Pre-General Availability: 2025-07-15

Oracle CRF Submit Archives requests include uploaded documents

Now, when you generate Oracle CRF Submit Archives requests, the request output includes documents that were uploaded to a question.

Oracle Clinical One Platform 25.2 introduces the new File Upload question type, which enables study designers to include questions on forms that allow users to upload documents, such as images. For more information about this enhancement, see Upload and store any documents for your study.

Details for sponsors and site users

  • For Custom requests:
    A new setting, Include Uploaded Files, is available on the Advanced Settings page. No new permissions are needed to use this setting.
    • When set to Yes (default), the uploaded documents are included in the Uploaded Files folder, which can be located in the site folder in the main zip file. Additionally, the subject PDFs contain the document title and a View link for questions related to the upload. Upon clicking, the system displays the relevant document.

      Note:

      The document title naming convention is documentID_documentversion_filename.extension.
    • When set to No, the documents are not included in the Uploaded Files folder, and a View link is not provided; only the document title is displayed on the questions related to the upload.
  • For Submission, Archival (for sponsor users), and Archival (for site users) requests:
    The setting is visible on the Advanced Settings page; it is set to Yes by default and cannot be changed.
    • The uploaded documents are included in the Uploaded Files folder, which can be located in the site folder in the main zip file. Additionally, the subject PDFs contain the document title and a View link for questions related to the upload. Upon clicking, the system displays the relevant document.
  • All archive requests include a set of blank forms for each study version. File Upload-type questions are marked with the File Upload label.

Limitations

If the title of an uploaded document includes multi-byte characters, such as Japanese and Simplified Chinese characters, Archive requests fail to generate.

How can I be certain I'm getting the most relevant documents?

The As of Date setting (available on the Settings side panel) determines which documents are included with the request.
  • If you select Now, the View link is associated with the most recently uploaded document. Details about previous uploads and links to the associated documents can be found in the Audit Trail by CRF section of the PDF.
  • If you select a specific date for Select Date/Time, the View link is associated with the document that was uploaded on or before the date selected. Details about previous uploads and links to the associated documents can be found in the Audit Trail by CRF section of the PDF.

Note:

If you delete the last uploaded document, the question will no longer display the View link and document name. You can view the Audit Trail by CRF section of the PDF to see details for all uploaded documents. This section also includes a View link for each uploaded document.

Will the View links work if my request exceeds 200 MB?

If your request's total output surpasses 200 MB, Oracle CRF Submit divides the output into multiple zip folders to facilitate their download. If such an event occurs, the possibility exists that the subject PDF and the uploaded documents may end up in two different zip folders.

Tip:

In order for the View links to work, you must extract all of the contents of the zipped folders to the same location. To achieve this, right-click each zipped folder, then select Extract All and follow the instructions in the extraction wizard.

You can find additional information in the Reporting Guide after the Release Assessment Environment (RAE) upgrade.

Parent topic: Reporting, archives and analytics