Custom PDF

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;
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.
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 Note: Only displayed if Share with sites is Yes.	Select Yes (default) if you want site users to confirm downloading the archives shared with them. SelectNo if you do not require confirmation from site users.
Included in Report Note: The Select Subjects option is only displayed if Share with Sites is No.	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
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 Note: Only displayed if Include Blank Forms is 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 Note: Only displayed if Include Blank Forms is Yes.	Select All Versions (default) to include blank forms from all study versions. Choose Select Versions to include blank forms from specific study versions.
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 - Display in Archive Header	Select the items to appear at the top of every page in the PDF file. Form Version: Select Yes (default) or No Visit Name and Number: Select Yes (default) or No Site Name and Number: Select Yes (default) or No Sponsor Name: Select Yes or No (default) Protocol Name: Select Yes or No (default)
Advanced Settings - Data Inclusion and Format	Include Study Name in the Subject File Name: Select Yes (default) or No Forms to Include: All forms are included by default Visits to Include: All visits are included by default Include RTSM Data: Select Yes to include randomization and dispensing information for subjects at your sites. For additional details about this setting, see When an Archives request includes RTSM data below. The default is No. 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
Advanced Settings - Security	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.
Advanced Settings - 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 .

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 4-9 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 4-10 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.