Procedures

In this section:

• Annotating a DCI Form
  
• Annotating all DCI Forms in a Single Study
  
• Working with an Annotated CRF in Adobe Acrobat
  

Annotating a DCI Form

The annotated CRF that this process described here generates, provides all of the components that are required for an annotated CRF, suitable for inclusion in regulatory submissions. You initiate the process of creating an annotated CRF from the Graph Layout Editor (GLE).

The procedure described here is also applicable if you want to annotate a Form Layout Template (FLT) or a DCM layout.

For more information, see:

• Procedure
  
• Notes
  

Procedure

To create an annotated DCI form:

1. Open the DCI form in the GLE and click the Create Annotated Layout command in the File menu. The system opens the Print Preview Annotated Layout window.
2. Select a report server and click the OK button. The system opens the PDF in an Internet Explorer instance, with the RDC Toolbar displayed.
3. Click Annotated CRF on the RDC toolbar. The system opens the CRF Annotation Tool window; see Using the CRF Annotation Tool Window.
4. In the CRF Annotation Tool window, select the options that will display the required annotations in the form.
5. Click the OK button. The system creates the annotations as PDF comments and displays them in the CRF.

Notes

1. Because the annotations are Adobe Acrobat comments, you can use any of the tools that are available in Acrobat to change how annotations are displayed, printed, or saved.
2. If you want to change how any of the annotations are constructed or displayed, open the CRF Annotation Tool, change settings, and click the OK button to re-display the annotations.
3. Use the Adobe Acrobat Save button to save the annotated CRF as PDF file.

Annotating all DCI Forms in a Single Study

To generate all Annotated DCI Forms in a specified Study (all Form versions of all DCI's) in a single request, perform the following:

1. In a web browser, enter the URL for the upgrade utility. For example, https://<Oracle Clinical 5.2.2 compatible application server>:<Port>/opa53/ocdcitemplate.htm.

   Note:

   Make sure you have access to this feature. Instructions are available in section B.1 of the Oracle Clinical Remote Data Capture Onsite Administrator's Guide.

2. Log in to the upgrade utility using your Oracle Clinical user ID and password.

   The Study Level CRF Generation Tools form lists all the DCI Form Definition Enabled studies that your user ID can access.

3. Select a study by clicking a row. Make sure the entire row is highlighted in blue to indicate that the study has been selected. Although you can select multiple studies, Oracle recommends that you generate forms for only one study at a time.
4. Click Annotated Layouts.
5. In the Annotated Layouts window, select the desired Report Server.
6. Click Continue.

   A job is initiated to generate an Annotated CRF for every DCI layout in the study for which a DCI Form Version has been generated previously. Note that this job does not run in the background and will take some time.

   The Generation Status field in the lower left of the form shows each DCI form version as it is being processed. On the same form, when the job completes, you can select View Log to see whether the application encountered any errors during the execution of the job.

   Annotated CRF's generated through the Study-level option will remain as individual output files (that is, not a single batched output for the entire Study) created in the specified Report Server's log directory.

Working with an Annotated CRF in Adobe Acrobat

When you generate an annotation from the Graphical Layout Editor, Oracle Clinical creates a standalone PDF file that you can manage as needed. This includes adding comments to the file that are in addition to the annotations. Essentially, you can use all of Adobe Acrobat's functionality to further modify the annotated CRF file.

For more information, see:

• Displaying Acrobat Toolbars
  
• Saving an Annotated CRF
  
• Opening a Saved Annotated Form
  
• Methods of Organizing and Viewing Annotations
  

Displaying Acrobat Toolbars

Because annotated CRFs are displayed in the PDF DEW, you do not have access to the Adobe Acrobat menus. Therefore, you should display several of the Acrobat toolbars so you can access certain features that assist in the review and maintenance of your annotation files. You may find these toolbars helpful:

• Basic

• Commenting

• File

• Tasks

To access any toolbar, right-click in the toolbar area and select an item in the drop-down list. You can also move the toolbars once they are displayed.

Saving an Annotated CRF

You save an annotated CRF in the same way that you save any other PDF file in Adobe Acrobat. You can save multiple copies of the annotated PDF.

Note:

Ensure the File toolbar is displayed, which gives you access to the Save Copy button.

To save a copy of the annotations, click the Save a Copy button, which is in the Acrobat File toolbar. The system displays the Save a Copy... window, which you use to select a directory and file name for the new file. The file is saved in PDF format.

Opening a Saved Annotated Form

When you create an annotated form, the system creates a PDF file that you can then save, copy, and modify further. When you save and close the annotated form and the PDF DEW closes, use this procedure to re-open it.

1. Open Microsoft Internet Explorer.

2. Choose Open... from the File menu.

3. In the Open window, use Browse to locate the saved annotated form and open it. The form will have a *.pdf extension.

4. When the form opens, you have access to the Acrobat tools and the PDF DEW Annotation. Use either to review or modify the annotated file.

Notes

1. When the form opens in the browser window, the Adobe Acrobat and the OPA plug-ins are activated. This gives you access to all of Acrobat's functionality, as well as that of the CRF Annotation Tool. In order to use the CRF Annotation Tool, the form must be opened within a Microsoft Internet Explorer window.
2. You can open an annotated PDF file in Adobe Acrobat, however the RDC toolbar, which is a component of the PDF DEW and includes the Annotated CRF button, is only available when you use Internet Explorer to open the file.

Methods of Organizing and Viewing Annotations

Because annotations are PDF comments, you can use the Adobe Acrobat Comments List feature to list, review, and modify them. You access the Comments List either by clicking the Comments tab in the lower left-hand corner of the PDF DEW or the Comments List command in the Review & Comment drop-down list.