270)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 2\ **Last updated:** [February 28, 2019, 6:15am UTC](https://forum.certara.com/t/flag-non-cdisc-non-adamig-non-adsl-variables/1270 "2019-02-28T06:15:31Z")
Hi Karl-Stephan, Thank you for this interesting suggestion! It could be added it as a new Notice rule like “Custom analysis variable”. Some people will appreciate it, other ones will hate it as extra validation issues … --- ## [FDAC0036 and FDA Study Technical Conformance Guide](https://forum.certara.com/t/fdac0036-and-fda-study-technical-conformance-guide/1241)
**Author:** [@jassigill05](https://forum.certara.com/u/jassigill05)\ **Replies:** 0\ **Last updated:** [October 5, 2018, 12:04pm UTC](https://forum.certara.com/t/fdac0036-and-fda-study-technical-conformance-guide/1241 "2018-10-05T12:04:53Z")
As per FDA study technical conformance guide: 3.3.3 Dataset Column Length The allotted length for each column containing character (text) data should be set to the maximum length of the variable used across all dataset… [Next page](https://forum.certara.com/c/pinnacle21/product-suggestions/8.md?page=1)