Oracle Clinical One Platform now stores formatted text values without non-printable characters

Text responses are now stored both in their original format as entered by the site user, and as a formatted value with all non-printable characters removed. The formatted value is used in the Subject Data Extract, Oracle Clinical One Analytics, and downstream integrations; ensuring consistent data integration and minimizing the risk of errors.

Text responses entered by site users may contain non-printable characters, which are invisible symbols that control text formatting. These characters include tabs, carriage returns, newline characters, and leading or trailing white spaces. However, these require additional downstream processing when consumed by downstream systems. Now, this burden is reduced by providing pre-formatted data without these non-printable characters.

As clinical data is extracted from Oracle Clinical One Platform for use in Oracle Clinical One Analytics and downstream integrations, form items get represented in four different columns:

• Raw (ITEM_R)
• Formatted (ITEM_F)
• Decode (ITEM_D)
• The item itself (ITEM)

The Oracle Clinical One Platform system stores the original site entered text in the main ITEM column, for accurate rendering and display within the application. The formatted value, excluding all non-printable characters, is stored in the ITEM_F column.

Note:

This applies to values coming from text questions only.

This change does not impact the data entered or displayed in the application, and it is intended solely to improve data quality and downstream Oracle Clinical One Analytics compatibility. To achieve this, the ITEM_F column now serves as the standardized, analytics-ready version for downstream integrations, exports, and data pipelines.

You can find additional information in Form item output mapping in data extracts, in the Analytics User Guide, after the Release Assessment Environment (RAE) upgrade.

Impact on integrations

There would be no impact if you are working with Oracle Clinical One Digital Gateway or Oracle CRF Submit.

However, if you are working with Oracle Central Coding, you must consider that after the upgrade to 26.0.1, Oracle Clinical One Platform will send the formatted text value (without non-printable characters) to Oracle Central Coding for all newly entered verbatim terms (VTs) and any VTs that were coded before the upgrade and edited after. Users may be required to manually code new and edited VTs.

Note:

Keep in mind manual re-coding is only needed if the VT and its associated context items in fact include non-printable characters. This can sometimes happen if a user pastes text into one of the text fields in the study, resulting in the introduction of non-printable characters into the field.

If VTs were entered before the upgrade but coded afterward, Oracle Central Coding codes them using the pre-upgrade 'raw' text, and subsequent matching VTs auto-code based on the same text.

Already working in a live study?

For existing text responses, the original data stored in the ITEM_R column (and displayed in the application) remains unchanged. Oracle Clinical One Platform will only generate and populate the corresponding ITEM_F data by processing the stored values and removing all non-printable characters:

• These updates to the ITEM_F column will be performed as a post-upgrade activity.
• Data will be updated irrespective of the current data status (locked, frozen, signed, read-only, hidden, etc.), and will not trigger any actions, such as unsign, unverify, auto-lock or other rules.
• After the upgrade, the first incremental load may take several hours to complete as it pushes these updates into Data Hub and Oracle Clinical One Analytics. This is part of the Oracle Clinical One Analytics data pause, which will be announced as it ends.

Any future updates or edits to existing responses will continue to automatically update in all four ITEM, ITEM_R, ITEM_F, and ITEM_D columns.