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. When you open this PDF file in Adobe Acrobat, the Oracle Clinical eCRF tool will be active.

You then open the Oracle Clinical eCRF tool and using the Annotated eCRF Tool feature, 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.

Note:

After you enable the Oracle Clinical eCRF tool, it is visible if you open any PDF file and not just for the Annotated CRFs. The tool however has no effect on other PDF files.

After the GLE generates the PDF file, there is no further connection to the GLE or to Oracle Clinical. The file that is displayed in the PDF window 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. 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. Also, you can re-open the Oracle Clinical eCRF Tool and change its settings as often as necessary, either to fine-tune the information in the annotations or to create multiple copies 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 Standard DC 21 or Adobe Acrobat 2020 (Classic Track) installed on your system in order to generate annotated CRFs. Also, the current version of the OPA PDF plug-in must be installed.

Both Adobe Acrobat and OPA-Plug-in are required to manage annotated CRFs.

To enable the Oracle Clinical eCRF Annotation Tool, the annotated CRFs PDF files must be downloaded and opened in Adobe Acrobat.

Configure Browser to Download Annotated CRF PDF Files

To configure the Microsoft Edge (Chromium) browser:

1. Open the Microsoft Edge browser.
2. From Menu on the top right, select Settings.
3. Select Cookies and site permissions in the left panel.
4. Under the Site permissions > All permissions section, select PDF Documents.
5. Turn on the Always download PDF files toggle.
6. Relaunch the browser.

To configure the Google Chrome browser:

1. Open the Google Chrome browser.
2. From Menu on the top right, select Settings.
3. Select Privacy and Security in the left panel.
4. Select Site Settings.
5. Scroll down to the bottom and select Additional Content Settings.
6. Select PDF documents.
7. Select the Download PDFs option.
8. Relaunch the browser.

PDF files will now be downloaded and opened in Adobe Acrobat, instead of opening the file within the browser window.

Note:

If you open an annotated CRF file within a browser window, the Oracle Clinical eCRF Tool will not be displayed.

Opening multiple PDF files within the same Adobe Acrobat instance is not supported in the current version of the OPA Plug-in.

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.