Create a custom archive

This option gives you complete control over all settings.

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

From the Create Requests drop-down menu, click Create New PDF Request.
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.
Enter a Description (optional), select Custom PDF, and click Next.
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.
6. In the Display in the header section, specify the information to appear at the top of each PDF output page. You can turn on an off the information shown.
  The following fields always appear:
  - Header Text
  - Subject ID
  - Form Name
  - Form Status
Enter the Custom 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?
- Share with Sites—Select Yes to provide sites with archival PDFs to download. This field appears only if you have the Share with Sites right.
- Site Confirmation Required—If these PDFs are meant for final archiving, or an MHRA site audit, select Yes to require sites to confirm download and review of this request.
- Select the rights group to control content—This field appears if you select Share with Sites. 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?
- Include Bookmark Prefixes—Adds a prefix (for example, CRF, Form, Visit, Study) to PDF bookmarks.
- 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.
- Forms—Include all study forms or selected forms in a clinical study. If you include selected forms, you cannot limit the PDF to selected visits.
- Visits—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.
- Transferred Subjects in Current Site Only—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.
- Suppress Empty Clinical Forms—Select Yes to omit forms without data. Select No to include all forms, even if they contain no data.
- Suppress Empty Clinical Visits—Select Yes to omit visits without data. Select No to include all visits, even if they contain no data.
- Candidate Queries—Include or exclude these preliminary queries issued by a sponsor user and visible only to other sponsor users.
- Generate Blank Forms—Select Yes to include blank forms (without clinical data).
- 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.
- Generate TOC—Select Yes, the default value, to create a table of contents as a separate file with links to all generated patient PDFs in the request.
- Protocol Guide—Select Yes to include the Protocol Guide and the CRF Help in the output. Each of these items is a separate PDF.
- Prevent Form Changes—Select Yes to require a password to make changes to the PDF. 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.
- Prevent Form Comments Changes—Select Yes to prevent comments from being added to the output PDF. Select No to allow comments and annotations.
- Prevent Content Extracts and Copying—Select Yes to prevent contents from being copied from the output PDF.
Review your settings and click Submit.
To create another request, click Yes, Create Another, or to process this request, click No, Go to Processing Page.
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.
Select the checkbox and click Download.
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:

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