Chapter 16. Module 16. PDF File Creation

Table of Contents

16.1. Tests & Requirements
16.2. Begin Module 16. PDF File Creation.
16.3. Retrieve existing data according to user-specified criteria.
16.4. Saving DFexplore data to a standard PDF document.
16.5. Viewing a standard PDF data file using a PDF viewer application.
16.6. Saving DFexplore data to an encrypted bookmarked PDF file.
16.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.
16.8. Create a complete subject package PDF file that includes data records, CRF images and audit trail.
16.9. Open and view a PDF subject package using a PDF viewer application.
16.10. End Module 16. PDF File Creation.

16.1. Tests & Requirements

  1. Retrieve existing data according to user-specified criteria.

  2. Saving DFexplore data to a standard PDF document.

  3. Viewing a standard PDF data file using a PDF viewer application.

  4. Saving DFexplore data to an encrypted bookmarked PDF file.

  5. Open and view an encrypted bookmarked PDF file using a PDF viewer application.

  6. Create a complete subject package PDF file that includes data records, CRF images and audit trail.

  7. Open and view a PDF subject package using a PDF viewer application.

Estimate of Time Required: 30 Minutes

16.2. Begin Module 16. PDF File Creation.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click 16. PDF File Creation followed by Begin to begin this module.

16.3. Retrieve existing data according to user-specified criteria.

  1. Start DFexplore, login as user data_manager and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. Select Select > By Data Fields. Set retrieval criteria as follows:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Search = Data

    • Subject = 99001,99002

    • Level = 1-4

  3. Click Build Set to retrieve all data records that match the specified criteria. Click OK in the confirmation dialog, and finally click Done to create a task set of the retrieved data.

  4. Scroll the record list panel to confirm that 2 subjects, 99001 and 99002, have been retrieved. Double-click the entry for Subject 99002 to open and lock all records for the subject.

16.4. Saving DFexplore data to a standard PDF document.

  1. Select File > Save as PDF.

  2. In the Selection Criteria panel,

    • Select (enable) Data and images followed by current task set

    In the Save Options panel,

    • Check (enable) Data records and data + primary image (side by side)

    • Check (enable) Apply field color for completed plates

  3. Click Output File .... In the file selection dialog, choose a directory in which to save the PDF file.

    Once a directory has been chosen, append the file name subjects.pdf to the directory name. Click Save.

  4. Complete the specification by clicking Save. There will be a busy pause while the PDF file of completed data pages and their primary images is created.

    [Note]Note

    The save directory in this test was chosen to be C:\Users\Public. Your save directory may be different.

16.5. Viewing a standard PDF data file using a PDF viewer application.

  1. A PDF viewer application, such as Acrobat Reader, is required for this step. Start the PDF viewer application. Locate the directory in which the PDF file subjects.pdf was saved in Section 16.4, “Saving DFexplore data to a standard PDF document.”. Open subjects.pdf.

    [Note]Note

    All PDF files opened in this test and in the remainder of this module are illustrated using Acrobat Reader. If you are using a different PDF viewer application, the appearance of your document may differ from that shown here. It may also be necessary to rotate the PDF image so that it is displayed in landscape format.

  2. Examine the PDF document.

  3. Exit the PDF viewer application.

16.6. Saving DFexplore data to an encrypted bookmarked PDF file.

  1. With the task set of records from Section 16.3, “Retrieve existing data according to user-specified criteria.” (Subjects 99001 and 99002) still the current set, click the record for Subject 99002, Form 1 to set it as the current page. Select File > Save As Bookmarked PDF to open the dialog.

  2. In the Selection Criteria panel,

    • Select (enable) Current subject

    In the Resources panel,

    • Enter a Title of Bookmarked Subject 99002

    • Use the default Nesting plates within visits

    In the PDF Options panel,

    • Check (enable) Data records

    • Check (enable) Missed records

    • Check (enable) Images and select (enable) primary only

    • Check (enable) Apply field color for data records

    In the PDF Output panel,

    • Select an Output File directory using the file selection dialog and set the file name to subject99002.pdf.

  3. Enter module16 as the value for Password.

  4. Click Save to create a password encrypted PDF file of completed data pages and primary images for Subject 99002.

  5. Click OK to close the dialog.

16.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.

  1. A PDF viewer application is required for this test. Start the PDF viewer application. Locate the directory created in Section 16.6, “Saving DFexplore data to an encrypted bookmarked PDF file.”. Locate and open subject99002.pdf.

  2. In the Password dialog enter module16 as the password. This matches the password that was specified at file creation in Section 16.6, “Saving DFexplore data to an encrypted bookmarked PDF file.”. Once the password has been entered, the PDF file opens.

  3. Open all bookmarks for Subject 99002.

  4. In the bookmark panel, each data record is represented by the suffix (data) to distinguish it from the primary CRF image. Click entry Form 2 (data) to make the Form 2 data record the active page. Click entry Form 2 to make the Form 2 primary CRF image the active page.

  5. Exit the PDF viewer application. In DFexplore, select View > Data. Then, select Select > All Records. This will release the task set of records for Subjects 99001 and 99002. Click OK in the resulting dialog to retain the default settings.

16.8. Create a complete subject package PDF file that includes data records, CRF images and audit trail.

  1. Select File > Create Subject Packages.

  2. In the Subject Selection section, choose Subjects from the drop-down and enter 99001,99002,99003 to create complete subject packages for Subjects 99001, 99002 and 99003.

  3. In the remainder of the dialog specify the following settings:

    • Title = Site 99 Subject Packages

    • Check (enable) Data records

    • Check (enable) Missed records

    • Check (enable) Images

    • Check (enable) primary only

    • Check (enable) Include data and metadata change history

    • Check (enable) Apply field color for data records

  4. Specify a PDF output folder by first clicking Output folder ... to view the directory structure for the local computer. Select a directory in which to save the subject package PDF files.

  5. Specify a file prefix to be prepended to each subject package created. Enter Site99_ in the File prefix field.

  6. Do not encrypt the subject packages to be generated by leaving the Password field empty. Click Start to begin generating a complete subject package for each of the specified subjects 99001, 99002 and 99003.

  7. Verify that the output in the confirmation dialog specifies packages for subjects 99001, 99002 and 99003. Click Start to start package creation.

  8. In the confirmation dialog, click View Log. Review the output. Click OK to close the log.

  9. The main Create Subject Packages dialog is displayed. Click OK to close this dialog.

16.9. Open and view a PDF subject package using a PDF viewer application.

  1. A PDF viewer application is required for this test. Start the PDF viewer program. Locate and open the directory in which the PDF subject packages were saved in Step 7. Locate files Site99_99001.pdf, Site99_99002.pdf and Site99_99003.pdf.

  2. Open the subject package for Site99_99001.pdf.

  3. Open all bookmarks for Subject 99001.

  4. In the record list, each data record is represented by the term (data) to distinguish it from its primary CRF image. Click entry Form 2 (data) to make the Form 2 data record the active page. Click entry Form 2 to make the Form 2 primary CRF image the active page.

  5. In the bookmark list click the entry for Data and Metadata Change History to display the complete audit trail report for Subject 99001.

  6. Exit the PDF viewer application to close both the file Site99_99001.pdf and PDF viewer.

  7. Select File > Exit to close and exit DFexplore.

16.10. End Module 16. PDF File Creation.

  • Return to the DFATK application. Click End to confirm successful completion of Module 16. PDF File Creation.