Custom PDF
This archive type gives users assigned to a sponsor study role access to all of the settings available in Oracle CRF Submit, letting them control what to include in the output.
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
- 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. |
|
Study Versions
Note: Only displayed if Include Blank Forms is Yes. |
|
Header Text |
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Footer Text |
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Advanced Settings - Display in Archive Header | Select the items to appear at the top of every page in the PDF file.
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Advanced Settings - Data Inclusion and Format |
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Advanced Settings - Security |
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Advanced Settings - Allow archives to be stored in Oracle sFTP |
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 contain a Subject Randomization History section, which includes details related to randomization events.
Table 4-10 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 4-11 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