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.

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

Filters

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. Choose Select Date/Time to enter a specific date. Note: The date entered 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. Choose Select Subjects to include data for a selection of enrolled subjects in the request output. Note: If a subject number was changed, the As of Date determines what value is presented in the drop-down. Choose Select Sites to include data for a selection of sites and their subjects 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 side panel, 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 - Include RTSM data	Select Yes to include subject RTSM data elements in site-level archives. Select No (default) to exclude subject RTSM data. For more information, see When an Archives request includes RTSM data below.
Advanced settings - PDF security	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 Context 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.

When an Archives request includes RTSM data

The following Randomization and Dispensation details are included in subject PDFs when the setting Include RTSM Data is set to Yes. This advanced setting is available for Submission, Archival (Site and Sponsor), and Custom archive requests.

Randomization details

Subject PDFs include a Subject History section, which refers exclusively to Randomization events.

Note:

This section is unrelated to the Subject History right-side panel in the user interface, which includes details for events like screened and withdrawn, which are not included in the Subject History section of subject PDFs.

Table 4-3 The Subject History section in subject PDFs includes:

Action	Details
Randomized	Randomization Date Randomization Number

Dispensation details

Subject PDFs also include a Visit History section when Include RTSM Data is set to Yes.

Table 4-4 The Visit History section in subject PDFs includes:

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

Additional information

• Kits marked Not Dispensed to Subject are not included in the output.
• 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.