Pinnacle 21 Community 2.2.0 Release Notes

Released 27-Sep-2016

Validator

• Changed default report name to start with pinnacle21 instead of opencdisc (enhancement)

Define.xml Generator

• Fixed CodeList assignments for variables in Define.xml v1.0 parsing (bug fix)
• Fixed Comment creation in Define.xml v1.0 parsing (bug fix)

ClinicalTrials.gov Miner

• Added tooltips that help in using the tool (enhancement)
• Added example query that can be run to show how the tool works (enhancement)
• Added example categories file that can be used along with the example query (enhancement)
• Fixed issue where only 'term=' or 'type=' could be used as a query (bug fix)

Rules

• SDTM
  • Added new configuration for SDTM Medical Devices 1.0 standard (enhancement)
  • Changed SD0005 and SD1117 rules to support Medical Devices standard (enhancement)
  • Removed rule SD1123 as it was a duplicate of SD0048 (enhancement)
  • Updated description for rule SD2208 to be consistent with other TS rules (enhancement)
  • Updated SD2240, SD2241, SD2242, SD2243, SD2245, and SD2256 rules not to fire when TSVALNF is populated (bug fix)
  • Corrected variable labels in SDTM 3.2 config for FALAT, TI.IETESTCD, and LBSTDY variables (bug fix)
  • Added missing variable definitions in SDTM 3.2 including SEEVINTX, SVDETECT, SVENINT, SVEVINTX, SVEVLINT, and SVSTINT (bug fix)
  • Added missing rule references in SDTM 3.2 mostly for new standard domains added since 3.1.3 (bug fix)
• SEND
  • Removed rule SD1123 as it was a duplicate of SD0048 (enhancement)
• Define.xml rules
  • Added rules DD0087 through DD0100 for Analysis Result Metadata (enhancement)
  • Disabled DD0042, DD0072, DD0073, and D00074 rules for Define.xml v1.0 (enhancement)
  • Changed DD0053 not to fire if the Standard Name can not be identified (enhancement)

Dictionaries

• Changed SDTM 2016-03-25 controlled terminology to 2016-03-27 (bug fix)
• Added 2016-09-08 release of NDF-RT (enhancement)
• Added 2016-08-08 and 2016-09-06 releases of UNII (enhancement)