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Archival PDF request settings

The Archival PDF request type is most suitable for PDFs that will represent study contents for archival purposes. Blank forms are also generated by default.

Use this request type to create a mid-trial archive or final archive and share the archive with one or more sites. The sites can download their PDFs, examine them, and confirm that they have downloaded and reviewed the PDFs.

  1. Enter the Archival PDF request settings.

    Archival 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.

    Share with sites

     

    Yes or No

    No is the default. Select Yes to allow sites to download the archival PDF files. Sponsor users without the Share with Sites right will not see this option.

    Site Confirmation Required

    Yes or No

    This field appears if you select Share with sites.

    If these PDFs are meant for final archival, or MHRA submittal, select Yes to require sites to confirm download of this request. Select No to make confirmation optional.

    Export Selection Criteria

    All Subjects

    By Subject

    By Site

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

    To select subjects from one or more sites, select By Subject. This option does not appear if you select the Share with sites option.

    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.

      Click Save.

      To include all subjects from the selected site, select By Site.

    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 sites 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 50 link.
    5. Continue selecting sites.
    6. Click Save.

    Generate Blank Forms

    Yes or No

     

    Select Yes, the default value, to include blank forms (without clinical data).

    Require Password to Change Document

    Require Password to Change Form Comments

    Require Password to Extract or Copy Contents

    Yes or No

    Password protection is selected by default.

    1. Type the password.
    2. Re-type the password to confirm it.

      The same password is applied to these three options. You can select any or all of them to be password-protected.

    Require Password to extract zip file

    Yes or No

    By default, password protection is not selected. 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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