Discussion

Although you can use an FLT or DCM block layout to create an annotated form at any time during the CRF design process in order to aid your internal mapping and/or auditing procedures, the primary purpose of creating an annotated CRF in OC/RDC is for inclusion in regulatory submissions. For this usage, you start with a DCI form layout. Oracle recommends that you create an annotated CRF for each version of a DCI form layout you use and, if you modify a form during a study, that you create an updated annotated CRF for that form.

Note that the process of creating an annotated form from a DCM Block layout or an FLT layout is identical to that described for the annotated CRF.

The process of creating an annotated CRF is straightforward. When the DCI graphical layout is finalized, you use the GLE to create an "annotation-ready" PDF of the layout and open it in the PDF DEW. When you open this file in the PDF DEW, the system recognizes that it is annotation-ready and only the CRF Annotation toolbar button is active.

You then open the CRF Annotation tool and select a series of settings that control both the type of annotations to include in the PDF and how you want it displayed. Then you save the annotated form to your file system.

When the GLE sends a copy of the DCI layout to the PDF DEW there is no further connection to the GLE or to Oracle Clinical. The file that is displayed in the PDF DEW is standalone – you can copy, save, or delete it and there is no impact on the DCI layout in OC. If you subsequently update the DCI form in the GLE, those changes are not transferred to a previously generated annotated CRF that is open in the PDF DEW. In that case, you would simply create another annotated CRF.

Since the annotated CRF is separate from the DCI layout in the GLE, you can use the tools included with Adobe Acrobat to modify it as you see fit. It is a discrete PDF file, that you can save, add further comments to, make a copy of, or delete, all within the functionality of Acrobat. In addition, you can re-open the CRF Annotation Tool and change its settings as often as necessary, either to fine-tune the information in the annotations or to create multiple copies form with different annotation configurations.

For more information, see:

• Definition
  
• Requirements
  
• Annotation Placement Styles
  

Definition

An annotated CRF is generally defined as a blank CRF with markings, or annotations, that coordinate each datapoint in the form with its corresponding dataset name. Essentially, an annotated CRF communicates where the data collected for each Question is stored in the database.

In Oracle Clinical, the annotated CRF provides linkage between database objects and the DCI and DCM definitions, and DCM Questions and Question Groups, as these definitional objects are laid out in the associated DCI layout.

Requirements

You must have Adobe Acrobat 6.0.3 installed on your system in order to generate annotated CRFs. In addition, the current version of the OPA PDF plug-in must be installed. Note that the PDF DEW that you use to manage annotations is comprised of the Adobe Acrobat and OPA plug-ins running in an instance of Microsoft Internet Explorer. If you open an annotated CRF file in the Adobe Acrobat window, the RDC toolbar will not be displayed.

Note:

Oracle recommends setting your screen to 16 bit or greater color quality; this ensures proper display of the Text and Background color buttons.

Annotation Placement Styles

There are two "styles" for placing the annotations on the form: In Place and Index. You use the Annotation Placement Setting setting to determine which to use. There are certain differences between the two that may affect which you select.