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Custom PDF request settings

The PDF Request Settings page appears after you have specified the study information and form options. It provides control over settings grouped into the following categories:

  1. Enter the Custom PDF request settings:

    Custom PDF request settings

    Option

    Choices

    Notes

    eTMF Integration:

    Enable eTMF integration

    Yes or No

    Makes the PDF output available where someone with the eTMF right can access it.

    Appears only if eTMF integration has been enabled on the Settings page. For more information, see Specifying trial, email, and storage settings.

    Data Format:

    Include Bookmark Prefixes

    Yes or No

    Adds a prefix (for example, CRF, Form, Visit, Study) to PDF bookmarks.

    Data Format:

    Audit Location

    After Each Form or End of PDF

    Identifies the location of the audit trail history information in the PDF output.

    Subject and Site Selection:

    Export Selection Criteria

    All Subjects

    By Subject

    By Site

    The default is All Subjects. This choice includes everything in the study.

    You can select subjects from multiple sites and bulk load subjects from a file.

    If you select By Subject, the Select Subjects dialog box appears.

    1. From the Select a site to filter drop-down list, select a site.

      The subjects associated with the selected site appear in the subjects list.

    2. (Optional) In the Select subjects from list below text box, search for subjects by typing at least three characters of the subject ID.

      The subjects that match the filter appear in the list.

    3. Using the Shift and CTRL keys, highlight the subjects you want to include, and click the right arrow.

      The selected subjects move to the Selected List.

    4. To scroll through the subjects list, click the Get Next 500 link. If there are no more subjects, this link does not appear.
    5. Continue selecting subjects.
    6. To select subjects from another site, from the Select a site to filter drop-down list, select the site.
    7. Follow the instructions in steps 2 through 6.
    8. Click Save.

    If you select By Site, the Select Sites dialog box appears.

    1. In the Select sites from list below text box, search for a site by typing at least three characters of the site name.

      The sites that match the filter appear.

      Or

    2. From the list below the Select sties from list below text box, use the Shift and CTRL keys to highlight the sites you want to include.
    3. Click the right arrow.

      The sites appear in the Selected List.

    4. To scroll through the sites list, click the Get Next 500 link. If there are no more records, the link does not appear.
    5. Continue selecting sites.
    6. Click Save.

    Form Selection:

    Forms

    All or Select from list

    Include all study forms or selected forms in a clinical study.

    If you include selected forms, you cannot limit the PDF to selected visits.

    If you select Select from list, the Select Forms dialog box appears.

    1. In the Select forms from list below text box, search for a form by typing at least three characters of the form name.

      The forms that match the filter appear.

      Or

    2. From the list below the Select forms from list below text box, use the Shift and CTRL keys to highlight the forms you want to include.
    3. Click the right arrow.

      The forms appear in the Selected List.

    4. To scroll through the forms list, click the Get Next 500 link. If there are no more records, the link does not appear.
    5. Continue selecting forms.
    6. Click Save.

    Visit Selection:

    Visits

    All or Select from list

    Include all study visits or selected study visits in a clinical PDF.

    If you include selected visits, you cannot include selected forms.

    If you select Select from list, the Select Visits dialog box appears.

    1. In the Select visits from list below text box, search for a visit by typing at least three characters of the visit name.

      The visits that match the filter appear.

      Or

    2. From the list below the Select visits from list below text box, use the Shift and CTRL keys to highlight the visits you want to include.
    3. Click the right arrow.

      The visits appear in the Selected List.

    4. To scroll through the visits list, click the Get Next 500 link. If there are no more records, the link does not appear.
    5. Continue selecting visits.
    6. Click Save.

    Study Content:

    Transferred Subjects in Current Site Only

    Yes or No

    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.

    Study Content:

    Suppress Empty Clinical Forms

    Yes or No

    Select Yes to omit forms without data. Choose No to include all forms, even if they contain no data.

    Study Content:

    Suppress Empty Clinical Visits

    Yes or No

    Select Yes to omit visits without data. Select No to include all visits, even if they contain no data.

    Study Content:

    Candidate Queries

    Yes or No

    Select Yes to include candidate queries.

    Additional Content:

    Generate Blank Forms

    Yes or No

    Select Yes to include blank forms (without clinical data).

    If Yes, The Study Version field appears. To include all studies, select All. To select the study version from a list of studies, select Select from list.

    Additional Content:

    Generate Linking Blank Forms

    Yes or No

    Yes allows you to link a blank form associated with a study version in a different language. This enables a reviewer who is unfamiliar with the language on the original form to view the form structure in another language. The actual clinical data, however, is always in the entered language. For example, if a form is designed in Spanish and this setting has been selected, the user can click a link to view an equivalent form in another language.

    Select Yes, then select the study from the drop-down list.

    Additional Content:

    Generate TOC

    Yes or No

    Select Yes to create a table of contents as a separate file with links to all generated patient PDFs in the request.

    Additional Content:

    Protocol Guide

    Yes or No

    Select Yes to include the Protocol Guide and the CRF Help in the PDF.

    Security:

    Require Password to Change Document

    Password to Change Form Comments

    Password to Extract or Copy Contents

    Yes or No

    Password protection is turned off by default. To include password protection on any or all of these options:

    1. Click the Yes radio button.
    2. Type the password.
    3. Re-type the password to confirm it.

    Security: Require Password to extract zip file

    Yes or No

    Password protection is turned off by default. To include password protection:

    1. Click the Yes radio button.
    2. Type the password.
    3. Re-type the password to confirm it.

  2. Click Next.

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