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

Click Module 13 followed by Begin to begin this module.

Click Send ID 99006 to email a copy of ID99006_diary.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

	Note
	Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files. Wait 2-3 minutes prior to proceeding to DFexplore.

Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore”.

Select View > List.

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

Click OK to close the dialog.

In the main List View window, Plates & Metadata panel, click 011 - Weekly Patient Diary in the list of plates.

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
	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.

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

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 setup 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.

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.

In the record list panel, 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.

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

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

Click ... next to Output File. Choose a directory in the file selection dialog, enter module13_dates.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

Using the computer's file explorer, locate the file module13_dates.xlsx. Open the file, confirm the contents and then close the file.

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

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
	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.

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

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

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.

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

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

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.

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.

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

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

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

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

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.

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

Click Find Next to locate the next match.

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

Select File > DFsas. The DFsas dialog opens.

	Note
	If you have previously executed this module as valid1, 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.

Click Add to create a new DFsas job.

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

	Note
	The RUNDIR directory was specified as C:\Users\valid1\Desktop in this example. Given the directory structure on your local computer, you may have chosen a different value for RUNDIR.

Click PLATES ... to view all defined study plates. From the list, hold Control key (hold 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.

In the Optional panel set:

Click OK to create and add jobfile1.

Click OK in the summary confirmation dialog.

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.

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

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

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

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.

Using the operating system 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.

With a text editor application, 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 13.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

With the same text editor application, 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 13.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

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

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.

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.

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

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.

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

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.

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

Select File > Exit to close DFexplore