The Archival PDF request type is most suitable for PDFs that will represent study contents for archival purposes. Blank forms are also generated by default.
Use this request type to create a mid-trial archive or final archive and share the archive with one or more sites. The sites can download their PDFs, examine them, and confirm that they have downloaded and reviewed the PDFs.
Archival PDF request settings
Setting |
Choices |
Notes |
---|---|---|
Enable eTMF integration |
Yes or No |
Makes the PDF output available where someone with the eTMF right can access it. Appears only if eTMF integration has been enabled on the Settings page. For more information, see Specifying trial, email, and storage settings. |
Share with sites
|
Yes or No |
No is the default. Select Yes to allow sites to download the archival PDF files. Sponsor users without the Share with Sites right will not see this option. |
Site Confirmation Required |
Yes or No |
This field appears if you select Share with sites. If these PDFs are meant for final archival, or MHRA submittal, select Yes to require sites to confirm download of this request. Select No to make confirmation optional. |
Export Selection Criteria |
All Subjects By Subject By Site |
The default is All Subjects. This choice includes everything in the study. To select subjects from one or more sites, select By Subject. This option does not appear if you select the Share with sites option. You can select subjects from multiple sites and bulk load subjects from a file. If you select By Subject, the Select Subjects dialog box appears.
If you select By Site, the Select Sites dialog box appears.
|
Generate Blank Forms |
Yes or No
|
Select Yes, the default value, to include blank forms (without clinical data). |
Require Password to Change Document Require Password to Change Form Comments Require Password to Extract or Copy Contents |
Yes or No |
Password protection is selected by default.
|
Require Password to extract zip file |
Yes or No |
By default, password protection is not selected. To include password protection:
|
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