Visualizing STF Content in a Browser Using the ICH Stylesheet

Currently we are receiving many support questions regarding an issue that arises when displaying STF study reports in a browser using the new stylesheet version 2-3. We would like to explain the background and why we need to wait until ICH issues another official stylesheet to correct this.

Background: In June 2017, the ICH M8 group issued a new STF stylesheet, version 2-3. This stylesheet, which allows the visualizing of STF XML objects in a browser, was adopted by the USFDA on November 15, 2017, and is today a mandatory item when submitting eCTD submissions with STFs.

Under certain conditions, this new STF stylesheet generates an error and prevents the display of the complete STF study report in a browser.

It would be a technically easy task to modify the stylesheet; however, since the present stylesheet is currently valid and “in-force”, its modification will require a formal change by the ICH enabling a new official stylesheet to be used. Using a corrected but non-official version of the stylesheet will lead to validation errors.

That means we need to wait until ICH issues another official stylesheet to correct this issue.

If you would like to understand the details and the source of this error, please click here.

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