Create a submission archive for regulatory agencies

Previous Topic

Next Topic

Book Contents

Create a submission archive for regulatory agencies

The Submission PDF type is most suitable for PDF files to be included in submissions to a regulatory authority. Blank forms are also generated.

Video icon Show me how!

Tip Tip: Create this archive as a test run to make sure that the PDF output contains the data that you need.

  1. From the Create Requests drop-down menu, click Create New PDF Request.
  2. On the Study Information page, accept the default PDF Request Name (composed of the study name and the current date-time) or enter a different name.
  3. Enter a Description (optional), select Submission PDF, and click Next.
  4. Complete the Forms Options page and click Next.
    1. Enter Header Text to appear at the top of each form in the PDF output. The default is the study name.
    2. Select a Page Size, either Letter (8-1/2 " by 11") or A4 (European letter size: 210 x 297 mm).
    3. Specify the Blank Form Format. See How can I handle blank forms?
    4. To display bookmarks, headers, and labels in Japanese, select Japanese from the Headings Language drop-down list.
    5. In the Footer Text field, enter up to 30 characters to alternate left and right on all pages of the PDF output. If no footer is specified, the footer on each page of the PDF is ***Confidential***, along with page numbers; e.g., Page 1 of 115.
  5. Enter the Submission PDF request settings and click Next.
    • Enable eTMF download—Make the PDF output available where someone with the eTMF right can access it. See Can I make the PDF output available to an eTMF system?
    • Audit Location—Identify the location of the audit trail history information in the PDF output: either after each form or at the end of the PDF.
    • Include data as of date and time—The data includes all data available at the current date and time or up to (as of) the date and time you enter. See How does the Include data as of date and time option affect the output?
    • Export Selection Criteria—Select All Subjects, By Subject, or By Site and click Save. See How do I define the Export Selection Criteria? To select a large number of subjects, import them from a CSV (comma-separated value) file.
    • Candidate Queries—Include or exclude these preliminary queries issued by a sponsor user and visible only to other sponsor users.
    • Generate Linking Blank Forms—For multilingual studies, link a blank form in another language to a study form. This enables a reviewer who is unfamiliar with the language on the original form to view the form structure in another language.
  6. Review your settings and click Submit.
  7. To create another request, click Yes, Create Another, or to process this request, click No, Go to Processing Page.
  8. You can monitor the progress on the My Requests - Processing page.
    • To update the processing statistics shown, click Refresh.
    • To pause processing, select a request checkbox and click Pause. To resume processing, click Resume.
    • To cancel the request, select a request checkbox and click Cancel.

    When the request disappears from the My Requests - Processing page and moves to the My Requests - Completed page, processing is complete.

  9. Select the checkbox and click Download.
  10. Review the output.

Tip Tip: The PDF Request Name appears on lists of Processing, Completed, Saved, and Deleted PDF requests. The name can contain blank spaces, but no special characters. For example, Mass General Blank Forms.

Send Feedback