Header Text

Custom text that appears in the table header. Default is the InForm study name. Required.

Include Supplementary Page Header

Indicates whether to include a page header and footer. The header displays information taken from the InForm study, including:

• Visit name
• Form version
• Subject initials
• Subject number

  The footer includes the CRF Submit URL that was used when the page was generated.

Include Bookmark Prefixes

Include prefixes in the bookmarks. For example, in a bookmark for CRF:Date of Visit (DOV), CRF: is the bookmark prefix.

Include Form Status

Include the status of the form in the PDF.

Page Size

Specify the page sizes for the PDF file. Required.

• Letter—8.5 x 11 inches. Default.
• A4—210 mm x 297 mm.

One File per

Specifies how to arrange data and save the PDFs.

• CRB—Data is arranged and saved on a subject by subject basis. One PDF is created per subject.
• Visit—Data is arranged and saved on a visit by visit basis. One PDF is created per visit per subject.

  Note: This option only applies to forms with data. Blank forms are always generated by study version.

Audit Location

Specifies where in the PDF you want to format the Comments, Signatures, and Audit Trails:

• After Each Form
• At End of PDF

File Format

Specifies the formats in which to save the data.

• PDF
  • Verify PDF After Generation—Run a post-processing script that verifies that the CRF Submit application generated a valid PDF file for every subject in the InForm study and that the bookmarks work correctly. Default.
  • Reduce File Size—Run the Reduce File Size option in Adobe Acrobat. If selected, specify a minimum file size for the process to run. Default is 100 MB.

    Note: If you select the Reduce File Size option, the PDF files are only viewable with Adobe Reader version 6.0 and higher.

• XML
• HTML

Require Password to Change Document

Prevent changes to the PDF file. If you are creating a site archive, it is recommended that you select this option.

Require Password to Change Form Comments

Prevent data from being added to the PDF file. If you are creating a site archive, it is recommended that you select this option.

Note: If you select both the Require Password to Change Document and the Require Password to Change Form Comments options, active controls will not be enabled and their options will not be visible in generated blank form PDFs.

Require Password to Extract or Copy Contents

Prevent copying or exporting data from the PDF file.

Note: This option prevents an index from being created. If you plan to generate an index for this PDF, do not select this option. Regulatory guidelines state that you should not include any security settings or password protection for submission PDF files.

Password

Specifies a password. If you use any of the Adobe security options, you must specify a password. This allows access to the security options within the PDF so that changes can be made at a later date.

Note: The security options have no effect on the ability to open and view a PDF file. Regulatory guidelines state that you should not include any security settings or password protection for submission PDF files.

Re-enter Password

Re-enter the password for password protected fields in order to confirm that the original password entered is correct.

Display passwords in plain text

Display the text entered in the Password and Re-enter Password fields.

Transferred Subjects in Current Site Only

Indicates whether to include only those subjects in the current site who have been transferred between sites.

Suppress Blank Forms

Omit forms for which no data has been entered. If this is not selected, any forms that were dynamically created in the InForm application appear in the PDF. If a form was not created in the InForm application, it does not appear in the PDF.

Note: If you are generating a set of blank forms, only those dynamic forms and visits that exist in the selected study version are included in the PDF.

Suppress Blank Visits

Omit visits for which no data has been entered. Otherwise, any visits that have been dynamically created in the InForm software will appear in the PDF. If a form has not yet been created in the InForm software, it will not appear in the PDF.

Note: Blank forms do not contain subject data. Therefore, the bookmark for a blank form references the visit, but not the subject. For example, a repeating visit that appears as Day 1 1 in a subject PDF will appear as Day 1 0 in the blank study form.

Candidate Queries

Include candidate queries.

Note: A candidate query is visible in InForm only to those users who have appropriate rights (for example a CRA).

Generate Index

Create a PDX (index) file for a set of PDFs. If you generate an index, you can use the Adobe Acrobat search feature to search PDFs by keyword. Required.

Protocol Guide and CRF Help

Generate the Protocol Guide and the CRF Help into separate PDF files.

Generate TOC

Create a table of contents for all the information generated in this work order.

Generate Linking Blank Forms

Generate a set of blank forms to use for reference with PDF files, typically for a multilingual study. If you select this option, specify the language for the blank forms. Typically, these forms are in a different language than the submission language. The Generate Linking Blank Forms drop-down list is automatically populated with the languages used in the InForm study.

Note: The Generate Linking Blank Forms option only works with the InForm GTM (InForm 4.7, InForm 5.x, and InForm 6.x) releases. If you select the Generate Linking Blank Forms option for a study created in the InForm ITM (InForm 4.5 and InForm 4.6) release streams, the CRF Submit user interface displays an error message.

Generate Blank Forms

Extract a complete set of forms without subject data.

Blank Form Format

Specify the organization for the PDF files:

• Unique Forms—One copy of each unique form in the study version arranged alphabetically.
• Casebook—Copies of all the forms in the study version arranged as they appear in the casebook. Default.

Study Versions

If you do not want to generate blank forms for all study versions, specify study versions for which to generate blank forms.

Hidden Item Option

If you do not want to include items that are hidden to certain rights groups in the InForm study, select which hidden items to exclude. Use the search box to search for a rights group.

• Hide None—Default.
• Hide All—Exclude all items that are hidden to any rights group.
• Hide Selected—A list of all the rights groups in the InForm study appears.

  Select a rights group to exclude items hidden to it.

  Note: To select more than one rights group, click multiple groups.

Form Selection Options

If you do not want to extract data from all forms, specify the forms whose data you want to export. Use the search box to search for a form. Hover over a form to view the RefName of the form.

Visit Selection Options

If you do not want to export data from all visits, specify the visits whose data you want to export. Use the search box to search for a visit.

Selection Criteria

If you do not want to extract data from all subjects and sites, specify the subjects or sites whose data you want to export. Use the search box to search for a subject or site.

• Export by Subject—A list of all the subjects in the InForm study appears.

  Select the subject for which you want to extract data.

  Note: To select more than one subject, click multiple subjects.

• Export by Site—A list of all the sites in the InForm study that the InForm user has access to appears.

  Select the site for which you want to extract data.

  Note: To select more than one site, click multiple sites.

  Data is extracted for all subjects in the selected sites.

All

Selects all rights groups for hidden item selection.

Selects all sites, subjects, forms, or visits when exporting by site, subject, form, or visit.

Reverse

Selects the unselected rights groups and deselects the selected rights groups for hidden item selection.

Selects the unselected sites, subjects, forms, or visits and deselects the selected sites, subjects, forms, or visits when exporting by site, subject, form, or visit.

Right arrow icon

Move the selected rights groups to the Selected Rights Groups list.

Move the selected sites, subjects, forms, or visits to the Selected Sites list, Selected Subjects list, Selected Forms list, or Selected Visits list

Left arrow icon

Remove the selected rights groups from the Selected Rights Groups list.

Remove the selected sites, subjects, forms, or visits from the Selected Sites list, Selected Subjects list, or Selected Forms list, or Selected Visits list.

Back

Navigate back to the previous page.

Next

Navigate to the next page. You must enter all of the required fields before you can move on.

Cancel

Cancel the work order and return to the Monitor page.

Return to Monitor

Navigate to the Monitor page.

Configuration icon

Navigate to the Configuration Options page.

Help icon

Open the context-sensitive Help.