Create a custom archive

This request type gives you complete control over all settings.

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 Custom 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.
   6. In the Display in the header section, specify the additional information to include in the PDF header. The PDF header, by default includes:
      • Header Text
      • Form Name
      • Form Status
      • Subject No:
      • Generated By
      • Generated Time
   7. Click Next to advance to the Custom PDF request settings page.
5. 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?
6. Select the Share with Sites setting to provide sites with archival PDFs to download. This field appears only if you have the Share with Sites right.
7. 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.
8. 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?
9. 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.
10. Enter the Data Format options:
    1. Select Include Bookmark Prefixes to add a prefix (for example, CRF, Form, Visit, Study) to PDF bookmarks.
    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.
11. Specify Subject and Site Selection options:
    1. 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?
    2. 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.
12. Enter the Form and Visit selection options:
    1. Include all study forms or selected forms in a clinical study. If you include selected forms, you cannot limit the PDF to selected visits.
    2. Include all study visits or selected study visits in a clinical PDF. If you include selected visits, you cannot include selected forms.

       To include common forms across visits you must select the cross visit entry or the forms will be missing from the output.

       1. Select the Select from list radio button.
       2. From the Select visits from list below list, select the cross-trial visit. It might be labeled something similar to Common (Cross Trial).
       3. Use the right-arrow to move it to the Selected List.
       4. Click Save.
13. Specify Study Content options:
    1. For the Transferred Subjects in Current Site Only option, select Yes to create a PDF for a transfer patient in just the current site. Select No to create a PDF for both the originating and the current site. A Subject Record Transfer History document is generated along with the PDF output.
    2. To omit forms without data, select Suppress Empty Clinical Forms. Select No to include all forms, even if they contain no data.
    3. To omit visits without data, select Suppress Empty Clinical Visits. Select No to include all visits, even if they contain no data.
    4. Include or exclude Candidate Queries, preliminary queries issued by a sponsor user and visible only to other sponsor users.
14. To further refine your request, specify these Additional Content options:
    1. To include blank forms (without clinical data), select the Generate Blank Forms setting.
    2. 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.
    3. To create a table of contents as a separate file with links to all generated patient PDFs in the request, select Generate TOC, which is the default choice. The table of contents is sorted by site and then by subject.
    4. To include the Protocol Guide and the CRF Help in the output, select Protocol Guide. Each of these items is a separate PDF.
15. Specify Security options:
    1. To require a password to make changes to the PDF, select Prevent Form Changes. Select System-created: Hidden to permanently prevent form changes to the PDF. Select No to allow PDF output to be modified.
       • This selection disables the Prevent Form Comments Changes and Prevent Content Extracts and Copying options.
       • Passwords are not saved in the application and must be retained.
       • This option cannot be selected if you select Share with Sites.
    2. To prevent comments from being added to the output PDF, select Prevent Form Comments Changes. Select No to allow comments and annotations.
    3. To prevent contents from being copied from the output PDF, select the Prevent Content Extracts and Copying setting.
16. Click Next.
17. Review your settings and click Submit.
18. To create another request, click Yes, Create Another, or to process this request, click No, Go to Processing Page.
19. 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.

20. Select the checkbox and click Download.
21. Review the output.

Tip:

Save time and increase consistency when you need to create multiple custom archives by saving these settings as a template. To do this:

1. On the Review and Submit page, click Save as New Template.
2. Enter a unique name for the template and a description.
3. Click Save.