Pinnacle 21 Community 2.1.1 Release Notes

Released 25-Mar-2016

Validator

• Referencing a ValueList that doesn't exist causes the define.xml validator to crash (bug fix)
• Subject data supplements can cause exceptions when data lacks expected join column (bug fix)
• Validating data against define.xml that contains ValueList without a WhereClause causes exception during validation (bug fix)
• Validating data against define.xml with corrupt RangeCheck causes exception during validation (bug fix)
• Referencing a ValueList that doesn't exist causes the define.xml validator to crash (bug fix)
• Stop generating SKIP_* messages (enhancement)
• Regular expression rules should have When clause support (enhancement)

Define.xml Generator

• Removed invalid filename characters from studyname when generating excel or xml (bug fix)
• Variable Origin of "Predecessor" without translated text crashes system (bug fix)
• Value Level Variable Origin of "Predecessor" that has null element causes value level population to crash (bug fix)
• Create Spec failes when study name has slashes (bug fix)
• Some null attributes cause crashes during define.xml creation (bug fix)
• Do not create "Domain" attribute for ADaM studies (bug fix)
• Predecessor should not be included in non ADaM defines (bug fix)
• Update logic for deriving that a Dataset is split (bug fix)
• Remove invalid filename characters from studyname when generating excel or xml (bug fix)

Rules

• SDTM
  • Downgrade FINDINGS --STDTC to “Not Recommended" (bug fix)
  • QSMETHOD should be "Model Permissible" (bug fix)
  • SD1215, SD1217, and SD1219 rules cause validation to crash on 32-bit machines (bug fix)
  • DSENDTC should be “Prohibited" in all versions (bug fix)
  • Missing codelist for DSDECOD in configs (bug fix)
  • USUBJID on RELREC was incorrectly set to Required (bug fix)
  • Fixed incorrect variable labels in SDTM 3.1.2 (bug fix)
  • Added rule SD9999 to catch unrecognized datasets (enhancement)
• SEND
  • Downgrade FINDINGS --STDTC to “Not Recommended" (bug fix)
  • Change severity from "Notice" to "Warning" for FDAN031 and FDAN055 in SEND (FDA) config (bug fix)
  • Change SD0001 in SEND (FDA) config so that issues with TS, TX, DM are reported as "Error" (bug fix)
  • Change SD0002 in SEND (FDA) config so that issues with TS are reported as "Error" (bug fix)
  • Added rule SD9999 to catch unrecognized datasets (enhancement)
• ADaM
  • For all ADaM varables that end with "N" set Decoded Variable to its descriptive variable (bug fix)
  • Added rule AD9999 to catch unrecognized datasets (enhancement)
• Define.xml
  • Invalid integer data type issues are being incorrectly reported as DD0003 (bug fix)
  • DD0060 tries to match against the wrong instance of a variable (bug fix)
  • OD0021 should not fire when xml:lang is missing (bug fix
  • DD0010, DD0011, and DD0086 do not catch every case (bug fix)
  • DD0008, DD0009, and DD0086 rules should not be included in Define.xml (PMDA) config (bug fix)
  • DD0050 message is incorrect (bug fix)
  • Correct severities for PMDA Define.xml rules (bug fix)
  • Fix DD0049 and update description (bug fix)
  • Rule OD0012 generated false positives when define.xml had too many comments at the top of the file (bug fix)
  • Rule DD0082 did not take into account RoleCodelistOID when checking for unreferenced codelists (bug fix)
  • Rule DD0052 caused false positives when subfolder names were used in def:ArchiveLocationID leaf href (bug fix)
  • Rule DD0015 was only allowing variables to reference Annotated CRF (bug fix)
  • Rule DD0038 would fail if more than one ValueList was assigned to a SUPPQUAL dataset and one of the ValueLists didn’t have QVAL (bug fix)
  • Define validation for codelist-refs is incomplete (bug fix)

Dictionaries

• CDISC CT has incorrect Decode values for CL.TSVALNF (bug fix)
• Renamed CDISC CT codelists across all versions to be consistent with the latest version (bug fix)
• Added 2015-12-18 and 2016-03-25 releases of CDISC SDTM, ADaM, and SEND controlled terminologies (enhancement)
• Added 2016-01-04 and 2016-03-27 releases of NDF-RT (enhancement)
• Added 2016-01-24 release of UNII (enhancement)