Archival PDF

Generate this type of request for mid-study data analysis or to create a final archive of study data. The archive can be made available to auditors, sponsors, sites, and regulatory agencies.

Tip:

You can generate a Test Run first to ensure the PDF output contains the correct data.

Here's what an Archival PDF request includes

• One folder per site, each containing one PDF per subject.
• A Table of Contents (TOC).
• A PDF containing the Request Settings.
• A set of blank forms with active controls for each study version.

  Note:

  Blank forms are included only when the Request Setting Generate Blank Forms is Yes.

Follow the steps below to create an Archival PDF

Start by accessing Oracle InForm CRF Submit.

1. On the My Requests - Processing page, click Create Requests, then select Create New PDF Request.
2. On the Study Information page, update the PDF Request Name (if applicable), enter an optional PDF Request Description, select Archival PDF, and click Next.

   Note:

   The request name defaults to the study name plus the current date and time.
3. Complete the Form Options, then click Next.

   Table 2-3 Archival PDF Form Options

   Option	Details
   Header Text	Enter text up to 90 characters to appear at the top of each page on the PDF. The study name is the default value.
   Page Size	Letter: (default) 8-1/2" by 11" A4: European letter size: 210 x 297 mm
   Blank Form Format	Unique Forms: One of each form in your study. Casebook: (default) All forms, even those that are repeated. Note: For more information, see How can I handle blank forms?
   Headings Language	Specify the language to use for labeling bookmarks, headers, and footers. English is the default language.
   Footer Text	Enter text up to 30 characters to appear in the footer of each PDF page. ***Confidential*** along with page numbers is the default.
   Include Study Name in the Subject PDF File name	Select Yes (default) for the Study Name to appear in the Subject PDF file name. Select No if the study name is not needed.

4. Complete the Request Settings, then click Next.

   Table 2-4 Archival PDF Request Settings

   Setting	Details
   Allow PDF request to be stored in eTMF Note: This setting is only available when the trial setting Enable eTMF Download is enabled.	For more information about this setting, see About Electronic Trial Master File (eTMF).
   Share with Sites Note: Appears only if you belong to a rights group with the Share Archives with Sites right.	Select Yes (default) if you want to make the PDFs made available for download by site users. Select No if site users do not need to download this request.
   Site Confirmation Required Note: Appears only if Share with Sites is Yes.	Select Yes (default) if you want site users to confirm downloading a request shared with them. Note: For more information about the site confirmation process, see Confirm archives and reports. Select No if you do not require confirmation from site users.
   Select the rights group to control content	The rights group selected determines what content gets included in the PDF output. The default is the logged-in user's rights group
   Allow any Site User to download this request Note: Appears only if Share with Sites is Yes.	Select Yes to allow any site user with Archives access to download the request. Select No (default) to allow only site users assigned to the rights group selected for Select the Rights Group to Control Content to download the request.
   Notify CRFS Site Users Note: Appears only if Share with Sites is Yes.	Select Yes to send site users the, PDF or History Request is available for download (Site user, when share with sites) notification when a request is available for download. Note: The notification is only sent if it has been enabled. For more information, see About email notifications. The setting displays even if the notification is not enabled. Select No (default) if the notification should not be sent.
   Audit Location	Select After Each Form to place audit trail data at the end of each form. Select End of PDF (default) to place it at the end of the PDF.
   Include data as of date and time	Select Now (default) to include all data available up to the date and time displayed. Select Select date/time to enter a specific date. Note: The date cannot be before the first subject’s study enrollment date. For more information, see How does the Include data as of date and time option affect the output?.
   Export Selection Criteria	Select to create PDFs for All Subjects (default) By Site For more information, see How do I define the Export Selection Criteria?, and How do I enter a large number of subjects?
   Candidate Queries	Select Yes (default) to include Candidate Queries in PDFs. Select No to exclude them.
   Generate Blank Forms	Select Yes (default) to include blank forms. Select No to exclude them.
   Prevent Form Changes	Not editable for this request type, displayed for information purposes only.
   Prevent Form Comments Changes	Select Yes (default) to prevent comments and annotations from being added to the output PDF. Select No to allow comments or annotations.
   Prevent Content Extracts and Copying	Select Yes (default) to prevent content being copied from the output PDF. Select No to allow content to be copied.

5. Review the request settings displayed on the Review and Submit page for accuracy.
   • Click Save to save the request to the Saved tab under My Requests. You can access this request later to make edits and generate it.
   • Click Print to print a copy of the request settings. The zip file also includes a copy of the request settings.
   • Click Submit to generate the request.
6. The PDF Request Submitted window opens and presents the following options.
   • Click Yes, Create Another to return to the Create New PDF Request page.
   • Click No, Go to Processing Page to be taken to the My Requests - Processing page.
7. On the My Requests - Processing page, click Refresh until the % Complete column displays 100.

   Note:

   Completed requests are moved to the My Requests - Completed page.
8. You can now Download the PDF.