Submission PDF

Users assigned to a sponsor study role typically use this archive type for submission to the FDA and other regulatory agencies at the conclusion of a study. The information is automatically compiled and formatted according to the regulators' requirements.

Subject data in the output files match the data the user making the request can see in the user interface. For more information about how to generate a request, see Generate an archive or report.

The request output ZIP file contains the following:
  • A folder for each site containing PDFs for each subject.

    Note:

    Subject transfer history files (.prth files) are also included for transferred subjects.
  • A set of blank PDFs containing active controls for each study version.
  • A table of contents PDF.
  • A request settings PDF outlining the settings used to generate the archive.

Modes

Available only in Testing and Production mode. To get started, Access the Reports & Archives page.

Required permissions

Users assigned to a sponsor study role that includes the following permission can generate this archive.
  • Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation

Settings

Setting Details
Name Enter a unique name (alphanumeric characters only) that does not exceed 64 characters.
As of Date
  • Select Now (default) to include all data from the beginning of your study until the date displayed.

  • Select Select Date/Time to enter a specific date. The output includes all data up to and including the date entered.

    Note: The date selected must be after the date when the first study version was created.
Included in Report
  • Select All Subjects (default) to include data for all enrolled subjects in the request output.

  • Select Select Subjects to include data for specific enrolled subjects in the request output.

    Note: If a subject number was changed, the As of Date setting determines what value is presented in the drop-down.

  • Select Select Sites to include data from specific sites in the request output.

    Note: You see the following when sites included in the archive have no subjects.
    • When hovering over the Request Settings icon to the left of the request name on the Download Archives sidebar, you see all sites included in the archive, even those without subjects.
    • The Zip file includes folders for only those sites with subjects. Also, the Table of Contents and the Request Settings PDF, included in the zip file, only include sites with subjects.
Page size
  • Letter (default) 8-1/2" by 11"
  • A4 European letter size: 210 x 297 mm
Blank Form Format
  • Select Casebook (default) to show all forms in every visit.
  • Select Unique Forms to show one of each blank form in every visit.
Header Text
  • Enter up to 90 characters to appear at the top of each page.
  • The study name is the default.
Footer Text
  • Enter up to 30 characters to appear at the bottom of each page.
  • **Confidential** is the default.

Advanced settings

To access the Advanced Settings, select Advanced at the bottom of the Settings sidebar.

Advanced setting Details
  • Include RTSM Data
  • Include Subject Event Data

These settings work together to determine what data to include in the request output.

The default for both settings is No.

  • If Include RTSM Data is set to Yes and Include Subject Event Data is set to No,
    • The PDF includes a section labeled Subject Randomization History, which displays the randomization number and the date and time of randomization.
    • The PDF also includes a section labeled Visit History, which displays kit and dispensation details. For additional information, see the Dispensation details section below.
  • If Include RTSM Data is set to No and Include Subject Event Data is set to Yes,
    • The PDF includes a section labeled Subject Event History, which displays each event (under the Action column) and the date and time of occurrence, as well as other subject event details (under the Details column). For a complete list of details, see About the Advanced Setting—Include Subject Event Data.
  • If both are set to Yes,
    • The PDF includes a section labeled Subject History, which displays each event (under the Action column) and the date and time of occurrence, as well as other subject event details (under the Details column). For a complete list of details, see About the Advanced Setting—Include Subject Event Data.
    • The PDF also includes a section labeled Visit History, which displays kit and dispensation details. For additional information, see the Dispensation details section below.

  • If both are set to No, nothing appears in the request output.

Include Uploaded Files

The setting is defaulted to Yes and cannot be changed.

Some form questions allow users to upload documents, such as images. By default, these documents are included in the request output. For more information, see About the Advanced Setting—Include Uploaded Files.

Security settings
The security settings for this request type are set to No and are locked by default.
  • The Prevent Form Changes setting controls the ability to create and apply a password to the PDF files generated by a request.
  • The Prevent Form Comments Changes and Prevent Content Extracts and Copying settings control the ability to add comments, annotations, and to copy PDF content.

When all three are set to No, users can add comments and annotations and copy PDF content without needing a password.

Dispensation details

Subject PDFs will contain a Visit History section if the Include RTSM Data option is set to Yes. Keep the following in mind when viewing this information.
  • Kits marked Not Dispensed to Subject are not included in the output.
  • Kit instructions are included when a kit is dispensed as part of advanced dispensation. These instructions are displayed to site users as Dosing Instructions during dispensation.
  • Before running your final extract, update your permissions to ensure unblinded pharmacist kit types and kit descriptions for blinded studies are included in the output.

Table 4-1 Here's what's included in the Visit History section

Action Details
Kit Dispensation
  • Date
  • Kit Number
  • Kit Description
  • Kit Status
  • User
Kit Dispensation (Calculation)
  • Date
  • Kit Number
  • Kit Description
  • Kit Status
  • Calculation
  • User
Kit Dispensation (Titration)
  • Date
  • Kit Number
  • Kit Description
  • Kit Status
  • Titration
  • User
Replacement
  • Date
  • Kit Number
  • Kit Description
  • Kit Status
  • Replacement Kit
  • User
Dose Hold
  • Date
  • Kit Description
  • User

Parent topic: Available archive types and reports