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.
- 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
- Confirm download of Archival PDFs and content
- Download Archival PDFs, and Audit Reports
- Run Archival PDFs for your site(s)
Setting | Details |
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Name | Enter a unique name (alphanumeric characters only) that does not exceed 64 characters. |
As of Date |
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Included in Report |
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Page Size |
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Include Blank Forms |
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Blank Form Format Note: Only displayed if Include Blank Forms is set to Yes. |
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Header Text |
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Footer Text |
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Advanced Settings - Include RTSM data |
For more information, see When an Archives request includes RTSM data below. |
Advanced Settings - Allow archives to be stored in Oracle sFTP |
Before enabling this setting, see About eTMF . |
Advanced Settings - PDF security |
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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 contain a Subject Randomization History section, which includes details related to randomization events.
Table 4-8 The Subject Randomization History section in subject PDFs includes:
Action | Details |
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Randomized |
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Dispensation details
Subject PDFs also include a Visit History section when Include RTSM Data is set to Yes.
Table 4-9 The Visit History section in subject PDFs includes:
Action | Details |
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Kit Dispensation |
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Kit Dispensation (Calculation) |
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Kit Dispensation (Titration) |
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Replacement |
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Dose Hold |
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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.
Parent topic: Available archive types and reports