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 Graphic 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 OK. The system creates a discrete PDF file. This is possible only if an extension for Adobe Acrobat is installed in the browser. Else, it prompts you for what you need to do based on the setting for download.
3. Open the PDF file using Adobe Acrobat, and click on the Oracle Clinical eCRF tool. 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 5.4 compatible application server>:<Port>/opa54/ocdcitemplate.htm.

   Note:

   Make sure you have access to this feature. Instructions are available in unresolvable-reference.html#GUID-F4ED963E-420B-409C-9199-771EE8CD2652 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:

• Saving an Annotated CRF
  
• Opening a Saved Annotated Form
  

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.

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, use this procedure to re-open it.

1. Open Adobe Acrobat.

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.

When the form opens in the Adobe Acrobat window, the Adobe Acrobat and the OPA plug-ins Oracle Clinical eCRF tools are activated. This gives you access to all of Acrobat's functionality, as well as that of the Oracle Clinical eCRF Tool.