Create an archival PDF for a milestone or completed study

Use this request type to create a mid-trial archive or final archive and share the archive with one or more sites. The sites can download their PDFs, examine them, and confirm that they have downloaded and reviewed the PDFs. Blank forms are also generated by default.

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 Archival 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 Next.
6. Enter the Archival 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?

      Tip:

      This option only can be set to Yes when Share with Sites is set to No.
7. Select the Share with Sites option to provide sites with archival PDFs to download. This field appears only if you have the Share with Sites right.
8. If you choose Share with Sites, select Site Confirmation Required if these PDFs are meant for final archiving, or an MHRA site audit, to require sites to confirm download and review of this request.
   1. Select the rights group with control over the content of the request type. The default is the logged-in user's rights group. See What do rights groups do?
   2. Select Yes for Allow Any Site User to Download the Request Output to allow any site user with Archives access to download request output. Select No to allow only site users assigned to the rights group selected for Select the Rights Group to Control Content to download the request output.
   3. 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.
   4. 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?
   5. 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.
   6. Include or exclude Candidate Queries, preliminary queries issued by a sponsor user and visible only to other sponsor users.
   7. To include blank forms (without clinical data), select the Generate Blank Forms setting.
   8. To prevent comments and annotations from being added to the output PDF, select the Prevent Form Comments Changes setting.
   9. To prevent contents from being copied from the output PDF, select the Prevent Content Extracts and Copying setting.
9. Click Save.
10. Review your settings and click Submit.
11. To create another request, click Yes, Create Another , or to process this request, click No, Go to Processing Page.
12. 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.

13. Select the checkbox and click Download.
14. Review the output.