# ADaM **URL:** https://forum.certara.com/c/pinnacle21/support/adam/12.md [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) --- ## [About the ADaM category](https://forum.certara.com/t/about-the-adam-category/2122)
**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-adam-category/2122 "2025-03-24T02:26:19Z")
--- ## [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 … --- ## [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… --- ## [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… --- ## [AD0018: Variable label mismatch between dataset and ADaM standard (ASEQ)](https://forum.certara.com/t/ad0018-variable-label-mismatch-between-dataset-and-adam-standard-aseq/2082)
**Author:** [@peng.hu](https://forum.certara.com/u/peng.hu)\ **Replies:** 6\ **Last updated:** [March 5, 2025, 3:03pm UTC](https://forum.certara.com/t/ad0018-variable-label-mismatch-between-dataset-and-adam-standard-aseq/2082 "2025-03-05T15:03:58Z")
Hi Peng, Thanks for reaching out! This forum posts looks like it’s related to a data package in P21E so I will create an ESD ticket for this request. You will receive an email notification once this has been created. K… --- ## [Pinnacle 21 ADNCA support](https://forum.certara.com/t/pinnacle-21-adnca-support/2103)
**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\ **Replies:** 1\ **Last updated:** [February 27, 2025, 4:09pm UTC](https://forum.certara.com/t/pinnacle-21-adnca-support/2103 "2025-02-27T16:09:05Z")
Hi Nancy, P21C has support for ADNCA as recent as Engine 2304.3, but it’s limited to ADaMIG 1.3 only. P21E has support for ADNCA as recent as Engine 2304.0, and is also limited to ADaMIG 1.3 only. Right now, support i… --- ## [AD0047 --TERM for ADCM](https://forum.certara.com/t/ad0047-term-for-adcm/2004)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 4\ **Last updated:** [January 28, 2025, 3:39pm UTC](https://forum.certara.com/t/ad0047-term-for-adcm/2004 "2025-01-28T15:39:36Z")
Hello Lu, This is an issue that our team is aware of and is expected to be rectified in the next major engine release. Kind regards, Matt --- ## [AD0018: Variable label mismatch for SRCSEQ](https://forum.certara.com/t/ad0018-variable-label-mismatch-for-srcseq/2094)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 0\ **Last updated:** [January 15, 2025, 12:09pm UTC](https://forum.certara.com/t/ad0018-variable-label-mismatch-for-srcseq/2094 "2025-01-15T12:09:17Z")
Hello, I identified an issue with rule AD0018 - variable label mismatch for variable SRCSEQ. Per ADaM IG v1.2 the label of SCRSEQ is “Source Sequence Number” and I used this label but receive this warning. Is the check … --- ## [AD0018: Variable label mismatch, ATOXDSCH/L](https://forum.certara.com/t/ad0018-variable-label-mismatch-atoxdsch-l/2035)
**Author:** [@dana.delgo](https://forum.certara.com/u/dana.delgo)\ **Replies:** 3\ **Last updated:** [January 8, 2025, 3:10pm UTC](https://forum.certara.com/t/ad0018-variable-label-mismatch-atoxdsch-l/2035 "2025-01-08T15:10:39Z")
Dear all, we ran into the same issue. I would suppose that we have an issue with the ADAM 1.3 config XML, as the specs state: Analysis\*\* \*\*Toxicity\*\* \*\*Description High Analysis\*\* \*\*Toxicity\*\* \*\*Description High… --- ## [How to export ADaM package (zip)](https://forum.certara.com/t/how-to-export-adam-package-zip/2089)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [December 27, 2024, 3:19pm UTC](https://forum.certara.com/t/how-to-export-adam-package-zip/2089 "2024-12-27T15:19:42Z")
Hi Jane, For Enterprise questions please contact P21 Enterprise Support. We do not store ZIP file uploaded to Enterprise. After completion of the validation all study data are automatically deleted. Kind Regards, Ser… --- ## [ISS: multiple records in IADSL and IADAE](https://forum.certara.com/t/iss-multiple-records-in-iadsl-and-iadae/2072)
**Author:** [@mecn](https://forum.certara.com/u/mecn)\ **Replies:** 0\ **Last updated:** [October 14, 2024, 7:37pm UTC](https://forum.certara.com/t/iss-multiple-records-in-iadsl-and-iadae/2072 "2024-10-14T19:37:00Z")
We need to submit ISS for NDA. When we reviewed the ADaMs for ISS, we found out that IADSL has multiple record per subject and IADAE has multiple records for the same AE event on the same date for the subject. We have th… --- ## [AD0047 --SEQ false positive. Validation engine 2405.0](https://forum.certara.com/t/ad0047-seq-false-positive-validation-engine-2405-0/2060)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [September 20, 2024, 5:26am UTC](https://forum.certara.com/t/ad0047-seq-false-positive-validation-engine-2405-0/2060 "2024-09-20T05:26:38Z")
Hello Bartosz, This appears to be an Enterprise related question. I will create the appropriate ticket on your behalf and follow up there. Kind regards, Matt --- ## [AD0047 issue for ADMH using FDA 2304.3 Engine even though MHTERM exists in the dataset](https://forum.certara.com/t/ad0047-issue-for-admh-using-fda-2304-3-engine-even-though-mhterm-exists-in-the-dataset/2007)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [September 13, 2024, 2:36pm UTC](https://forum.certara.com/t/ad0047-issue-for-admh-using-fda-2304-3-engine-even-though-mhterm-exists-in-the-dataset/2007 "2024-09-13T14:36:38Z")
Hi Faith, There is a discussion around this topic in AD0047 --TERM for ADCM - ADaM - Certara where you can learn more. Kind regards, Matt --- ## [AD0018: Variable label mismatch between dataset and ADaM standard](https://forum.certara.com/t/ad0018-variable-label-mismatch-between-dataset-and-adam-standard/1865)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [August 13, 2024, 1:07pm UTC](https://forum.certara.com/t/ad0018-variable-label-mismatch-between-dataset-and-adam-standard/1865 "2024-08-13T13:07:31Z")
Hi Rajasekhar, According CDISC documentation, Labels for ASTDTM variable are “Analysis End Datetime” in BDS “Analysis End Date/Time” in OCCDS Kind Regards, Sergiy --- ## [AD0245 - CNSR is present, but STARTDT is not present](https://forum.certara.com/t/ad0245-cnsr-is-present-but-startdt-is-not-present/2050)
**Author:** [@system](https://forum.certara.com/u/system)\ **Replies:** 0\ **Last updated:** [August 12, 2024, 3:45pm UTC](https://forum.certara.com/t/ad0245-cnsr-is-present-but-startdt-is-not-present/2050 "2024-08-12T15:45:05Z")
In my TTE dataset, I have STARTDTM, but not STARTDT. ADaM IG 1.3 lists both STARTDT and STARTDTM as permissible, so it should be fine to have STARTDTM only, and not include STARTDT, but I am still receiving the message. … --- ## [Suggest: Label for acat01/02/04](https://forum.certara.com/t/suggest-label-for-acat01-02-04/2040)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [July 3, 2024, 8:08pm UTC](https://forum.certara.com/t/suggest-label-for-acat01-02-04/2040 "2024-07-03T20:08:42Z")
Hello Priyanka, This appears to be P21 Enterprise related so I will follow up with you via our Enterprise Support Desk. Kind regards, Matt --- ## [AD0196: Required AVALU value is null, ADNCA](https://forum.certara.com/t/ad0196-required-avalu-value-is-null-adnca/2036)
**Author:** [@dana.delgo](https://forum.certara.com/u/dana.delgo)\ **Replies:** 0\ **Last updated:** [June 25, 2024, 12:20pm UTC](https://forum.certara.com/t/ad0196-required-avalu-value-is-null-adnca/2036 "2024-06-25T12:20:53Z")
Hello, I get the following Error for the variable AVALU in ADNCA dataset: “AD0196: Required AVALU value is null”. The reason AVALU is null is because AVAL is missing. From the ADaMIG for Non-compartmental Analysis Inp… --- ## [SD1082 issue in ADaM validation using FDA 2304.3 Engine](https://forum.certara.com/t/sd1082-issue-in-adam-validation-using-fda-2304-3-engine/2034)
**Author:** [@bchan](https://forum.certara.com/u/bchan)\ **Replies:** 0\ **Last updated:** [June 21, 2024, 8:10pm UTC](https://forum.certara.com/t/sd1082-issue-in-adam-validation-using-fda-2304-3-engine/2034 "2024-06-21T20:10:44Z")
Since FDA 2304.3 engine was introduced last month, I have started getting a lot of SD1082 issue (Variable length is too long for actual data), while I did not get them with the previous engine (2204.1) when running ADaM … --- ## [AD0018 Error for ADNCA dataset](https://forum.certara.com/t/ad0018-error-for-adnca-dataset/2014)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [May 31, 2024, 8:24am UTC](https://forum.certara.com/t/ad0018-error-for-adnca-dataset/2014 "2024-05-31T08:24:18Z")
Hi Letizia, Thank you for including a screenshot of AD0018 firing. I confirmed with our team this is a known issue with these three labels and will be fixed in a future engine release. For now, the issue can be explaine… --- ## [AD0047 issue for ADEX using FDA 2304.3 Engine](https://forum.certara.com/t/ad0047-issue-for-adex-using-fda-2304-3-engine/2006)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [May 2, 2024, 6:52pm UTC](https://forum.certara.com/t/ad0047-issue-for-adex-using-fda-2304-3-engine/2006 "2024-05-02T18:52:58Z")
Hi Faith, Along with the discussion in AD0047 --TERM for ADCM - ADaM - Certara, can you also email the validation report to community@pinnacle21.com? Thank you, Matt --- ## [Validation for ADaM IG 1.3](https://forum.certara.com/t/validation-for-adam-ig-1-3/1997)
**Author:** [@johanna.voelkl](https://forum.certara.com/u/johanna.voelkl)\ **Replies:** 1\ **Last updated:** [March 5, 2024, 4:24pm UTC](https://forum.certara.com/t/validation-for-adam-ig-1-3/1997 "2024-03-05T16:24:18Z")
I am curious about this too. When can we expect this configuration to be usable in Pinnacle Community? --- ## [ADaM: SD1082: Variable length is too long for actual data](https://forum.certara.com/t/adam-sd1082-variable-length-is-too-long-for-actual-data/1939)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [January 24, 2024, 9:04pm UTC](https://forum.certara.com/t/adam-sd1082-variable-length-is-too-long-for-actual-data/1939 "2024-01-24T21:04:19Z")
Hi Daner, SD1082 rule algorithm is adjusted (2304.1 engine) to ignore any custom variables which are not defined in ADaM standard. In previous version any custom ADaM variables were considered as Char type, so SD1082 ru… --- ## [AD0018 - ADaM dataset variable label mismatch](https://forum.certara.com/t/ad0018-adam-dataset-variable-label-mismatch/494)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 13\ **Last updated:** [December 15, 2022, 11:37pm UTC](https://forum.certara.com/t/ad0018-adam-dataset-variable-label-mismatch/494 "2022-12-15T23:37:59Z")
Hi Vankata, Yes, it’s well known issue in v1.4. E.g., see http://www.opencdisc.org/forum/ad0018-variable-label-mismatch-validator-14 This bug was fixed in a new upcoming release of the validator. Thank you for your fi… --- ## [AD0256: USUBJID value does not exist in the ADaM ADSL domain](https://forum.certara.com/t/ad0256-usubjid-value-does-not-exist-in-the-adam-adsl-domain/1893)
**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\ **Replies:** 1\ **Last updated:** [December 5, 2022, 10:09pm UTC](https://forum.certara.com/t/ad0256-usubjid-value-does-not-exist-in-the-adam-adsl-domain/1893 "2022-12-05T22:09:49Z")
Hi, You are correct that this rule searches by STUDYID, USUBJID to find matches. We don’t plan to update the rule to remove STUDYID at this time as we are waiting for CDISC to publish formal checks for integrated studie… --- ## [AD1012A Secondary variable is present but its primary variable is not present Fires for ABLF](https://forum.certara.com/t/ad1012a-secondary-variable-is-present-but-its-primary-variable-is-not-present-fires-for-ablf/1691)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [October 15, 2022, 10:52am UTC](https://forum.certara.com/t/ad1012a-secondary-variable-is-present-but-its-primary-variable-is-not-present-fires-for-ablf/1691 "2022-10-15T10:52:10Z")
Hi Melissa, What validation engine do you use? AD1012A rule is under continuous adjustment. Thank you, Sergiy --- ## [AD0221 CHGCAT1 value inconsistent](https://forum.certara.com/t/ad0221-chgcat1-value-inconsistent/1873)
**Author:** [@raja777pharma\_1](https://forum.certara.com/u/raja777pharma_1)\ **Replies:** 0\ **Last updated:** [October 11, 2022, 5:22am UTC](https://forum.certara.com/t/ad0221-chgcat1-value-inconsistent/1873 "2022-10-11T05:22:56Z")
Hi Team, I am getting AD0221 error for CHGCAT1 as value inconsistent with CHG values. getting error for record Record PARAMCD CHG CHGCAT1 169787 LGHBSAG -1.47182854 Increase Please confirm is P21 rounding the value … --- ## [AD0018 Analysis Flag Variable label mismatch](https://forum.certara.com/t/ad0018-analysis-flag-variable-label-mismatch/1869)
**Author:** [@raja777pharma\_1](https://forum.certara.com/u/raja777pharma_1)\ **Replies:** 0\ **Last updated:** [September 22, 2022, 10:07am UTC](https://forum.certara.com/t/ad0018-analysis-flag-variable-label-mismatch/1869 "2022-09-22T10:07:57Z")
Hi Team, I am using the P21 community version P2120210.1 and ADaM IG 1.1 I am getting AD0018 error for the below variable labels. CQ99NAM = Customized Query 99 Name - COVID 19 AE ANL99FL = Analysis Flag 99 - Med use … --- ## [How to map Associated person's data from SDTM to ADaM datasets/](https://forum.certara.com/t/how-to-map-associated-persons-data-from-sdtm-to-adam-datasets/1452)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 4\ **Last updated:** [September 16, 2022, 5:08am UTC](https://forum.certara.com/t/how-to-map-associated-persons-data-from-sdtm-to-adam-datasets/1452 "2022-09-16T05:08:47Z")
Hi Pryanka, You can not have the same USUBJID for different persons even for those who are mothers and their babies. I am not aware about ADaM guidance for AP data and ADaM validation rules from CDISC team. ADSL means… --- ## [AD0221 fires for ACAT1 variable](https://forum.certara.com/t/ad0221-fires-for-acat1-variable/1862)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [August 25, 2022, 2:00pm UTC](https://forum.certara.com/t/ad0221-fires-for-acat1-variable/1862 "2022-08-25T14:00:13Z")
Hi Rob, My suggestion is to follow ADaM-IG and use different names for your variables which look have different meaning than ADaM \*CATy variables. Kind Regards, Sergiy --- ## [Rule AD0196 Required ARM value is null](https://forum.certara.com/t/rule-ad0196-required-arm-value-is-null/1642)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 5\ **Last updated:** [August 18, 2022, 12:54pm UTC](https://forum.certara.com/t/rule-ad0196-required-arm-value-is-null/1642 "2022-08-18T12:54:20Z")
Hi Jennifer, Thank you for bringing attention to this issue! Formally, current algorithm of AD0196 rule should be adjusted for FDA case as you suggested. Before doing this we need to confirm that FDA Reviewers will be … [Next page](https://forum.certara.com/c/pinnacle21/support/adam/12.md?page=1)