For studies that use a repeat dose study design, SEND Explorer Plus and Warehouse provide the ability to create tabular displays formatted according to the CTD template in ICH section 2.6.7.7. SEND Explorer’s CTD Format View includes several configuration options such as displaying all calculations as group mean, fold of control or % change from control rather than the CTD template standard, grouping data by Sex/Group # rather than Group #/Sex and using original rather than standardized results for gross and histopathology data.
The SEND Explorer option to display data in CTD Format View is ideal for creating CTD tables for repeat-dose studies as well as for QCing CTD tables created by CROs. It is also a valuable tool for creating tabular displays with group means or incidence counts from your SEND datasets. The SEND Explorer CTD Format View display currently does not support clinical observations or animal counts broken down by toxicity vs toxicokinetic animals, but it does support all in-life numeric and pathology endpoints. Additional endpoints can be included and edits made by exporting the data in CTD format to Microsoft Word or Excel.
To create a CTD table for your study, follow the steps below:
Locate a study of interest in the Study Dashboard. In the Study ID column, locate and click on the hyperlinked study number to display the Overview page for the study. From the View pulldown menu at the top upper right, under Single-Study Visualizations, select CTD Format. A tabular report displays that follows the ICH Common Technical Document (CTD) tabular format for repeat-dose toxicity studies. Please note that at this time, the CTD Format view is not available for studies that use a Latin Square or Reproductive Embryo Fetal Development study design.
The “Options”, “Group by” and “Calculations” sections that appear along the top left side of the CTD Format view allow users to limit the display to selected endpoints (those for which the checkbox is selected), to toggle layout from Group #/Sex to Sex/Group#, and/or to determine what calculations should be used for numeric values in the table. By default, “Group by” and “Calculation” options are set to those used in the ICH CTD template for repeat dose toxicity studies.
Select the endpoints to include in your tabular display by clicking the checkbox next to any endpoint. Any endpoints or tissues that have previously been identified for the study as “Endpoints of Interest” will display in the CTD view with a grey-shaded background, making them easy to identify. You can readily navigate to different data types and main study vs. recovery endpoints by clicking on the hyperlinks under Noteworthy Findings on the left-hand side of the display. Once you have selected the endpoints you’d like to include in your tabular display, click “Show selected only” under “Options.”
You may export the filtered (or full) display directly to Word or Excel by clicking on the Export to Word or Export to Excel buttons along the left side of the display. Additional endpoints and edits can be incorporated into the exported file. For tabular displays suitable for Word documents that use portrait orientation, we recommend first exporting the data to Excel, adjusting column widths and font size and removing any extra rows, and then copy/pasting the Excel table into Word.