Previous Topic

Next Topic

Book Contents

Book Index

Submission PDF request settings

The Submission PDF type is most suitable for PDF files to be included in submissions to a regulatory authority. Blank forms are also generated. Password protection is not permitted for submission PDFs and does not appear as an option.

  1. On the PDF Request Settings page, enter the Submission PDF request settings.

    Submission PDF request settings

    Setting

    Choices

    Notes

    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.

    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 records, 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.

    Generate Linking Blank Forms

    Yes or No

    If the study is not multilingual, accept the default, 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.

    To generate linking blank forms, select Yes. Then select the study from the drop-down list.

  2. Click Next.

Copyright © 2016 Oracle and/or its affiliates. All rights reserved.