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Releases

1.0.0.0

General

  • *NEW* GitHub integration now supported! This includes both public and private repositories as well as organisational projects.

  • *NEW* Introduction of credential manager to handle and securely store any Personal Access Tokens for external systems.

  • *NEW* Introduction of a SAS program template creation process.

  • Updated icons, labels, and headers throughout the ribbon.

  • Updated the icon images and text based on feedback.

  • "Dataset" section renamed to "Toggles".

Specifications

  • Export process is not a single click instead of two distinct processes.

Terminology

  • Faster lookups introduced for more efficiency processing.

Annotations

  • *NEW* Database annotations process introduced, quickly annotate the raw variables directly onto the case report form.

  • *NEW* Bookmarks process introduced, quickly add bookmarks to your case report form to aid in navigation.

  • Icons renamed:

    • "Tabulation" renamed to "SDTM Variables".

Packages

  • *NEW* Introduction of a percent complete process which links actual work vs. planned work to provide accurate estimates of percent complete.

  • Fixed on issue where SAS program author was being incorrectly assigned.

  • Improved the sponsor and study selection window to be easier and quicker.

  • Icons renamed:

    • "Report" renamed to "Status Report".

    • "Create" renamed to "Create Delivery".

Programming [*NEW*]

  • *NEW* Introduction a template creation process introduced, quickly generate your template SAS programs in seconds, including tabulation and analysis dataset programs and TFL output programs.

GitHub [*NEW*]

  • *NEW* GitHub authentication added to ensure private repositories are access securely.

  • *NEW* Introduction of a GitHub repository reports, quickly download a report from your chosen GitHub repository in seconds.

  • *NEW* Additionally introduction of a GitHub project reports, quickly download a report from your chosen GitHub Project in seconds.

CDISC CORE [Coming Soon]

  • *COMING SOON* With the imminent release of CDISC CORE, early testing is underway to bring this into the Metadata system.

0.2.0.0 [beta]

General

  • Updated icons, labels, and headers throughout the ribbon.

  • Updated the order of icons within the ribbon mirror the standard process of creation, order is now System, Options, Specifications, Terminology, Annotations, Packages.

  • Initial prompts for all processes removed.

  • Run times greatly improved.

Specifications

  • General:

    • Import Domain(s) button renamed to Create.

    • Ability to select the CDISC/NCI Controlled Terminology versions has been added to the CDISC prompt.

  • Tabulation:

    • When creating the specification using the SDTM IG version 3.4 the code list names will now appear, as previously the code list coded terms were appearing (i.e., C45677, etc.).

    • The format of the variable level metadata panel aligns with the define.xml version 2.1 with the multi-origin layout.

    • Progress bar added to indicate overall progress.

    • For subsequent runs any previously exported domains will be identified and removed from the available domains list.

    • NEW FEATURE Ability to export tabulation specifications to either a blank workbook or template workbook introduced.

    • NEW FEATURE The ability to quickly search for one or multiple domains has been added.

  • Analysis:

    • NEW FEATURE Introduction of the Analysis Specification Creation process.

Terminology

  • Code Lists Import renamed to Build.

  • Look-Up Code List renamed to Search.

  • All prompts have been updated to take up less space and the internal panels have been expanded to provide more room.

  • Code List details have been added to the Value List tables.

  • Several field labels have been updated to make it easier to understand.

  • Progress bar added to indicate overall progress.

  • Construction of any --TESTCD / --TEST & --PARMCD / --PARM code lists has been updated to ensure paired code lists are correctly constructed, i.e., the LBTESTCD values are displayed next to their LBTEST counterparts.

  • Search run times greatly improved.

  • NEW FEATURE Dual search introduced to ensure both the SDTM and ADAM code lists are read.

  • NEW FEATURE Introduced the ability to insert a blank row when the code list was not found within the CDISC documentation, specifically added for the analysis specifications.

  • NEW FEATURE Ability to export any code list to either a blank workbook, template workbook introduced or an existing and populated workbook introduced.

Annotations

  • Process redesigned with the introduction of three annotation types, domain level, variable level and full.

  • Annotations themselves updated to follow the CDISC Metadata Submission Guidelines, i.e., colours, font weight, etc.

  • Ability to include value level annotations added.

  • Orientation button removed and process updated to dynamically work out each page orientation.

Packaging [beta]

  • Introduction of a new packaging process which can create a deliverable package and or a study archive.

  • Introduction of a study report to be produced to return a realtime look at the study components and their metadata.

0.1.0.2 [beta]

Specifications

  • Implementation of the SDTM 3.4 implementation guide.

Terminology

  • Fixed a minor bug not allowing you to select ADaM then SDTM.

Annotations

  • Value level annotations feature added.

  • Interface changes including order of prompts changed.

  • Landscape button changed to Portrait, resulting in all CRF documents assumed to be in the landscape orientation by default.

0.1.0.1 [beta]

Specifications

  • Interface changed.

  • Copy to clipboard feature added.

  • Redundant buttons removed / greyed out.

Terminology

  • No change.

Annotations

  • No change.

0.1.0.0 [beta]

Specifications

  • When a single domain is selected the top table will transpose the row into two columns, mirroring the structure of the tabulation specification template.

  • Copy to clipboard button when a single domain will only copy the values required in the tabulation specification template.

  • Reference column added.

  • Reference predefined based on Domain and or Class value for all domains.

  • Repeating column added.

  • Repeating predefined based on Domain and or Class value for all domains.

  • Keys column added.

  • Keys predefined based on Class value for all domains.

  • Column ordering updated.

  • Removed the Export to CSV button.

  • During the domain select window, click a single cell will not highlight the entire row and not just the cell.

  • Removed the ability to sort by any of the column.

  • Remove the ability to resize the rows.

  • Domain column will not appear when a single domain is selected.

  • Rule values have been updated to be "Keep" instead of "KEEP".

  • Column ordering updated.

  • Role column removed.

  • Origin column added.

  • Origin values for common variables which are set to Keep by default added:

    • STUDYID = Protocol

    • DOMAIN = Assigned

    • USUBJID = Derived

    • --SEQ = Derived

    • VISITNUM = Derived

    • VISIT = Assigned

    • --DY = Derived

    • --STDY = Derived

    • --ENDY = Derived

    • EPOCH = Derived

    • --TEST = Assigned

    • --PARM = Assigned

    • --TPTNUM = Assigned

  • Copy to clipboard button will ignore Core and Order columns.

  • Copy to clipboard button will ignore Domain and not display the column when only a single domain was selected.

  • Copy to clipboard will insert an empty column between the Origin and Code List Code columns to mirror the tabulation specification template.

  • Code List column header updated to "Code List Code".

  • Removed the Export to CSV button.

  • Removed the ability to sort by any of the column.

  • Remove the ability to resize the rows.

Terminology

  • Fixed a bug when the user selects the type and version but then clicked cancel the process continued.

  • Look-Up Code List:

    • Look-up feature switched to modal; this will allow the user to still use EXCEL when the look-up dialogue window is open.

    • Look-up window made wider.

  • Import Code List(s):

    • Window updated to ensure when the user selects a single cell the entire row will be selected.

    • Export to CSV button removed.

    • Copy to clipboard button will ignore and not display Domain the column when only a single domain was selected.

    • Copy to clipboard will insert an empty column between the Value List Value and Value List Code columns to mirror the tabulation specification template.

    • Added to account for when code list values were not upper cased.

    • Process steps changed for single domains; process will now ask the user for the code list range before the domain prompt appears.

Annotations

  • Added the option for the process to include the domain label annotation when annotating single domains at a time.

  • Fixed a bug when the annotation was run a second time retaining the values from the previous run.

  • Disabled the Verify Columns button.

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