Instructions
The PDF Export/Closeout report allows the selection of site(s) that contain subjects you would like to include in a PDF export. Useful in study closeout out when you want PDF the subject records for the master file.
This application can be turned on in Study Configuration>Role Security Tab. The application to choose is "Study Configuration". Grant access to study configuration by checking the box.
To Run the report:
Click on Reports drop-down choice (below)
Select the CRF Export/Study Closeout Report
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Step 1 - Select Sites (below)
Check Sites to include in report
Click Next Button
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The second step is to select the subjects you want to export to PDF. (below)
The following is a Tree View control. To expand a site and display that site's subjects, click the "+" before the site. To select a subject, check the corresponding box. To Select all subjects for a given site, check the box prior to the Site Name.
Click Previous to return to "Step 1 - Select Sites" or Next to go to step 3.
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The third step allows you to filter the forms to be exported to PDF, by status and review level. Any status or review level at or above what you select will be included in the PDF export.
Select minimum form status and minimum review status
Click Previous to return to "Step 1 - Select Sites" or Next to go to step 3.
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The fourth step allows you to define the data you wish to include in the PDF file.
Select the data to include in the PDF file.
Click Previous to return to "Step 1 - Select Sites" or Next to go to step 3.
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The fifth step allows you to choose title pages to be included in the PDF document. A title page is a page dedicated to showing the beginning a new section of information.
Select Title Pages to include in the report.
Click Previous to return to "Step 1 - Select Sites" or Next to go to step 3.
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The final step is to click the Finish button and produce the document. Some documents can be thousands of pages depending on the size of your study. Please be patient with the process.
Click Previous to return to "Step 1 - Select Sites" or Next to go to step 3.
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Click the Export to PDF Button to Begin the Process.
When complete, a downloaded ZIP file will contain the PDF documents. Save to destination of choice.
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batch PDF export tool allows for exporting bookmarked casebooks, complete with navigational linking along with audit trail and query information. It is similar to exporting PDFs from the subject manager, but with the added capability of doing so for a group of subjects at a given site
This is useful for submissions or having the paper version of a casebook for a master file.
Permissions needed to access and execute the activities covered in this article:
Access to Batch PDF Exports
Study Events Report
Site membership is enforced, so the user accessing it can only export PDFs for their own site(s).
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Field blinding is enforced - so be sure to consider which role is doing the exporting because some data may not be shown if fields are blinded to that role. On a related note, form view permissions are NOT enforced from the CRF export tool. It should be expected that anyone with access to this tool is able to view all forms being collected at the subject level. |
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Using the CRF Export Tool
To access this tool, select the CRF Export tool under the Data Extraction menu:
Select which site to export the subject casebooks for. Due to the potential size of the export, the system limits to a single site at a time.
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Next, select which subjects to include. To include all subjects, simply check the site:
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Select the status of records to filter the exported file on. As an option, unscheduled records (log forms and unscheduled visits) can be excluded:
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Select the information to include in the export:
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The final screen will present a button to tap to initiate the export. The export will run in the background so you can return later to retrieve the file.
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If data volume for the study is high on a per-subject basis, please consider this when having the system build a package for multiple subjects. On a large volume study it's recommended to try first with one subject to get an idea of how long the process takes per subject. |
File Format and Content
Files are downloaded as Zipped folders where each subject is a separate file of all its corresponding records.
Similar to the PDF exports from the subject manager, each file will have an index for easy navigation and headers to display the details of each page.
An added benefit of links to the audit and query details is found at the top of each form. Use the links to quickly jump to those pages, and then the index on the left to jump back to the form.
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Be aware that data on the exported files will enforce role-based form view permissions and field blinding for the user who is performing the export. |
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