# Pinnacle 21 **URL:** https://forum.certara.com/c/pinnacle21/6.md?page=1 [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) **Page:** 2 --- ## [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… --- ## [Analysis Results Metadata Multiple Parameters](https://forum.certara.com/t/analysis-results-metadata-multiple-parameters/4365)
**Author:** [@Kate1](https://forum.certara.com/u/Kate1)\ **Replies:** 0\ **Last updated:** [February 16, 2026, 2:28pm UTC](https://forum.certara.com/t/analysis-results-metadata-multiple-parameters/4365 "2026-02-16T14:28:04Z")
Hi all, I suspect this may have been raised before, apologies, but I wanted to check how the ParameterOID should be handled within the ARM for ADaM defines when multiple ADaMs are used in an analysis output. For example… --- ## [Pinnacle 21 Community has expired due to an extended period with no internet connection](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet-connection/1894)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 15\ **Last updated:** [February 13, 2026, 2:38pm UTC](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet-connection/1894 "2026-02-13T14:38:47Z")
Hi Leonid, You can re-install P21 Community. Kind Regards, Sergiy --- ## [DS中有知情同意的记录，但P21却报了 Message：DS域内没有取得受试者知情同意的记录?](https://forum.certara.com/t/ds-p21-message-ds/1729)
**Author:** [@fen.zhang](https://forum.certara.com/u/fen.zhang)\ **Replies:** 3\ **Last updated:** [February 11, 2026, 3:07am UTC](https://forum.certara.com/t/ds-p21-message-ds/1729 "2026-02-11T03:07:30Z")
Bonnie： 你好！感谢您向我们反馈这个bug。 这是由于Rule SD1240在中文环境下出错所致。我们会立即修复。 再次感谢！ PJ --- ## [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… --- ## [ASSIGNING NATURAL KEY variables from SUPPQUAL](https://forum.certara.com/t/assigning-natural-key-variables-from-suppqual/1175)
**Author:** [@sara\_ks](https://forum.certara.com/u/sara_ks)\ **Replies:** 4\ **Last updated:** [January 26, 2026, 4:54pm UTC](https://forum.certara.com/t/assigning-natural-key-variables-from-suppqual/1175 "2026-01-26T16:54:30Z")
I don’t think there is a well-defined mechanism for this. The natural keys are assigned at the ItemGroupDef/ItemRef level, and the supplemental qualifier variables do not appear there. The reason is that SDTM and the F… --- ## [ADaM PCSTRESU CT](https://forum.certara.com/t/adam-pcstresu-ct/4352)
**Author:** [@k-saku](https://forum.certara.com/u/k-saku)\ **Replies:** 4\ **Last updated:** [January 8, 2026, 7:04am UTC](https://forum.certara.com/t/adam-pcstresu-ct/4352 "2026-01-08T07:04:03Z")
ADPCにPCSTRESUを実装していますが、ADaMのdefineのバリデーションで、DD0118およびDD0028のIssueが表示されます。SDTM IG3.3に準拠して作成しているため、PCSTRESUのCTはPK UNITを定義しておりますが、それが原因でしょうか。Issueの解消方法などありますでしょうか。 --- ## [P21E v6.1.0 -\> SD1230: Value level datatype must match the datatype described in define.xml.](https://forum.certara.com/t/p21e-v6-1-0-sd1230-value-level-datatype-must-match-the-datatype-described-in-define-xml/2075)
**Author:** [@denys.hryhorenko](https://forum.certara.com/u/denys.hryhorenko)\ **Replies:** 2\ **Last updated:** [December 26, 2025, 3:13am UTC](https://forum.certara.com/t/p21e-v6-1-0-sd1230-value-level-datatype-must-match-the-datatype-described-in-define-xml/2075 "2025-12-26T03:13:15Z")
Hi Denys, This post seems to be related to a data package in P21E so I will create a ticket in ESD to investigate this and provide more information. You will receive an email notification once this has been created. Ki… --- ## [Pushing dictionaries to all users](https://forum.certara.com/t/pushing-dictionaries-to-all-users/4348)
**Author:** [@Awais\_Tahir\_Contract](https://forum.certara.com/u/Awais_Tahir_Contract)\ **Replies:** 2\ **Last updated:** [November 18, 2025, 11:22pm UTC](https://forum.certara.com/t/pushing-dictionaries-to-all-users/4348 "2025-11-18T23:22:49Z")
Hi Pinnacle 21 C Team. Can you please tell me the steps how we can make sure all users within the company are using same version of dictionaries? For example MedDRA, Is there a way to centrally install or make these dic… --- ## [AD0200: ADaM/dataset variable type mismatch](https://forum.certara.com/t/ad0200-adam-dataset-variable-type-mismatch/4346)
**Author:** [@Tibi](https://forum.certara.com/u/Tibi)\ **Replies:** 3\ **Last updated:** [November 17, 2025, 4:48pm UTC](https://forum.certara.com/t/ad0200-adam-dataset-variable-type-mismatch/4346 "2025-11-17T16:48:41Z")
Hi everyone, I am getting the following error “AD0200: ADaM/dataset variable type mismatch” for all ADaM datasets when using latest P21E engine and ADaM IG 1.3. These errors were not present in earlier validations and … --- ## [SD2244 (Invalid TSVCDREF value for FCNTRY)について](https://forum.certara.com/t/sd2244-invalid-tsvcdref-value-for-fcntry/4344)
**Author:** [@seiko.yamazaki](https://forum.certara.com/u/seiko.yamazaki)\ **Replies:** 0\ **Last updated:** [November 5, 2025, 6:10am UTC](https://forum.certara.com/t/sd2244-invalid-tsvcdref-value-for-fcntry/4344 "2025-11-05T06:10:26Z")
SD2244に関して、PMDA 2411.0においてTSVCDREFの値を「ISO 3166」ではなく「ISO 3166-1 alpha-3」に変更しました。ただし、CDISC Conformanceルールでは、この変更はSDTM IG v3.2およびv3.3にのみ適用され、v3.4には適用されません。DICTNAMコードリストが代わりにTSVCDREFに適用されます。SDTM IG v3.4でTSVCDREF=”ISO 3166-1 … --- ## [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… --- ## [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, --- ## [SD1339: Missing EPOCH value when a start or observation date is provided](https://forum.certara.com/t/sd1339-missing-epoch-value-when-a-start-or-observation-date-is-provided/4282)
**Author:** [@Pavan\_K](https://forum.certara.com/u/Pavan_K)\ **Replies:** 4\ **Last updated:** [October 6, 2025, 6:29pm UTC](https://forum.certara.com/t/sd1339-missing-epoch-value-when-a-start-or-observation-date-is-provided/4282 "2025-10-06T18:29:24Z")
We have some historical records in finding domains as they collected for historical comparison before trial start like weight of the subject. These assessments have the DTC before the informed consent date. How to popul… --- ## [Pinnacle21 check ADaM vs. SDTM](https://forum.certara.com/t/pinnacle21-check-adam-vs-sdtm/1283)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 8\ **Last updated:** [September 4, 2025, 12:17am UTC](https://forum.certara.com/t/pinnacle21-check-adam-vs-sdtm/1283 "2025-09-04T00:17:25Z")
Hi Manolya, Yes, P21 validation for ADaM IG 1.1 includes traceability rules similar to ADaM IG 1.0. The execution of these rule requires adding AE, DM and EX datasets when validating ADaM data. This is very important e… --- ## [P21C - Define Error occurring with Custom Columns](https://forum.certara.com/t/p21c-define-error-occurring-with-custom-columns/4313)
**Author:** [@Samantha\_Brown](https://forum.certara.com/u/Samantha_Brown)\ **Replies:** 1\ **Last updated:** [August 5, 2025, 2:24pm UTC](https://forum.certara.com/t/p21c-define-error-occurring-with-custom-columns/4313 "2025-08-05T14:24:22Z")
Some background - Utilizing the P21’s ADaM specification template, I have added custom columns in the right-most area of both the Variable and ValueLevel tabs. These columns house excel formulas to help ensure Methods m… --- ## [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… --- ## [About SD1448 Rule](https://forum.certara.com/t/about-sd1448-rule/4266)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 1\ **Last updated:** [June 26, 2025, 7:43pm UTC](https://forum.certara.com/t/about-sd1448-rule/4266 "2025-06-26T19:43:45Z")
Hi All, This is Minji. I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2. Rule ID SD1448 validation result was generated when LBSTRESC was “142.”. However, I think that SD1448… --- ## [Pinnacle 21 Community has expired due to an extended period with no internet](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet/4265)
**Author:** [@Kristina\_Levi](https://forum.certara.com/u/Kristina_Levi)\ **Replies:** 0\ **Last updated:** [June 19, 2025, 1:03pm UTC](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet/4265 "2025-06-19T13:03:57Z")
Hello, Pinnacle21 Community 4.1.0 fails to run from the command line giving the following message in the log: CLI.3.17::Pinnacle 21 Community has expired due to an extended period with no internet connection. Connect t… --- ## [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… --- ## [Pinnacle21 4.1 Offline Use Recommendations](https://forum.certara.com/t/pinnacle21-4-1-offline-use-recommendations/4258)
**Author:** [@Zach\_Rooney](https://forum.certara.com/u/Zach_Rooney)\ **Replies:** 2\ **Last updated:** [June 16, 2025, 3:59pm UTC](https://forum.certara.com/t/pinnacle21-4-1-offline-use-recommendations/4258 "2025-06-16T15:59:08Z")
Hello, What are your recommendations for running Pinnacle 21 C in a secure environment? We have been using P21 C in a secure environment and manually installing the newest version every 6 months. The latest installer, … --- ## [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: … --- ## [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? --- ## [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… --- ## [Please adjust QSMETHOD CT2002 validation rule](https://forum.certara.com/t/please-adjust-qsmethod-ct2002-validation-rule/4225)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 2\ **Last updated:** [June 5, 2025, 12:09am UTC](https://forum.certara.com/t/please-adjust-qsmethod-ct2002-validation-rule/4225 "2025-06-05T00:09:59Z")
Hi All, This is Minji. I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2. A Rule ID CT2002 validation was run under Method CT for the QSMETHOD variable. It looks like QRSMTHOD… --- ## [Question: Can I include a codelist in Define.xml for an empty variable that wasn’t collected in the CRF?](https://forum.certara.com/t/question-can-i-include-a-codelist-in-define-xml-for-an-empty-variable-that-wasn-t-collected-in-the-crf/4226)
**Author:** [@a.shtaiwi](https://forum.certara.com/u/a.shtaiwi)\ **Replies:** 1\ **Last updated:** [June 3, 2025, 8:05pm UTC](https://forum.certara.com/t/question-can-i-include-a-codelist-in-define-xml-for-an-empty-variable-that-wasn-t-collected-in-the-crf/4226 "2025-06-03T20:05:51Z")
Hi everyone, I have a quick question I hope someone can help me about it! In my SDTM dataset, I have a variable (e.g., QEVAL) that: Is included in the dataset structure (it appears as a column), Has all null values (… --- ## [SD1066 Null IDVARVAL when RELYTPE populated](https://forum.certara.com/t/sd1066-null-idvarval-when-relytpe-populated/4218)
**Author:** [@Kylar\_Mikkelson](https://forum.certara.com/u/Kylar_Mikkelson)\ **Replies:** 1\ **Last updated:** [May 20, 2025, 9:12pm UTC](https://forum.certara.com/t/sd1066-null-idvarval-when-relytpe-populated/4218 "2025-05-20T21:12:46Z")
Hi Pinnacle Team, I was hoping for clarification about SDTM validation rule SD1066, which implies IDVARVAL must be null when RELTYPE is populated in RELREC. While I understand this is the most common way of relating dat… --- ## [SD1151 / FDAB009](https://forum.certara.com/t/sd1151-fdab009/1906)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 5\ **Last updated:** [May 19, 2025, 2:45pm UTC](https://forum.certara.com/t/sd1151-fdab009/1906 "2025-05-19T14:45:20Z")
Hi Elizabeth, SD1150 and SD1151 rules will be updated in the next Engine release by adding TIVERS variable as shown in your example. Kind Regards, Sergiy --- ## [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… --- ## [Error while running ADaM package using PMDA engine](https://forum.certara.com/t/error-while-running-adam-package-using-pmda-engine/4193)
**Author:** [@anantha.khandavilli](https://forum.certara.com/u/anantha.khandavilli)\ **Replies:** 4\ **Last updated:** [April 30, 2025, 5:04pm UTC](https://forum.certara.com/t/error-while-running-adam-package-using-pmda-engine/4193 "2025-04-30T17:04:29Z")
Hi Team, We are trying to validate ADaM package using PMDA engine but are running into errors. Error Message: “Validation failed. Please check that your upload has corrupted data with a valid file type.”. Engine: PMDA… [Previous page](https://forum.certara.com/c/pinnacle21/6.md) [Next page](https://forum.certara.com/c/pinnacle21/6.md?page=2)