Custom PDF

This archive type gives users assigned to a sponsor study role access to all of the settings available in Oracle CRF Submit, letting them control what to include in the output.

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 archive output ZIP file contains the following:

  • A folder for each site containing PDFs for each subject. Subject transfer history files (.prth files) are also included for transferred subjects.
  • A set of blank PDFs containing active controls for each study version selected.
  • 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.
Share with Sites
  • Select Yes if you want the PDFs made available for download by site users.
  • Select No (default) if site users do not need to download the request.

Confirm Site Downloads

Only available if Share with site is set to Yes.

  • Select Yes (default) if you want site users to confirm downloading the archives shared with them.
  • Select No if you do not require confirmation from site users.

Included in Report

The Select Subjects option is only available if Share with sites is set to No.

  • 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
Include Blank Forms
  • Select Yes to include blank forms in the PDF output.
  • Select No (default) if blank forms are not needed.

Blank Form Format

 Only available if Include Blank Forms is set to Yes.
  • Select Casebook (default) to show all forms in every visit.
  • Select Unique Forms to show one of each blank form in every visit.

Study Versions

Only available if Include Blank Forms is set to Yes.

  • Select All Versions (default) to include blank forms with active controls for all study versions.
  • Choose Select Versions to include blank forms with active controls for specific study versions.

    The study versions displayed are based on the mode you're working in. All study versions are available for selection in Testing Mode, and approved and archived study versions are available in Production.

    Note: Archived versions are those that were approved and then archived. Study versions that were moved from Draft and Testing directly to Archived are not included in Production.

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 section Details
Display in Archive Header
Select Yes for any of the following to display them in the header of each page of the PDF.
  • Form Version
  • Visit Name and Number
  • Site Name and Number
  • Sponsor Name
  • Protocol Name
Data Inclusion and Format
  • Include Study Name in the Subject File Name: Select Yes (default) or No.
  • Transferred Subjects in Current Site Only: Select Yes to include only data from a transferred subject's current site. Select No (default) to include data from both the source and the destination sites for a transferred subject.
  • Forms to Include and Visits to Include

    Enable the Select Forms option to choose specific forms for inclusion in the output, or enable the Select Visits option to include all forms from the selected visits.

    Note: For additional information about these settings, see the Forms to Include and Visits to Include details section below.

  • For Include RTSM Data and Include Subject Event Data see the next row for details.
  • Include Uploaded Files: Some form questions allow users to upload documents, such as images. By default, these documents are included in the request output. If you prefer not to have them included, change the setting to No. For more information, see About the Advanced Setting—Include Uploaded Files.
  • Include Bookmark Prefixes: Select Yes or No (default)
  • Audit Trail Location: Select After each form (default) or End of PDF.
  • Generate TOC (table of contents): select Yes (default) or No
Data Inclusion and Format
  • 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.

Security settings

  • Prevent Form Changes: Select Yes to require a password to make changes to the PDF. No is the default.

    Note: When Yes is selected, the Password and Confirm Password fields dynamically appear. Passwords entered are not saved and cannot be retrieved by Oracle.

  • Prevent Form Comment Changes: Defaults to No. Select Yes to prevent comments and annotations from being added to the output PDF without the password.

    Note: The option is only active if Prevent Form Changes is Yes.

  • Prevent Content Extracts and Copying: Defaults to No. Select Yes to prevent contents being copied from the output PDF without the password.

    Note: This option is only active if Prevent Form Changes is Yes.
eTMF Allow archives to be stored in Oracle sFTP
  • Select Yes to send an archive to the Oracle sFTP server. Requests can then be programatically transferred to an eTMF system.
  • Select No (default) if you do not need to send an archive to the Oracle sFTP server.

Before enabling this setting, see About eTMF .

Forms to Include and Visits to Include details

The details below pertain to the Forms to Include and Visits to Include settings.

  • Enabling one of the settings renders the other unusable.
  • Form options are shown as Form Name (Reference Code), while visit options appear as Branch Name (Visit Name). If no branch exists, only the Visit Name is displayed.

    Note:

    To include the Date of Visit form in the output, select Visit Date from the Select Forms drop-down.
  • The options under each setting are determined by the mode you're working in and the As of Date option you select.
    Setting Details
    Mode When you generate a Custom PDF archive in either Testing or Production mode, the options presented under each drop-down are based on the latest study version associated with your site for that specific mode.
    As of Date
    The latest study version is determined by the option you select.
    • When set to Now, the list of forms and visits corresponds to the most recent study version associated with your site.
    • When you select a specific date (using Select Date/Time), the list of forms and visits is based on the latest study version that was associated with your site on or before the date specified.

      For example, you are working in Testing mode and enter the As of Date of 04-June-2024. At that time, study version 1.0.0.12 was the last version associated with your testing site. In that case, the drop-downs display the forms and visits from study version 1.0.0.12.
  • If no data is present for a selected form, the subject PDF contains the following message.

    There is no data present for this subject because either the subject add was undone or no data was found for the selection criteria in Request Settings.

    Note:

    All forms associated with a study version are available. If you select a form that you do not have access to in the study, for example, due to data classification, the PDF for that form is blank, and the above message is displayed.

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 4-4 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