# SDTM **URL:** https://forum.certara.com/c/pinnacle21/support/sdtm/17.md [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) --- ## [About the SDTM category](https://forum.certara.com/t/about-the-sdtm-category/2127)
**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-sdtm-category/2127 "2025-03-24T02:26:19Z")
--- ## [LBSTREFC about SD1076, SD1078 rule IDs](https://forum.certara.com/t/lbstrefc-about-sd1076-sd1078-rule-ids/4425)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 2\ **Last updated:** [September 18, 2026, 12:12am UTC](https://forum.certara.com/t/lbstrefc-about-sd1076-sd1078-rule-ids/4425 "2026-09-18T00:12:31Z")
Hi All, In P21C PMDA (2411.1) & FDA (2508.1) SDTM IG V3.3 engines, though LBSTREFC is expected variable in SDTM IG V3.3, false positive findings occurred. Please fix it. Thank you. --- ## [Future Plans on Validation Rules related to DM.RACE/DM.ETHNIC](https://forum.certara.com/t/future-plans-on-validation-rules-related-to-dm-race-dm-ethnic/4394)
**Author:** [@harald.goldner](https://forum.certara.com/u/harald.goldner)\ **Replies:** 1\ **Last updated:** [May 13, 2026, 5:01pm UTC](https://forum.certara.com/t/future-plans-on-validation-rules-related-to-dm-race-dm-ethnic/4394 "2026-05-13T17:01:53Z")
Dear P21 Team, no urgent request, but I am curious if there are any plans to react to the following situation (in terms of validation rules), and if so, how: (1) FDA: Latest applicable and approved SDTM-IG is v3.4, req… --- ## [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… --- ## [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 --- ## [Many messages (false positives) "LBSTRESC value not found in 'Laboratory Test Standard Character Result' extensible codelist" for numeric values](https://forum.certara.com/t/many-messages-false-positives-lbstresc-value-not-found-in-laboratory-test-standard-character-result-extensible-codelist-for-numeric-values/2099)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 10\ **Last updated:** [March 13, 2025, 1:20pm UTC](https://forum.certara.com/t/many-messages-false-positives-lbstresc-value-not-found-in-laboratory-test-standard-character-result-extensible-codelist-for-numeric-values/2099 "2025-03-13T13:20:24Z")
Hi Jozef, What standard and version do you refer? Thank you, Sergiy --- ## [SDTM.TS](https://forum.certara.com/t/sdtm-ts/2068)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 9\ **Last updated:** [March 13, 2025, 5:25am UTC](https://forum.certara.com/t/sdtm-ts/2068 "2025-03-13T05:25:08Z")
Hi, Please see rules Description. In TS (Trial Summary) domain, populate a record TSPARMCD = ONGOSIND TSPARM = Ongoing Study Indicator TSVAL = Y or N depends of your study status Updated correct term for country cod… --- ## [NMPA recognization of NY variables and unplanned visits](https://forum.certara.com/t/nmpa-recognization-of-ny-variables-and-unplanned-visits/2110)
**Author:** [@yue.yang](https://forum.certara.com/u/yue.yang)\ **Replies:** 0\ **Last updated:** [March 13, 2025, 2:38am UTC](https://forum.certara.com/t/nmpa-recognization-of-ny-variables-and-unplanned-visits/2110 "2025-03-13T02:38:54Z")
Hi, When we’re using NMPA Engine, there are lots of issues related to NY value in Chinese in P21 report, such as SD1253 (DTHFL ≠ Y). This is because in datasets, we use 是 for Y and 否 for N. Can P21 add recognization f… --- ## [SDTM/dataset variable label mismatch](https://forum.certara.com/t/sdtm-dataset-variable-label-mismatch/2106)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 1\ **Last updated:** [March 7, 2025, 8:45pm UTC](https://forum.certara.com/t/sdtm-dataset-variable-label-mismatch/2106 "2025-03-07T20:45:04Z")
Hi Sahil, It’s still under discussion. P21 validation is often criticized to have extra rules. Community validation is limited to CDISC and regulatory agency submissions needs. Variable Label check is an example of rule… --- ## [STRESN value not matching STRESC value when the values are the same in XPT](https://forum.certara.com/t/stresn-value-not-matching-stresc-value-when-the-values-are-the-same-in-xpt/2071)
**Author:** [@mmangeshkar](https://forum.certara.com/u/mmangeshkar)\ **Replies:** 3\ **Last updated:** [December 27, 2024, 9:00am UTC](https://forum.certara.com/t/stresn-value-not-matching-stresc-value-when-the-values-are-the-same-in-xpt/2071 "2024-12-27T09:00:54Z")
Exactly why we should get rid of XPT as soon as possible. XPT is a completed outdated format, even discouraged by the US government (see SAS Transport File Format (XPORT) Family). In XPT, --STRESN values are stored in b… --- ## [Validation of CMDECOD values \>200 characters](https://forum.certara.com/t/validation-of-cmdecod-values-200-characters/2085)
**Author:** [@nancy.brucken\_1](https://forum.certara.com/u/nancy.brucken_1)\ **Replies:** 2\ **Last updated:** [December 26, 2024, 8:54pm UTC](https://forum.certara.com/t/validation-of-cmdecod-values-200-characters/2085 "2024-12-26T20:54:44Z")
Dear Nancy, I first was a bit confused about your statement about CMDECOD1, so I did some research. What currently (unfortunately) needs to be done is that the first 200 characters (or less, until the last semicolon in… --- ## [SDTM 3.2 IG PINNACLE MESSAGE](https://forum.certara.com/t/sdtm-3-2-ig-pinnacle-message/2087)
**Author:** [@radhika.patel](https://forum.certara.com/u/radhika.patel)\ **Replies:** 2\ **Last updated:** [December 26, 2024, 8:50pm UTC](https://forum.certara.com/t/sdtm-3-2-ig-pinnacle-message/2087 "2024-12-26T20:50:48Z")
SDTMIG-3.2 is based on SDTM model 1.4. So if VSORNRHI is not in the IG, you need to look into the corresponding model, which in your case is 1.4. For --ORNRHI in SDTM model 1.4, the label is “Normal Range Upper Limit-O… --- ## [Query Regarding Label Updates for COVAL and TSVAL Variables](https://forum.certara.com/t/query-regarding-label-updates-for-coval-and-tsval-variables/2081)
**Author:** [@yi.lu](https://forum.certara.com/u/yi.lu)\ **Replies:** 1\ **Last updated:** [December 3, 2024, 6:12pm UTC](https://forum.certara.com/t/query-regarding-label-updates-for-coval-and-tsval-variables/2081 "2024-12-03T18:12:24Z")
SD1130 is checking for a one-to-one relationship. Our SME team has reviewed this occurrence recently and it was determined that it wasn’t possible to update these rules to differentiate between multiple values for a pare… --- ## [SD1297 should not present for Trial Phase Response "NOT APPLICABLE"](https://forum.certara.com/t/sd1297-should-not-present-for-trial-phase-response-not-applicable/2051)
**Author:** [@ru.he](https://forum.certara.com/u/ru.he)\ **Replies:** 2\ **Last updated:** [October 30, 2024, 6:27pm UTC](https://forum.certara.com/t/sd1297-should-not-present-for-trial-phase-response-not-applicable/2051 "2024-10-30T18:27:16Z")
Could someone help with the question mentioned above? Thank you! --- ## [New born Child/Neonate Guidance Needed for SDTM Mapping](https://forum.certara.com/t/new-born-child-neonate-guidance-needed-for-sdtm-mapping/2061)
**Author:** [@venkat.parvataneni](https://forum.certara.com/u/venkat.parvataneni)\ **Replies:** 1\ **Last updated:** [September 20, 2024, 9:43am UTC](https://forum.certara.com/t/new-born-child-neonate-guidance-needed-for-sdtm-mapping/2061 "2024-09-20T09:43:30Z")
This is a forum about the use of P21 Community, not about SDTM mapping knowledge. The better choice is to use the LinkedIn “SDTM Experts” forum: LinkedIn Login, Sign in | LinkedIn which has over 3,300 particpants, incl… --- ## [Pinnacle21 CLI](https://forum.certara.com/t/pinnacle21-cli/2054)
**Author:** [@subins](https://forum.certara.com/u/subins)\ **Replies:** 1\ **Last updated:** [August 17, 2024, 8:45am UTC](https://forum.certara.com/t/pinnacle21-cli/2054 "2024-08-17T08:45:13Z")
A few questions back: What flavor of Java are you using? What version? Is it Oracle-Java, OpenJDK? The logs say something about JBoss … Is your system a Windows system, or Linux (Redhat?), what version? Regarding the … --- ## [SD9999 and Associated Persons (AP)](https://forum.certara.com/t/sd9999-and-associated-persons-ap/1261)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 8\ **Last updated:** [August 12, 2024, 1:45pm UTC](https://forum.certara.com/t/sd9999-and-associated-persons-ap/1261 "2024-08-12T13:45:55Z")
Hi, It’s correct. P21 Community 2.2.0 is quite outdated version. Please wait for the next release or consider Enterprise. Regards, Sergiy --- ## [SD2239 - Inconsistent value for -TPT](https://forum.certara.com/t/sd2239-inconsistent-value-for-tpt/2044)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 2\ **Last updated:** [July 18, 2024, 11:41am UTC](https://forum.certara.com/t/sd2239-inconsistent-value-for-tpt/2044 "2024-07-18T11:41:44Z")
Hi Brian, Our SME team is in the process of refining the rule so that SD2239 fires only if --DTC values contain both a date AND time, because if time is collected you should not have records for more than one time point… --- ## [Extent of Value Level Metadata](https://forum.certara.com/t/extent-of-value-level-metadata/1994)
**Author:** [@jessie.fritche](https://forum.certara.com/u/jessie.fritche)\ **Replies:** 7\ **Last updated:** [July 16, 2024, 2:30pm UTC](https://forum.certara.com/t/extent-of-value-level-metadata/1994 "2024-07-16T14:30:15Z")
To what extend you provide “ValueLevel” metadata in your define.xml is your choice. These are there to make the life easier for the reviewer in order to understand the submission. As already said in another post (Define… --- ## [DD0136 and DD0137 - Invalid dataset and variable label value](https://forum.certara.com/t/dd0136-and-dd0137-invalid-dataset-and-variable-label-value/2039)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [July 3, 2024, 8:07pm UTC](https://forum.certara.com/t/dd0136-and-dd0137-invalid-dataset-and-variable-label-value/2039 "2024-07-03T20:07:40Z")
Hello Soma, DD\* rules are define-specific rules so these two rules are only expected to fire against a define.xml. It sounds like you may be validated against SDTMIG 3.3 or greater. If so, some useful information can be… --- ## [NMPA report Rules sheet Severity column definition](https://forum.certara.com/t/nmpa-report-rules-sheet-severity-column-definition/1953)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 3\ **Last updated:** [June 26, 2024, 7:18pm UTC](https://forum.certara.com/t/nmpa-report-rules-sheet-severity-column-definition/1953 "2024-06-26T19:18:53Z")
Hi Panpan, P21 does not provide Severity from NMPA. Those are rather issue Type, rather than issue Severity. Common interpretation of Severity is potential impact to data quality in terms of processing or analysis. PMD… --- ## [Missing class identification- validating datasets](https://forum.certara.com/t/missing-class-identification-validating-datasets/2032)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 1\ **Last updated:** [June 24, 2024, 1:14pm UTC](https://forum.certara.com/t/missing-class-identification-validating-datasets/2032 "2024-06-24T13:14:31Z")
Hello Kavya, This is related to a known issue our team is aware of regarding populating Class in certain domains and Define-XML 2.1. The resolution of this will be delivered in a future engine release. Kind regards, M… --- ## [SD1124: missing value for xxREASND when xxSTAT is NOT DONE](https://forum.certara.com/t/sd1124-missing-value-for-xxreasnd-when-xxstat-is-not-done/534)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 6\ **Last updated:** [June 24, 2024, 9:04am UTC](https://forum.certara.com/t/sd1124-missing-value-for-xxreasnd-when-xxstat-is-not-done/534 "2024-06-24T09:04:22Z")
Hi Cathy, You are correct. --REASND is not conditionally required variable. I still think that a such check could be useful, but I am not sure about its best implementation. Could you confirm, that you populate --REAS… --- ## [Record Qualifiers Variable vs Timing Variable](https://forum.certara.com/t/record-qualifiers-variable-vs-timing-variable/2024)
**Author:** [@srpatel5](https://forum.certara.com/u/srpatel5)\ **Replies:** 1\ **Last updated:** [June 13, 2024, 5:23am UTC](https://forum.certara.com/t/record-qualifiers-variable-vs-timing-variable/2024 "2024-06-13T05:23:37Z")
Dear Sahil, I don’t think this is the right forum for this question: P21 did not develop SDTM nor was involved in it. As this is a question about “why this decision was made as it is when SDTM was originally developed”… --- ## [SD0063 is invalid in SDTM v3.3, but DD0137 is valid in Define-XML v2.1](https://forum.certara.com/t/sd0063-is-invalid-in-sdtm-v3-3-but-dd0137-is-valid-in-define-xml-v2-1/2023)
**Author:** [@john.chen](https://forum.certara.com/u/john.chen)\ **Replies:** 7\ **Last updated:** [June 13, 2024, 1:48am UTC](https://forum.certara.com/t/sd0063-is-invalid-in-sdtm-v3-3-but-dd0137-is-valid-in-define-xml-v2-1/2023 "2024-06-13T01:48:21Z")
The reason is simple … The rule that the variable label must be exactly as provided in the SDTMIG has been relaxed as of SDTMIG-3.3. It must however still correspond to what is present in the define.xml (2.x) under Ite… --- ## [TSVAL corresponding to EudraCT where TSPARMCD is REGID.](https://forum.certara.com/t/tsval-corresponding-to-eudract-where-tsparmcd-is-regid/2009)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 0\ **Last updated:** [May 21, 2024, 7:23am UTC](https://forum.certara.com/t/tsval-corresponding-to-eudract-where-tsparmcd-is-regid/2009 "2024-05-21T07:23:15Z")
Hi, I have a question about ‘REGID’ TSVCDREF. EudraCT number has been replaced by EU CT numbers since Feb 2023. But, “Values for TSVAL when TSPARMCD = “REGID” (Registry Identifier) will be identifiers assigned by the r… --- ## [Support validation SDTM IG 3.4](https://forum.certara.com/t/support-validation-sdtm-ig-3-4/1796)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 13\ **Last updated:** [May 16, 2024, 12:49pm UTC](https://forum.certara.com/t/support-validation-sdtm-ig-3-4/1796 "2024-05-16T12:49:51Z")
Hi, A scope for Community Validator is to support regulatory submissions. So far, none of regulatory agencies (FDA, PMDA, NMPA) accepts SDTMIG 3.4. Also, our industry metrics show that today most studies still utilize … --- ## [Cannot convert to LBSTRESU](https://forum.certara.com/t/cannot-convert-to-lbstresu/1676)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 4\ **Last updated:** [April 5, 2024, 1:55am UTC](https://forum.certara.com/t/cannot-convert-to-lbstresu/1676 "2024-04-05T01:55:34Z")
I presume this question is well beyond the scope of Pinnacle21 … “U/L” is an ARBITRARY unit, and its value (and thus also conversion factors for them) depends on the analyte that is measured. See e.g. Units per litre (U… --- ## [RFPENDTC](https://forum.certara.com/t/rfpendtc/2001)
**Author:** [@vikramkonakati](https://forum.certara.com/u/vikramkonakati)\ **Replies:** 2\ **Last updated:** [April 4, 2024, 2:06pm UTC](https://forum.certara.com/t/rfpendtc/2001 "2024-04-04T14:06:46Z")
Possible. But, please note if any of -DTC/-STDTC/-ENDTC dates across all domains are after RFPENDTC, validation warning may be occurred. [Next page](https://forum.certara.com/c/pinnacle21/support/sdtm/17.md?page=1)