11 Generating CRF Reports

RDC Onsite lets you generate the following types of custom reports:

• Patient Data Reports (PDRs)

• Blank Casebook Reports

A Patient Data Report includes all the CRFs and data entered against one patient. Optionally, you can include discrepancy details and audit history, and choose to include only certain CRFs based on report parameters such as visit date, casebook, and CRF status. RDC Onsite generates a separate report for each patient you specify.

A Blank Casebook Report lets you create hard copies of all the planned CRFs in the casebook you specify. You can generate a generic blank casebook, which includes no CRF header information and no response data. You can also generate a patient-specific blank casebook, which includes header information specific to the selected patient, but does not include response data.

All reports are PDF files. You can use any application that opens PDF files, such as Adobe Reader, to print the report or save a copy of the report to your PC.

You can use these reports for electronic submissions and as a printout for off-line discussion and review. In addition, you can use the reports to track your progress during the clinical study.

This chapter includes the following topics:

• Working with the Reports Page

• Generating a Patient Data Report from the Reports Page

• Alternate Ways to Generate a Patient Data Report

• Generating a Blank Casebook Report

• Searching for Report Jobs

• Monitoring the Status and Progress of Your Report Jobs

• Printing a Report

Working with the Reports Page

To open the Reports page, click the Reports tab.

When you open the Reports page, RDC Onsite displays all the report jobs, if any, that you have submitted for processing. Figure 11-1 shows a sample Reports page.

RDC Onsite lists the reports in a table format of rows and columns. You can search for a specific report by job name. In addition, you can click a column heading to sort the reports by that column. Clicking the column heading again toggles the sort from ascending to descending order. Both searching and sorting can help you find a report that you want to view or print.

From the Reports page, you can:

• Generate a new Patient Data Report

• Generate a Blank Casebook Report for the study or for a single patient

• Search for reports that have already been generated

• Monitor reports currently in progress

• View reports

• Print reports

Tip:

Some reports may require extended time to run. You can continue to work in RDC Onsite while a report generates in the background. You can return to the Reports page at any time to view and print your report.

Figure 11-1 Reports Page

Description of "Figure 11-1 Reports Page"

Generating a Patient Data Report from the Reports Page

A Patient Data Report includes all the CRFs and data entered against a patient. You can generate a Patient Data Report for one or more patients. For each patient that you select, RDC Onsite submits a separate job request and generates a separate report.

Optionally, you can include discrepancy details and an audit history in the report. You can also choose to include only certain CRFs in the report based on parameters such as visit date, casebook, and CRF status.

You can use Patient Data Reports for electronic submissions and as a printout for off-line discussion and review.

Note:

CRFs are included in the Patient Data Report that satisfy the criteria you specify in the Report Parameters. Any CRFs that are hidden based on your user role are excluded.

To generate a Patient Data Report from the Reports page: 

1. Click the Reports tab to open the Reports page.

2. Click New Patient Data Report.

   
   Description of the illustration reports_sum_pdr_p1.gif
   
   

3. Select the report parameters that RDC Onsite uses to generate the Patient Data Report.

   You must select a Study Site, which is a required parameter. The other report parameters are optional. You can use the other parameters to include or exclude information in the Patient Data Report. See Table 11-1 for a description of each report parameter.

4. Select the job parameters for the report.

   1. Select the name of the Report Server.

   2. Enter up to 8 characters for the Job Name Prefix. RDC Onsite automatically uses a unique number as the name of a report job, and then adds your specified prefix to the beginning of the job name. You can use the prefix value to easily search for your reports in the list on the Reports page.

   RDC Onsite displays the Job Id, Job Name, and the Output File Name for your reference.

5. Click Submit Job to continue. RDC Onsite prompts for confirmation that you want to generate the report.

6. Click Yes to generate the Patient Data Reports.

Once you submit your request to generate the Patient Data Report, you can return to the Reports page to monitor the progress of your report job. You can also stop a job in progress or check error details if the report generation failed. See "Monitoring the Status and Progress of Your Report Jobs" for more information.

After RDC Onsite successfully generates the report, you can click the link in the View Report column on the Reports page to open and print your report. See "Printing a Report" for more information.

Table 11-1 Report Parameters

Report Parameter	Description
Study Site	Lists all the sites for the current study to which you have privileges. The current study is as specified on the Home page or the Casebooks page. The Study Site is the only report parameter required. The default value is the first site listed in the study.
Patient	Specifies the patients for which you want to generate a Patient Data Report. RDC Onsite submits a separate job and generates a separate report for each patient you specify. You can select all patients, a range of patients, or a single patient. The default value is All.
CRF Date Range	Specifies whether to limit the CRFs included in the report. You can select to include only those CRFs in a certain date range. In addition, you select whether to define the range by CRF visit date or creation date. The default value is No Limit.
Casebook	Lists all the casebooks for the current study. RDC Onsite uses the selected casebook for CRFs not entered against a particular casebook. The following conditions apply: If not otherwise specified, RDC Onsite uses the patient's casebook. If a patient is not assigned to a casebook, RDC Onsite uses the study's default casebook. If the study has no default casebook, RDC Onsite uses the first active casebook in alphabetical order.
Mark Values	Defines whether to mark values that changed since approval, since verification, or since a specific date. If you select Mark Values along with the Include Audit History option, RDC Onsite uses the marked values as the basis of the audit history. If you do not select Mark Values, and only select the Include Audit History option, RDC Onsite creates a complete audit history for the report.
Include Audit History	Defines whether to include the audit history for each CRF in the report. When selected, the audit history is included in the Ancillary Data pages for each CRF. The report includes an audit history for all fields, even for those fields (responses) that have never been updated. Deleted CRFs, if any, are included in an appendix.
Include Discrepancy Details	Defines whether to include the discrepancy details for each CRF in the report. When selected, the discrepancy details are included in the Ancillary Data pages for each CRF. The report does not include the details for hidden discrepancies (that is, for discrepancies that are hidden from the user submitting the report).
Include CRFs entered in classic data entry	Defines whether to include the CRFs that were entered using RDC Classic or Oracle Clinical. The CRFs are included only if the DCI Form is available.
Date Format	Specifies the format to use for the report dates. You can select US, Standard, European, Swedish, and Dynamic.
Orientation	Defines how RDC Onsite orients pages for printing. You can select Portrait or Landscape. The default value is Portrait. This value affects only the cover page, the ancillary data pages, and the appendix pages of the report. The orientation of a CRF is always defined by its layout regardless of your selection.
CRF Status: Discrepancy	Defines whether to include only CRFs with a particular discrepancy status. You can select All, Active, Other, Open (Active & Other), or Clean (None or Closed). The default value is All. If you select Clean, the report includes CRFs with no discrepancies or with closed discrepancies, as well as CRFs that have only hidden discrepancies. If you select Active, Other, or Open, the report does not include CRFs that have only hidden discrepancies.
CRF Status: Approval	Defines whether to include only CRFs with a particular approval status. You can select All, Not Approved, Approved, Awaiting Re-Approval, and Approval Undone. The default value is All.
CRF Status: Verification	Defines whether to include only CRFs with a particular verification status. You can select All, Not Verified, Verified, Awaiting Re-Verification, and Verification Undone. The default value is All.

Alternate Ways to Generate a Patient Data Report

In addition to the Reports page, you can generate a Patient Data Report from the Home page, the Casebooks page, and the Review CRFs page.

When you generate reports from these other pages, you cannot customize the content of the report because you cannot specify any of the report parameters. (See Table 11-1 for a description of the report parameters.)

When you generate a Patient Data Report from the Home, Casebooks, or Review CRFs pages, the report:

• Does not include discrepancy details and audit history.

• Uses a default job name prefix. You cannot override this value.

• Includes CRFs entered using Oracle Clinical or RDC Classic if the DCI Form is available. (The report includes these CRFs even if the CRFs have not been migrated.)

If you generate a Patient Data Report from the Reports tab, you choose whether the report includes or excludes all the items listed above.

Generating a Patient Data Report from the Home or Casebooks Page

When you generate a Patient Data Report from the Home page or the Casebooks page, RDC Onsite:

• Submits a separate report job and generates a separate report for each patient that you select

• Orders the report by casebook visit

• Uses the following format to add a prefix to the report job name: PT_patient_

Note that if you specify CRF search criteria on the Casebooks page, the report includes only the CRFs that satisfy the search criteria.

To generate a Patient Data Report from the Home page or the Casebooks page: 

1. Open the Home page or the Casebooks page.

2. Select one or more patients. RDC Onsite submits a separate report job and generates a separate report for each patient that you select.

3. Click the Select patients and... field and then select Generate Patient Data Report from the list.

   
   Description of the illustration reports_pdr_hme_pg.gif
   
   

4. Click Go to immediately submit your request to generate the report. RDC Onsite confirms that the report job was submitted. You can click the Reports tab to view the status of your request.

   After RDC Onsite successfully generates the report, you can click the link in the View Report column on the Reports page to open and print your report.

Generating a Patient Data Report from the Review CRFs Page

When you generate a Patient Data Report from the Review CRFs page, RDC Onsite:

• Includes only the CRFs that you select in the report

• Generates a single report; the report may be across patients

• Places the CRFs in the same order as displayed on the Review CRFs page

• Uses the following format to add a prefix to the report job name: CRFS_

The key difference in generating a report from the Review CRFs page is that you must select each CRF to include in the report. The report orders your selected CRFs according to how they are ordered on the Review CRFs page. Although the CRFs do not follow the order of the casebook they were entered against, they do reflect the page numbers from the casebook.

To generate a Patient Data Report from the Review CRFs page: 

1. Open the Review CRFs page.

2. Select one or more CRFs that you want to include in the report.

3. Click the Select CRFs and... field and then select Generate Patient Data Report from the list.

4. Click Go to immediately submit your request to generate the report. RDC Onsite confirms that the report job was submitted. You can click the Reports tab to view the status of your request.

   After RDC Onsite successfully generates the report, you can click the link in the View Report column on the Reports page to open and print your report.

Generating a Blank Casebook Report

You generate a Blank Casebook Report to create hard copies of all the planned CRFs in a casebook. You specify the casebook to use for the report.

When you generate a Blank Casebook Report, you have two options:

• You can generate a generic blank casebook. The CRFs in the report include no CRF header information and no response data.

• You can generate a patient-specific blank casebook.

  In this case, the CRFs in the report include header information specific to the selected patient, but do not include response data. In addition, if the selected casebook is for a flexible study, the report includes all CRFs, whether they are expected for the patient or not.

  With this option, you can print a casebook for a particular patient.

To generate a Blank Casebook Report: 

1. Click the Reports tab to open the Reports page.

2. Click New Blank Casebook Report.

   
   Description of the illustration reports_sum_bcr_p1.gif
   
   

3. Click the Casebook field, and then select a casebook from the list. You must select a casebook. The Blank Casebook Report consists of all the planned CRFs for the selected casebook.

4. Specify whether you want to create a generic or a patient-specific Blank Casebook Report as follows:

   • To generate a generic blank casebook, do not specify a value in the Patient Number field. The CRFs in the report include no header data and no response data.

   • To generate a patient-specific blank casebook, click the Patient Number field and enter the ID of the patient. Alternatively, you can click the Magnifying Glass icon and select a patient ID from the list.

     In this case, the CRFs in the report include header data specific to the selected patient, but do not include response data. In addition, if the selected casebook is for a flexible study, the report includes all CRFs, whether they are expected for the patient or not.

5. Select the Date Format to use. Your options are US, Standard, European, and Swedish.

6. Select the Orientation of the report. Your options are Portrait or Landscape. This value affects only the cover page of the report. The orientation of a CRF is always defined by its layout regardless of your selection.

7. Select the job parameters for the report.

   1. Select the name of the Report Server.

   2. Enter up to 8 characters for the Job Name Prefix. RDC Onsite automatically uses a unique number as the name of a report job, and then adds your specified prefix to the beginning of the job name. You can use the prefix value to easily search for your reports in the list on the Reports page.

   RDC Onsite displays the Job Id, Job Name, and the Output File Name for your reference.

8. Click Submit Job. RDC Onsite prompts for confirmation before continuing.

9. Click Yes to generate the Blank Casebook Report.

Once you submit your request to generate the Blank Casebook Report, you can return to the Reports page to monitor the progress of your report job. You can also stop a job in progress or check error details if the report generation failed. See "Monitoring the Status and Progress of Your Report Jobs" for more information.

After RDC Onsite successfully generates the report, you can click the link in the View Report column on the Reports page to open and print your report. See "Printing a Report" for more information.

Searching for Report Jobs

You can search for a report job by name, search for report jobs currently in progress, search for report jobs already completed, or search for all report jobs. RDC Onsite displays the results of your search on the Reports page.

Note:

RDC Onsite searches for and displays only the report jobs that you have submitted. These jobs include jobs you submitted from RDC Classic and Oracle Clinical. In addition, the Reports page only lists report jobs. It does not list print jobs, scheduled jobs, or jobs under preview.

By default, RDC Onsite displays the most recent report job at the top of the list. You can click a column heading to re-sort the list based on the text in the column. You can click the column heading again to toggle between an ascending and descending sort.

To search for one or more report jobs: 

1. Click the Reports tab to open the Reports page.

2. Search for the report job you want to view.

   
   Description of the illustration reports_page_srch2.gif
   
   

   Using the options in the Search pane, you can:

   • Click Job Name and then type the name of the report job. You can use the percent sign (%) as a wildcard character in the search.

   • Click Show Jobs and then select one of the following options from the list:

     • Click All to search for both current and previous jobs.

     • Click Current to search only for the jobs currently being run.

     • Click Previous to search only for the jobs that already finished running.

   • Specify no additional search information. In this case, RDC Onsite searches for all the report jobs that you have submitted (the default).

3. Click Go to execute the search. RDC Onsite refreshes the Reports Jobs list and displays the results of your search.

   For each report job, RDC Onsite displays valuable information about each job including its name, start time, end time, and status.

   
   Description of the illustration reports_monitor01.gif
   
   

   You can use this information to monitor jobs currently in progress. See "Monitoring the Status and Progress of Your Report Jobs" for more information.

   Your other options include:

   • To view details about the job, click its link in the Job Name column. See "Viewing the Details of a Report Job" for more information.

   • To stop a job currently in progress, click the Stop icon in the Stop Report column. The icon appears only if the job is still running. See "Stopping a Report Job in Progress" for more information.

   • To open and view the report, click its link in the View Report column. The link is active only if RDC Onsite successfully generated the report. Once you open the report, you have options to print the report and save the report to your computer. See "Printing a Report" for more information.

Monitoring the Status and Progress of Your Report Jobs

Certain reports may require extended time to run. You can continue to work in RDC Onsite while the report runs in the background.

In addition, you can monitor the progress of report jobs, stop a report job currently in progress, or display details about the report job.

To monitor the status and progress of report jobs: 

1. Click the Reports tab to open the Reports page. RDC Onsite lists all the report jobs that you have submitted starting with the most recent jobs.

2. Search the list to find the report jobs you want to monitor. For each report job, RDC Onsite displays the following information:

   • Job Name — Displays the name of the report job. You can click the link to view additional details for the job.

   • Start Time — Displays the date and time that RDC Onsite started to generate the report. No time is listed if you stopped the generation of the report.

   • End Time — Displays the date and time that RDC Onsite finished generating the report. No time is listed if RDC Onsite failed to generate the report or you stopped the generation of the report.

   • Status — Displays the progress of the report generation:

     • RS_FAILURE: The report server failed to generate the report.

     • RS_SUBMITFAILED: The submit request to the report server failed.

     • SCHEDULED: Your request to generate the report has been scheduled for a specific day, date, and time.

     • STARTED: The report server has started to generate the report.

     • STOPPED: You stopped the generation of the report.

     • SUBMIT_TO_RS: Your request to generate a report was submitted to the report server.

     • SUCCESS: The report was successfully generated.

   • View Report — Displays the path name of the report file. You can click the link to open, view, and print the report. The link is active only if the report generated successfully.

   • Stop Report — Displays a Stop icon that you can click to halt the execution of a report job currently in progress. The Stop icon does not display if the job is complete.

Stopping a Report Job in Progress

You can stop the execution of a report job currently in progress. You cannot stop a job after it is complete.

Description of the illustration reports_page_stop_a.gif

To stop a report job currently in progress: 

1. Click the Reports tab to open the Reports page.

2. Search for all report jobs that are currently running.

   1. Click Show Jobs and then select Current.

   2. Click Go.

3. Click the Stop icon in the Stop Report column for the job you want to stop. The Stop Job confirmation dialog box opens.

4. Click Yes to stop the job. RDC Onsite confirms the action in the confirmation dialog box.

Alternatively, you can click a Job Name link to open another page and view details about the selected report job. If the report job is currently in progress, the page includes a Stop button so you can cancel the generation of the report.

Viewing the Details of a Report Job

There may be times when you need additional information on the status or progress of a report job. You may need to troubleshoot why RDC Onsite did not generate the report or why the process failed.

The Reports: Job Details page, as shown in Figure 11-2, provides a summary of the job executed. By viewing the details for a report job, you can:

• View the error text if the job ended in error.

• View the command line that RDC Onsite sent to the report server.

• Click a link to open the log file for the report job. Note that RDC Onsite:

  • Creates the log file and provides an active link to the file only after the status of the job has changed to STARTED.

  • Does not create the log file if the job is still being submitted to the report server (Status = SUBMIT_TO_RS) or if the submit request to the report server failed (Status = RS_SUBMITFAILED).

Figure 11-2 Details of a Report Job

Description of "Figure 11-2 Details of a Report Job"

To view additional details about a report job: 

1. Click the Reports tab to open the Reports page.

2. Click a link in the Job Name column. As shown in Figure 11-2, the Reports: Job Details page displays the following information for the selected job:

   • The job name, and the starting time, ending time, and status of the report generation. The Reports page displays the same information.

   • The error text, the command line executed, and the path name of the log file. You can click the active link to open the log file for the job. This information is helpful when troubleshooting why a report failed to generate.

     Note that RDC Onsite provides an active link to the log file only after the status of the job has changed to STARTED. In addition, RDC Onsite does not create the log file if the job is still being submitted to the report server (Status = SUBMIT_TO_RS) or if the submit request to the report server failed (Status = RS_SUBMITFAILED).

   • The name of the report server.

   • The path name of the report file. You can click the link to open, view, and print the report. The link is active only if the report generated successfully.

   • A Stop button, if the job is currently running. You can click the button to halt the execution of a report job currently in progress. The Stop icon does not display if the job is complete.

Printing a Report

The Patient Data Reports and the Blank Casebook Reports are PDF files. You can view a report using any application that opens PDF files, such as Adobe Reader. In addition, you can print the report or save a copy of the report to your PC.

To print a report: 

1. Click the Reports tab to open the Reports page.

2. Search for the report you want print.

3. Click the link in the View Report column to open and print the report.