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SEND Explorer® Express

The SEND Explorer Product Family v4.1 is a web-based system developed to provide advanced viewing, data analysis and visualization capabilities for study data produced in SEND (Standard for Exchange of Nonclinical Data) format. The SEND data standard is a requirement for NDA and IND submissions to US Food and Drug Administration (FDA) containing in-scope study data for studies starting in late 2016 and beyond. SEND is also used as a data exchange standard between CROs (contract research organizations) and sponsor companies. The standard file format for SEND is SAS transport (XPT), but the structure and format of the data make it difficult to view and understand using standard desktop tools.

SEND Explorer Express v4.1 is a no-charge tool that allows users to upload their SEND SAS transport files in .zip format, using a standard web browser (Internet Explorer, Google Chrome, Firefox) and merges study and subject metadata with findings data to make it easier to review, QC, and query your SEND data.

Limitations

SEND Explorer Express is provided at no charge to individuals and organizations and no warranty is stated or implied. Anyone who chooses to use SEND Explorer Express is expected to perform testing to confirm that the application functions as intended. The SEND Explorer Product Family, including SEND Explorer Express, requires a modern browser, such as Internet Explorer 10+, Chrome or Firefox. Browser qualification testing should be performed to ensure that intended functionality is supported by the browser you use. SEND Explorer Express does not permit export of data to CSV, group summarizations, or visualizations for user-supplied data; however, all of these features are fully-functional for the sample datasets provided. SEND Explorer Express does not support Subject View (even for the sample datasets). SEND Explorer Express is not a validator - datasets should go through a SEND data validator and errors resolved and warnings examined prior to loading data in SEND Explorer Express.

Format Requirements

The current release of SEND Explorer Plus supports SEND v3.0. SAS XPT files for studies in SEND 3.0 format must be saved to a .zip file and then the .zip files can be uploaded using SEND Explorer Express directly into the single study viewer from a local or network location for temporary use.

Single-Study Functionality

Click on the Upload SEND File button from the top button bar. To load a local SEND .zip file up for viewing, click "Browse" to locate the .zip file, then click "Upload". You can also select one of two previously-loaded sample datasets to the SEND Explorer database from the pulldown menu.

Domain Selection

Available data displays by domain in a pull-down list, including the two-character domain abbreviation the domain decode and the record count for each domain. If there is a problem loading any domain, it will appear in the pull-down list with a 0 record count. Click the domain of interest to populate the grid with the data from that domain. Domains with a large number of rows will take longer to display - the "Loading..." message displays to confirm that progress is occurring.

Data Grid

Domain-specific data appear in a grid display. For findings domains, the results data will be merged with the associated subject and group metadata, with metadata columns appearing first in the grid. The color of the headers for the metadata columns will be differentiated using a slightly darker shade of grey. Any columns that are blank for the entire domain will be suppressed by default, but can be displayed using the "Select Columns" option. Use the "Select Columns" option to hide or show any column of interest. Drag and drop columns on the "Select Columns" pop-up to reorder columns in the grid. Grids for all domains have similar functionality including page navigation, column management, sorting, filtering, and ability to export grid contents to CSV for use in Excel.

Page Navigation

Up to thirty rows will appear on each page; use the single arrows to navigate from page to page or the double arrows to go immediately to the first or last page. You can also use keyboard navigation: J (one page backward), K (one page forward), L (last page), and I (first page). The width of each column displaying on a page will adjust to accommodate the largest width of the data on that page. Some fields (e.g., EXTRT) display a fixed maximum width and include ellipses to indicate that the actual content is longer than the width of the column. Mouse-over the cell to reveal the full text.

Column Headers

Column headers are populated with SEND short field names. Long field name labels are displayed as a mouse-over on each column label. A full definition from the SEND Implementation Guide can be displayed for each column header by holding down the Control key and selecting the column header text. Column header long names and definitions are not available for pivoted columns. The column header appears in italicized grey font if ALL of the values for that column are identical (e.g., the Domain or Study ID fields). Since these fields are non-differentiating across all the rows in the domain, these columns are good candidates to remove from the display.

Column Management

By default, all columns that include data for a domain are displayed in the grid. Columns with no data are hidden by default from the display. A column can be removed from the grid by hovering over the bottom left of the column label and clicking on the scissors icon that appears. Additional columns can be added to the display and columns can be reordered by selecting "Select Columns." Click the checkbox next to any column to add that column to the grid or click "Show All Columns" to add all columns to the grid. Click "Hide Empty Columns" to remove empty columns from the grid. Columns can be reordered in the grid by dragging and dropping them in the Select Columns dialog windows.

Sorting

A domain-specific default sort order is applied upon initial access to a domain. Click on any column header to sort the entire domain by ascending column values; click again to sort them in descending order. An up/down triangle will display in the column header to remind you which field is being used for the sort. Click the up/down triangle to restore the default sort order. Use the "Reset" button to remove all column customizations, sorting, or filtering; i.e., effectively the same as re-opening the current domain.

Filtering

A black filter icon appears in the second row of each column header. Click the icon (or anywhere in the row) to select specific values of interest. Use "(Select All)" to simultaneously toggle all selections either on or off. Once you have made filtering selections in a column, the filter icon changes from black to white to help identify which fields were used for filtering. Contents of the filtering pull-downs are data-driven: once any filtering is applied, the contents of the filtering selections on all remaining fields are modified to display only those values that are still valid after the previous filtering has been applied. The user can alternatively apply operator-based filtering for any field. The available operators (e.g., =, >, <, contains, begins with) will depend on whether the field is a numeric field, a character field, or a date field. If all remaining values for any column are identical after the filtering is applied, the column header will display in italicized grey font to indicate that the content of the column after filtering has become non-differentiating.

Pivot

For findings domains, the initial grid parallels the layout of the SEND file: one row per subject per endpoint per timepoint. Pivot functionality allows the user to switch to multiple timepoints, endpoints, or subjects per row. For example, Pivot by Timepoint formats the data to a single row per subject per endpoint, with distinct timepoints displayed as separate columns. The user can specify whether the pivoted values should be the original results or the standardized results. Sorting, filtering, and column show/hide functionality also works with pivoted data. Some pivoted columns may contain both numeric and character data (e.g., LB columns containing pivoted standardized results by timepoint); filtering on these pivoted columns assumes numeric filtering, but the user can toggle between numeric and character-based string filtering using the A/# toggle.

Summary

For SEND Explorer Express, summary functionality is only available for the sample datasets. The Summary View includes group summary measures (n, mean, standard deviation). Click the + sign next to any group header or Open/Collapse all groups to additionally display individual subject data for numeric findings domains. Rows which contain group or summary measures are shaded; rows with individual subject findings are unshaded. The user can specify which field(s) define the group: Sex, Dose, Disposition Event, Sponsor Group Code, Planned Arm Code, and/or Set Code. The summary display automatically applies an appropriate pivot, and summary measures are only produced for numeric measures. If one or more subjects in a group have a non-numeric value for a numeric endpoint, an "@" appears next to the Mean label.

Thumbnail visualizations appear at the top of each page in the summary view to provide a graphical depiction of the subject and/or summary measures for each endpoint. Any of three different graphs can be selected by clicking in the cell directly below the Row Type column header: zero-based scatter plot, range-based scatter plot, or bar graph of group means. Both zero-based and range-based scatter plots depict the group means (shown as horizontal black lines) and individual values (shown as circles) with each group showing in a different color. The scatter plots allow the user to visualize the spread of the data points within a group and across groups. The same axis is used for all occurrences of a given endpoint for both sexes and across all timepoints, making side-by-side comparison of the plots meaningful. The difference between the two plots is that the y-axis scaling for the "Scatter Plot - zero" visualization is 0 to max value observed for that endpoint across all timepoints and both sexes, while the y-axis scaling for "Scatter Plot - range" covers min value observed to max value observed and the y-axis scaling for "Bar Graph - Means" is 0 to max mean value. Mouse-over the individual values to see the actual value and corresponding subject ID. Click on any thumbnail visualization to produce a larger version (with title and labeled axes) that can be copied to clipboard and pasted into another application (e.g., Word, PPT).

Click the up/down arrow icon in the top row of the summary view to display reference range highlighting, which uses color coding to identify the minimum and maximum values observed in individual subjects in the control (reference) group and to flag values (via colored arrows) for individual subjects in treated groups that are greater or less than the range observed in the concurrent controls at the same timepoint. The colored arrows facilitate identification of values that are outside the range of values seen in the corresponding control group. . If the group mean value for any treated group falls outside the range of values observed in the control (reference) group, an up/down arrow will display next to the group mean. In addition, for groups other than the control (reference) group, a new row is included in the summary section for each group which displays the calculated percent change between the treated group mean and the corresponding reference group mean.

For non-numeric findings domains (excluding Clinical Observations (CL) and Palpable Masses (PM)), data in the summary view are displayed as individual findings with group summary incidence counts in a Severity Heat Map visualization. Findings are color-coded from yellow to orange to red depending on the severity of the finding. Severity Heat Maps provide color-coding by severity for macroscopic (MA domain) and microscopic (MI domain) findings or by malignancy status for tumor findings (TF domain). Severity Heat Maps make it easy to identify which subjects had which tissues evaluated and also make it easy to spot trends in incidence or severity. For monochrome printing or for users who are color blind, use the Monochrome checkbox to toggle the display to depict the various severities as shades of grey. The data in the Severity Heat Map visualization can be exported to CSV and all data displayed will be included; however, color-coding is not retained in the export.

Subject View

The Subject View displays selected (or all) endpoints by subject, across domains, in tabular and graphical views. It is not available for SEND Explorer Express; however, sample displays can be seen on the INDS, Inc. website. Contact SENDexperts@inds-inc.com to request a demo of Subject View and other advanced functions available in the SEND Explorer Product family.

Comments and Supplemental Qualifiers

Data from the Comments and Supplemental Qualifier domains have been merged into the associated findings for display in the single-study grid. When Comments or Supplemental Qualifiers are available in a domain, a column for each will appear at the far right of the grid. Records that have associated Supplemental Qualifiers or Comments will have a hyperlinked "Show" as the value in the column. Click on the hyperlink to show the comments or supplemental qualifiers in a popup window. Supplemental Qualifier and Comments data cannot be exported to CSV. Related records associated with a finding can be viewed in the Multi-Study grid.

Excluded Values

Values marked in the .XPT file as excluded from statistical summarization in findings domains include a "Y" the --EXCLFL variable for the row. In SEND Explorer, results where the --EXCLFL field has been set to "Y", the result value contained in --ORRES, --STRESC and/or --STRESN will appear greyed out in the basic, pivoted, and summary displays. If any excluded data values are exported to CSV, the excluded data point will be suppressed and "EX" replaces the excluded value in all appropriate columns (e.g., --ORRES, --STRESC, --STRESN, or the corresponding pivoted columns).

Export to CSV

For SEND Explorer Express, Export to CSV is only available for the included sample datasets. Click the Export to CSV button to export whatever data are currently included in the data grid (except any thumbnail visualization, up/down arrows, or color-coding) to CSV which opens in Excel. The columns in the CSV file will include only those that were selected in the interface, the exported rows will include any which met the filtering criteria, and the order of the rows and columns in the CSV file will reflect the display order in the interface. Additional manipulations of the exported data (filtering, sorting, hiding or reordering columns, pivot tables) can be applied in Excel.

Multi-Study Functionality

Multi-Study Functionality is not available in SEND Explorer Express; however, sample displays can be seen on the INDS, Inc. website. Contact SENDexperts@inds-inc.com to request a demo of Multi-Study functionality and other advanced features available in the SEND Explorer Product family.

Multi-Study Visualizations

Multi-Study Visualizations, including Multi-Study Correlations Matrix, Multi-Study Timecourse Grid, and Multi-Study Histopathology Treemap are not available in SEND Explorer Express. Contact SENDexperts@inds-inc.com to request a demo of multi-study visualizations and other advanced functions available in the SEND Explorer Product family.

Helpful links on the SEND Standard

Additional Assistance

For additional assistance, please contact us at SENDexperts@inds-inc.com

To report a bug, please fill out the Bug Report Form

To request an enhancement, please fill out the Enhancement Request Form