Archival PDF (for site users)

Users assigned to a site study role typically use this archive type for mid-study data analysis or to generate a final archive of study data. This makes the data available for auditors, sponsors, sites, and regulatory agencies.

Subject data in the output files match the data the user generating the archive can see in the user interface.

The archive 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 site study role that includes the following permissions can generate this archive.

• Confirm download of Archival PDFs and content
• Download Archival PDFs, and Audit Reports
• Run Archival PDFs for your site(s)

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
Include Blank Forms	Select Yes (default) to include blank forms in the PDF output. Select No if blank forms are not needed.
Blank Form Format Note: Only displayed 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.
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 - 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 if you do not need to send an archive to the Oracle sFTP server. Before enabling this setting, see About eTMF .
Advanced Settings - PDF security	The Prevent Form Changes setting controls the ability to create and apply a password to the PDF files generated by a request. Note: The setting defaults to Yes for this request type, and a password is created but cannot be retrieved. The Prevent Form Comments Changes and Prevent Content Extracts and Copying settings, which default to No, control the ability to add comments and annotations and to copy PDF content. Change to Yes if you'd like to prevent users from adding comments and annotations and copying PDF content.

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 4-7 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 4-8 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.