Chapter 15. Module 15. Data Export and DFsas

Table of Contents

15.1. Tests & Requirements
15.2. Begin Module 15. Data Export and DFsas.
15.3. Export date values in calender format and save the exported data to a file on the local computer.
15.4. Export date values from the database and save the exported data to a file on the local computer.
15.5. Examining data values according to user-specified criteria.
15.6. Query the database for specific data values.
15.7. Create a DFsas job file according to user-specified criteria.
15.8. Create a SAS job file and data files using the DFsas job file criteria.
15.9. Compare the contents of SAS data files with the actual data in the database.
15.10. End Module 15. Data Export and DFsas.

15.1. Tests & Requirements

  1. Export date values in calender format and save the exported data to a file on the local computer.

  2. Export date values from the database and save the exported data to a file on the local computer.

  3. Examining data values according to user-specified criteria.

  4. Query the database for specific data values.

  5. Create a DFsas job file according to user-specified criteria.

  6. Create a SAS job file and data files using the DFsas job file criteria.

  7. Compare the contents of SAS data files with the actual data in the database.

Estimate of Time Required: 30 Minutes

15.2. Begin Module 15. Data Export and DFsas.

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

  2. Click 15. Data Export and DFsas followed by Begin to begin this module.

  3. Click Send ID 99006 to email a copy of ID99006_diary.pdf to data_manager. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for data_manager to receive the module specific PDF files.

    Wait 2-3 minutes prior to proceeding to DFexplore.

15.3. Export date values in calender format and save the exported data to a file on the local computer.

All data exported in the following tests will be output to the DFexplore List View screen rather than saved to a file. List View does have 3 save options: Export Data, Save Data Retrieval File and Save As PDF.

  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 View > List.

  3. Select File > Preferences. In the dialog, locate the List View panel. Click and enter the List View settings as follows:

    • Display field name as = alias

    • Display coded field as = label

    • Display date field as = calendar

    • Check (enable) apply imputation rule

    • Display missed code as = default

    • Check (enable) Fill cell with field color

    • Uncheck (disable) Expand text fields

  4. Click OK to close the dialog.

  5. In the main List View window, Plates & Metadata panel, click 011 - Weekly Patient Diary.

  6. Select Select > Field Selection to show the listing of all data fields and their metadata properties defined for the plate. In the Data Fields window, click next to fields 7:SUBJID011,10:DDATE1,16:DDATE2,22:DDATE3,28:DDATE4,34:DDATE5,40:DDATE6 and 46:DDATE7. The fields are added to the Display Fields window.

    [Note]Note

    Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  7. Click Done to apply the field selection criteria and close the dialog.

  8. Examine each of the exported date fields. Locate the field column for DDATE1 in the table. This is field 10, 1. Date on the WEEKLY PATIENT DIARY page. In Section 3.12, “Submit a copy of the newly defined Plate 11 into the study database and retrieve the page in DFexplore Image View.” this field was defined with the format dd/mm/yy (a 2-digit year). Verify that field 10 has been correctly exported in calendar (4-digit year) format.

  9. Double-click DDATE1 cell for ID 99006 in the table. This takes you to the corresponding date field in the WEEKLY PATIENT DIARY page in Data View. Confirm that the date values are the same as those on the printed WEEKLY PATIENT DIARY for Subject 99006.

  10. In the record list, click Return to List View to be taken back to the date fields in List View. Confirm that the date values displayed are the same as those on the printed WEEKLY PATIENT DIARY, except now in calendar (4-digit year) format.

15.4. Export date values from the database and save the exported data to a file on the local computer.

  1. Select File > Preferences. In the List View panel, choose julian as the value of Display date field as. Click OK to apply the settings and close the dialog. Confirm that the exported date values are now in julian format.

  2. Select File > Export Data to save the dates to a local file. In the dialog, set:

    • Format = Excel

    • Check (enable) Include header as the first record in output file

    • Check (enable) Open output file after export

  3. Click ... next to Output File. Choose a directory in the file selection dialog, enter module15_dates.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

  4. The file module15_dates.xlsx opens. Confirm the contents and then close the file.

15.5. Examining data values according to user-specified criteria.

  1. From the list of plates, select plate 001 - Blood Pressure Screening Visits to make it current.

  2. Select Select > Field Selection. In the Data Fields window, click next to fields 7:SUBJID001,8:PINIT001,9:AGE,10:SEX. The fields are added to the Display Fields window.

    [Note]Note

    Fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  3. Click Done to apply the field selection criteria and close the dialog. Examine each of the data fields.

  4. To search for specific subject data, select Select > Search. Enter 99003 in the Subject field.

  5. Click Find to start the search. Examine the message in the bottom-left corner of the dialog as well as the highlighted entry in the List View table.

  6. Click Find Next to locate a 2nd match (if one exists) in the List View table.

  7. Click New Task to create a task set of records that match the search criteria. In the resulting dialog, change the Mode to View.

  8. Click Yes in the Data List dialog to create the task set. Examine the message in the bottom-left corner of the Search dialog, then click Done to close the dialog.

  9. Click Switch to Data View to open Data View and review the List View task record. Examine the Data View record list and confirm that only the task record for Subject 99003 is displayed. Click Return to List View.

15.6. Query the database for specific data values.

  1. Select File > Preferences. In the dialog, locate the List View panel. Choose default for Display date field as. Click OK to save the setting and close the dialog.

  2. Click 007 - Study Termination to make it the current page. Select Select > Search to open the Search dialog.

  3. Click Reset and Reset in the resulting dialogs to clear all previously specified search criteria.

  4. Click ... next to the Expression field. The Expression Editor opens.

  5. For the first part of the query, select 9:FINALDAT from the Fields table. Next, click >= in the Symbols list. Choose julian from the Functions list. In the Expression field, enter the date "1997/01/01" (including the quotes). Close the parentheses. To build the second part of the query, click && From the Symbols list, followed by field 9:FINALDAT from the Fields table. Next, click <= in the Symbols list. Choose julian from the Functions list. In the Expression field, enter the date "1997/06/30" (including the quotes). Close the parentheses. Click OK.

  6. Click Find to locate all subjects that have study termination dates that match the specified search expression.

  7. Click Find Next to locate the next match.

  8. Do not continue the search and click Done to close the Search dialog.

15.7. Create a DFsas job file according to user-specified criteria.

  1. Select File > DFsas. The DFsas dialog opens.

    [Note]Note

    If you have previously executed this module as data_manager, the DFsas Jobs panel may display jobfile1 and possibly other files. If jobfile1 is already in the list, highlight jobfile1 and click Delete before continuing with this module.

  2. Click Add to create a new DFsas job.

  3. Enter SASJOB = jobfile1. Click RUNDIR ... to display the file selection dialog. Choose a directory to save "jobfile1" and click Open.

    [Note]Note

    The RUNDIR directory was specified as C:\Users\Public\ in this example. Given the directory structure on your local computer, you may have chosen a different value for RUNDIR.

  4. Click PLATES ... to view all defined study plates. From the list, hold Control key (Command on macOS) and click the entries for 002 - Patient Entry Form and 009 - Adverse Event Report to highlight them. Click OK. Choose FIELDS = include all.

  5. In the Optional panel set:

    • Check (enable) only calendar for Date Formats

    • String Size = as is

    • Field = use alias

    Click OK to create and add jobfile1.

  6. Click OK in the summary confirmation dialog.

  7. Edit the SUBJECTS global specification in the new jobfile1 by selecting it from DFsas Jobs panel. In the main window, change the text SUBJECTS all to SUBJECTS 99001,99002. This will limit the created SAS data files to subjects 99001 and 99002 only.

  8. Locate the global specifications for CHECK and CHOICE. Change CHECK codes to CHECK labels and CHOICE codes to CHOICE labels.

  9. Click Save to save the changes. In the resulting confirmation dialog, choose replace existing job and click OK.

15.8. Create a SAS job file and data files using the DFsas job file criteria.

  1. In the DFsas window, highlight jobfile1. Click Run to create SAS job and data files.

  2. In the confirmation dialog, do not check Force DFsas to include all specified plates. The SAS job and data files will not include empty plates. Click Yes to continue and run the DFsas job. After a pause while the job runs, the results dialog appears. Click OK to close the dialog.

  3. Using the file explorer, locate the directory previously specified as the value of RUNDIR. Confirm that jobfile1.zip is present. Double-click jobfile1.zip to unzip the file. Open the jobfile1 folder and confirm that the files jobfile1, jobfile1.sas, jobfile1.d01 and jobfile1.d02 are present.

  4. With a text editor, open the data file jobfile1.d01. Examine the contents and confirm that it contains 2 data records - one for each of subjects 99001 and 99002. Print the file (you will need to reference this printed output in Section 15.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

  5. With the same text editor, open the data file jobfile1.d02. Examine the contents and confirm that it contains 1 data record. Print the file (you will need to reference this printed output in Section 15.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

15.9. Compare the contents of SAS data files with the actual data in the database.

  1. Click Cancel to dismiss the DFsas dialog. Select Select > All Records. Without changing any settings, click OK.

  2. Select View > Data to change from List View to Data View. In the record list, double-click icon for the open Subject 99003 to close the subject binder. The list now displays all subjects for Site 99 - Hospital #99.

  3. Double-click Subject 99001. Select Subject > Expand All Visits. Locate the entry for 2: Form 2 within the 1 : Baseline visit and select it from the list to open the data record.

  4. Compare the values in each field of the data record with those values in the printout of the data file jobfile1.d01.

  5. Double-click Subject 99002 from the record list. Select Subject > Expand All Visits. Locate the entry for 2: Form 2 within the 1 : Baseline visit and select it from the list to open the data record.

  6. Beginning with Subject 99002, Baseline, Form 2, compare the values in each field of the data record with those values in the printout of the data file jobfile1.d01.

  7. Double-click Subject 99001 to re-open the subject binder. Select Subject > Expand All Visits. Locate the entry for 9: form 9, AE Report 011 within the 1011: Adverse Event 1 Page 1 visit and select it from the list to open the data record.

  8. Compare the values in each field of the data record in DFexplore with those values in the printout of the data file jobfile1.d02.

  9. Select File > Exit to close DFexplore.

15.10. End Module 15. Data Export and DFsas.

  • Return to the DFATK application. Click End to confirm successful completion of Module 15. Data Export and DFsas.