Create a submission archive for regulatory agencies

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

Show me how!

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:
   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—either one of each form or as a casebook containing all forms, even those that are repeated. See How can I handle blank forms?
   4. To display bookmarks, headers, and labels in Japanese, from the Headings Language drop-down list, select Japanese.
   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. Click Save.
6. Enter the Submission PDF request settings:
   1. If the Enable eTMF download setting appears, select it to 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?
   2. For 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.
   3. Use the Include data as of date and time setting to include all data available at the current date and time or up to (as of) the date and time you enter. The earliest date you can select is the enrollment date of the first subject. See How does the Include data as of date and time option affect the output?
   4. For the Export Selection Criteria setting, 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.
   5. Include or exclude Candidate Queries, preliminary queries issued by a sponsor user and visible only to other sponsor users.
   6. If you have a multilingual study, select the Generate Linking Blank Forms setting to 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.
   7. Click Save.
7. Review your settings and click Submit.
8. To create another request, click Yes, Create Another, or to process this request, click No, Go to Processing Page.
9. 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.

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

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.