Archival PDF (for sponsor users)
Users assigned to a sponsor 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. 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.
Note:
The archive does not contain any associations between repeating forms assigned to different visits or form types, or associations between a repeating form and a standard form.Modes
Available only in Testing and Production mode. To get started, Access the Reports & Archives page.
Required permissions
- Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Filters
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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Share with Sites |
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Confirm Site Downloads Note: Only displayed if Share with Sites is Yes. |
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Included in Report Note: The Select Subjects option is only displayed if Share with Sites is No. |
|
Page Size |
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Include Blank Forms |
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Blank Form Format Note: Only displayed if Include Blank Forms is 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 4-6 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 4-7 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