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.
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.
|
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. |
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