1. User Guide for Sponsors
  2. Create an archive
  3. Custom PDF

Custom PDF

This request type gives you access to all settings, letting you control what to include in the output.

Tip:

You can generate a Test Run first to ensure the PDF output contains the correct data.

Here's what a Custom PDF request includes

  • One folder per site, each containing one PDF per subject.
  • A Table of Contents (TOC).
  • A PDF containing the Request Settings.
  • A set of blank forms with active controls for each study version.

    Note:

    Blank forms are included only when the Request Setting Generate Blank Forms is Yes.

Follow the steps below to create a Custom PDF request

Start by accessing Oracle InForm CRF Submit.

  1. On the My Requests - Processing page, click Create Requests, then select Create New PDF Request.
  2. On the Study Information page, update the PDF Request Name (if applicable), enter an optional PDF Request Description, select Custom PDF, and click Next.

    Note:

    The request name defaults to the study name plus the current date and time.
  3. Complete the Form Options, then click Next.

    Table 2-7 Custom PDF Form Options

    Option Details
    Header Text
    • Enter text up to 90 characters to appear at the top of each page on the PDF.
    • The study name is the default value.
    Page Size
    • Letter: (default) 8-1/2" by 11"
    • A4: European letter size: 210 x 297 mm
    Blank Form Format
    • Unique Forms: One of each form in your study.
    • Casebook: (default) All forms, even those that are repeated.

    Note:

    For more information, see How can I handle blank forms?.
    Headings Language
    • Specify the language to use for labeling bookmarks, headers, and footers.
    • English is the default language.
    Footer Text
    • Enter text up to 30 characters to appear in the footer of each PDF page.
    • ***Confidential*** along with page numbers is the default.
    Include Study Name in the Subject PDF File name
    • Select Yes (default) for the Study Name to appear in the Subject PDF file name.
    • Select No if the study name is not needed.
    Display in the header By default, the PDF header includes, Header Text, Form Name, Form Status, Subject No., Generated By, and Generated Time. You can also include the following in the header.
    • Form Version (default is Yes)
    • Subject Initials (default is Yes)
    • Visit Name and Number (default is Yes)
    • Site Name and Number (default is Yes)
    • Sponsor (default is No)
    • Protocol (default is No)
  4. Complete the Request Settings, then click Next.

    Table 2-8 Custom PDF Request Settings

    Setting Details
    Allow PDF request to be stored in eTMF

    Note:

    This setting is only available when the trial setting Enable eTMF Download is enabled.
    		For more information about this setting, see About Electronic Trial Master File (eTMF).
    Share with Sites

    Note:

    Appears only if you belong to a rights group with the Share Archives with Sites right.
    • Select Yes if you want to make the PDFs made available for download by site users.
    • Select No (default) if site users do not need to download this request.
    Site Confirmation Required

    Note:

    Appears only if Share with Sites is Yes.
    • Select Yes (default) if you want site users to confirm downloading a request shared with them.

      Note:

      For more information about the site confirmation process, see Confirm archives and reports.
    • Select No if you do not require confirmation from site users.
    Select the rights group to control content
    • The rights group selected determines what content gets included in the PDF output.
    • The default is the logged-in user's rights group.
    Allow any Site User to download this request

    Note:

    Appears only if Share with Sites is Yes.
    • Select Yes to allow any site user with Archives access to download a request.
    • Select No (default) to allow only site users assigned to the rights group selected for Select the Rights Group to Control Content to download the request.
    Notify CRFS Site Users

    Note:

    Appears only if Share with Sites is Yes.
    • Select Yes to send site users the, PDF or History Request is available for download (Site user, when share with sites) notification when a request is available for download.

      Note:

      The notification is only sent if it has been enabled. For more information, see About email notifications. The setting displays even if the notification is not enabled.
    • Select No (default) if the notification should not be sent.
    Include Bookmark Prefixes
    • Select Yes to include prefixes (for example CRF, Form, Visit, Study) in PDF bookmarks.
    • Select No (default) if bookmark prefixes are not needed.
    Audit Location
    • Select After Each Form to place audit trail data at the end of each form.
    • Select End of PDF (default) to place it at the end of the PDF.
    Include data as of date and time
    • Select Now (default) to include all data available up to the date and time displayed.
    • Select Select date/time to enter a specific date.

      Note:

      The date cannot be before the first subject’s study enrollment date.

    For more information, see How does the Include data as of date and time option affect the output?.

    Export Selection Criteria
    Select to create PDFs for
    • All Subjects (default)
    • By Site

    For more information, see How do I define the Export Selection Criteria?, and How do I enter a large number of subjects?.

    Forms
    • Select All (default) to include all forms.
    • Select Select from list to include selected study forms in the output.

      Note:

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

    Note:

    To include common forms across visits you must select the cross visit entry or the forms will be missing from the output.
    • Select All (default)
    • Select Select from list to include selected study visits in the output.

      Note:

      If you include selected visits, you cannot include selected forms.
    Transferred Subjects in Current Site Only
    • Select Yes to create a PDF for a transfer subject in just the current site.
    • Select No (default) to create a PDF for both the originating and the current site.

    For more information, see Where is subject transfer history included?.

    Suppress Empty Clinical Forms
    • Select Yes to omit forms for which no data has been entered.
    • Select No (default) to include all forms, even if they are empty.
    Suppress Empty Clinical Visits
    • Select Yes to omit visits for which no data has been entered.
    • Select No (default) to include all visits, even if they are empty.
    Candidate Queries
    • Select Yes (default) to include Candidate Queries in PDFs.
    • Select No to exclude them.
    Generate Blank Forms
    • Select Yes to include blank forms.
    • Select No (default) to exclude them.
    Study Version

    Note:

    Appears only if Generate Blank Forms is Yes.
    • Select All (default) to create blank forms for all study versions.
    • Select Select from list to choose specific study versions.
    Generate Linking Blank Forms

    Note:

    For multilingual studies.
    • Select Yes to link a copy of the blank form in another language to this form.
    • Select No (default) to not link a copy of the blank form.
    Generate TOC
    • Select Yes (default) to include a table of contents (TOC) with links to all generated subject PDFs in the request.
    • Select No to not include the TOC.
    Protocol Guide
    • Select Yes to include the Protocol Guide and the CRF Help in the PDF Request output.
    • Select No (default) to exclude the Protocol Guide and CRF Help.
    Prevent Form Changes
    • Select Yes to require a password to make changes to the PDF.

      Note:

      When set to Yes a field appears allowing you to define a password.
    • Select System-created : Hidden to permanently prevent form changes to the PDF.

      WARNING:

      This password cannot be retrieved.
    • Select No (default) to allow PDF output to be modified.
    Prevent Form Comments Changes
    • Select Yes to prevent comments and annotations from being added to the output PDF.
    • Select No (default) to allow PDF comments or annotations.
    Prevent Content Extracts and Copying
    • Select Yes to prevent contents being copied from the output PDF.
    • Select No (default) to allow content to be copied.
    Password

    Note:

    Appears only when Prevent Form Changes is set to Yes.
    		Specify a password to be used when Prevent Form Comments Changes and Prevent Content Extracts and Copying are set to Yes.

    WARNING:

    The password entered is not saved in the application and must be retained by the user.
    Re-enter Password Re-enter the password exactly as entered in the Password field.
  5. Review the request settings displayed on the Review and Submit page for accuracy.
    • Click Save as New Template to save the request as a template for future use. Templates are saved under Templates - Manage Templates.
    • Click Save to save the request to the Saved tab under My Requests. You can access this request later to make edits and generate it.
    • Click Print to print a copy of the request settings. The zip file also includes a copy of the request settings.
    • Click Submit to generate the request.
  6. The PDF Request Submitted window opens and presents the following options.
    • Click Yes, Create Another to return to the Create New PDF Request page.
    • Click No, Go to Processing Page to be taken to the My Requests - Processing page.
  7. On the My Requests - Processing page, click Refresh until the % Complete column displays 100.

    Note:

    Completed requests are moved to the My Requests - Completed page.
  8. You can now Download the PDF.

Parent topic: Create an archive