Pinnacle 21 Community 2.1.2 Release Notes

Released 25-Jul-2016

Validator

  • Allow Literal value to be second argument of difference function (bug fix)
  • Avoid race conditions to avoid exception "The variable VARIABLE does not exist in this DataRecord" (bug fix)
  • Avoid specifying the same variable twice in global supplements (bug fix)
  • Improve delimited file parser performance of MedDRA files (enhancement)
  • Don't remove variables from supplemented record values since they can be useful (enhancement)

Define.xml Generator

  • Fixed excel export to use generated where clause id instead of parsed id (bug fix)
  • Fixed define validation failing on stylesheet element sharing a line with another element (bug fix)
  • Fixed define excel import upload hanging (bug fix)
  • Enhanced define validation performance (enhancement)

Data Converter

  • Fixed default selected tab of exported Excel file to be first tab (bug fix)

Rules

  • SDTM
    • Removed SD1076 and SD1078 rules from custom domains (bug fix)
    • Removed SD0063 and SD0063A rules from DA domain in SDTM 3.1.1 (bug fix)
    • Changed SD0064 rules to always treat USUBJID as text (bug fix)
    • Fixed SD2257-59 rules to correctly parse SNOMED files (bug fix)
    • Changed SD1201 rule message to be more generic (enhancement)
    • Changed SD1071 rule check for datasets larger than 5 GB per latest FDA guidance (enhancement)
  • SEND
    • Fixed order of variables in EX domain (bug fix)
    • Changed LBORNRLO and LBORNRHI to text (bug fix)
    • Changed SD1071 rule check for datasets larger than 5 GB per latest FDA guidance (enhancement)
  • Define.xml
    • Fixed DD0015 and DD0078 rules to prevent incorrect reporting of missing document references (bug fix)
    • Updated to latest CDISC XML Schema that supports Analysis Results Metadata (enhancement)
    • Added DD0000 notice to indicate that ARM was included in Define.xml (enhancement)

Dictionaries

  • Fixed incorrect codelist reference for TSVALCD where TSPARAMCD=RANDOM (bug fix)
  • Added automatic creation of MedDRA and SNOMED dictionary folders (enhancement)
  • Added 2016-06-26 releases of CDISC SDTM and SEND controlled terminologies (enhancement)
  • Added 2016-05-02, 2016-06-06, and 2016-07-05 releases of NDF-RT (enhancement)
  • Added 2016-05-20 and 2016-07-06 release of UNII (enhancement)

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