- User Guide for Site Users
- Create an archive or report
- Create an archive of study data
Create an archive of study data
Site users with the Generate Archives right can generate a PDF archive of study data.
- Click Archives in the top navigation bar.The Site Archives page opens, your site is displayed by default. You are presented with a drop-down if you are associated with multiple sites.
- On the Requests tab click Create Requests then select Site Request.The Create New PDF Request - Study Information page opens.
- Complete PDF Request Name, PDF Request Description, and confirm the correct site is selected for Select the site for the request.Details about each field can be found in the following table.
Table 2-1 Study Information field details
Field Details PDF Request Name The default value is the study name plus the current date/time. Rename if applicable. PDF Request Description Optional Select the site for the request The default is your site if you belong to only one. If you belong to more than one it displays the site selected on the Site Archives page. - Click Next.The Create New PDF Request - Form Options page opens.
- Complete the Form Options fields.Details about each field can be found in the following table.
Table 2-2 Form Options field details
Field Details Header Text The default value is the study name. You can enter up to 90 characters to appear at the top of each PDF page. Page Size Select Letter (default) or A4 for the page size of your PDF archive. Blank Form Format Select Unique Forms to show one of each blank form in every visit. Select Casebook (default) to show all forms in every visit. For more details, see How can I handle blank forms? Headings Language To display bookmarks, headers, and labels in Japanese, select Japanese from the Headings Language drop-down. The default is English. Include Study Name in the Subject PDF File Name Select Yes (default) for the Study Name to appear in the Subject PDF file name. - Click Next.The Create New PDF Request - Request Settings page opens.
- Define your Request Settings filters.Details about each filter can be found in the following table.
Table 2-3 Request Settings filter details
Filter Details Include data as of date and time Select Now (default) or Select date/time. The output includes all available information up to now or the date and time entered. For more details, see How does the Include data as of date and time option affect the output? Export Selection Criteria (Up to 50000 subjects can be selected) Note:
The sponsor-controlled trial setting, Maximum Subjects per PDF Request by site user, controls the number of subjects that can be selected. For more information, see Specify trial settings.Select All Subjects or By Subject. If By Subject is selected a window opens allowing you to choose specific subjects. Hold Ctrl to select multiple subjects, then use the arrows to move them.
If you need to edit the list click By Subject again to reopen the window.Note:
Only subjects enrolled prior to the as-of date appear in the By Subject list.Generate Blank Forms Select Yes (default) to include blank forms (without clinical data) in the output. Prevent Form Comments Changes Select Yes to prevent comments from being added to the output PDF, select No (default) to allow comments or annotations to be added to the PDF. Prevent Content Extracts and Copying Select Yes to prevent contents being copied from the output PDF, select No (default) to allow text to be copied. - Click Next.The Create New PDF Request - Review and Submit page opens.
- Review your request settings and click View Selected Subjects to confirm the request includes the correct details.
- Click Submit.
- Click Yes, Create another or No, Go to Site Archives.If Yes, Create another is selected you are taken to the Create New PDF Request page. If No, Go to Site Archives is selected you are taken to the Site Archives page.
- On the Site Archives page click Refresh until the Download link is made available.For more information, see Download archives and reports .
Parent topic: Create an archive or report