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

Submission PDF

At the conclusion of a study, generate this type of request for submission to the FDA and other regulatory agencies. The information is automatically compiled and formatted according to the regulators' requirements. The output contains data visible to the user who creates it based on their assigned rights group.

Tip:

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

Here's what a Submission 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.

Follow the steps below to create a Submission PDF

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 Submission 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 2-1 Submission 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.
  4. Complete the Request Settings, then click Next.

    Table 2-2 Submission PDF Request Settings

    Setting Details
    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 Subject
    • By Site

    For more information, see How do I define the Export Selection Criteria?, and How do I enter a large number of subjects?
    Candidate Queries
    • Select Yes to include Candidate Queries in PDFs.
    • Select No (default) to exclude them.
    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.
    Prevent Form Changes Not editable for this request type, displayed for information purposes only.
    Prevent Form Comments Changes
    • Select Yes to prevent comments and annotations from being added to the output PDF.
    • Select No (default) to allow comments or annotations.
    Prevent Content Extracts and Copying
    • Select Yes to prevent content being copied from the output PDF.
    • Select No (default) to allow content to be copied.
  5. Review the request settings displayed on the Review and Submit page for accuracy.
    • 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