Customizing the Electronic Signature (Approval) Warning Message

Whenever a user approves a CRF or a group of CRFs in RDC, the approval represents an electronic signature provided in accordance with FDA 21 CFR Part 11.

Every time the user approves a CRF or undoes the approval for a CRF, RDC issues a standard warning message that appears in the same window as the approval. You can customize this message.

Users can select options in the Data Entry window or options on the application pages to approval CRFs. Therefore, if you decide to customize the approval warning message, make sure you change the message for both locations in the user interface.

For more information, see:

• Customizing the Approval Warning Messages for the Data Entry Window
  
• Customizing the Approval Warning Messages for the Application Pages
  
• Other Options for Customizing Approvals
  

Customizing the Approval Warning Messages for the Data Entry Window

To customize the approval warning messages for the Data Entry window:

1. Make a copy of olsardc.ear from OPA_HOME: OPA_HOME\rdc\olsardc.ear.
2. Open olsardc.ear using any utility to unzip.
3. From there traverse to the location of de_external.properties in the following path:

   olsardc.ear\RdcSurroundAdfWebUIWebApp.war\WEB-INF\lib\rdcdataentry.jar\oracle\pharma\rdc\de\resource\properties\de_external.properties

4. Open the de_external.properties file with a text editor.
5. Modify the Approval warning message:
   1. Find the following text string:

      de.dcs.approve.signoff=

   2. Change the text following the equal symbol (=) to the message that displays when the user approves a CRF from the Data Entry window. The default text is:

      de.dcs.approve.signoff=IMPORTANT By approving this CRF page, you confirm that all data on the page is complete and correct. This approval is equivalent to an electronic signature.

6. Modify the Undo Approval warning message:
   1. Find the following text string:

      de.dcs.unapprove.signoff=

   2. Change the text following the equal symbol (=) to the message that displays when the user undoes the approval from the Data Entry window. The default text is:

      de.dcs.unapprove.signoff=IMPORTANT By undoing approval, you are rescinding the electronic signature on this page.

7. Save your changes.
8. Click Ok when prompted to replace the modified files in the war and ear.
9. Close the unzip utility.

You now need to deploy the customization. See Deploying Customizations for instructions.

Customizing the Approval Warning Messages for the Application Pages

To customize the approval warning messages for the application pages:

1. Stop the WebLogic Admin Server.
2. Log in to the RDC application server.
3. Navigate to OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa54 under HKEY_LOCAL_MACHINE > Software > Oracle.
4. Modify the Approval warning message:
   1. Find the following text string:

      prompt.ApproveCrfWarning2=

   2. Change the text following the equal sign (=) to the message that displays when the user approves a CRF from an application page. The default text is:

      prompt.ApproveCrfWarning2=By approving this group of CRFs, you confirm that all data are complete and correct. Each approval is equivalent to an electronic signature.

5. Modify the Undo Approval warning message:
   1. Find the following text string:

      prompt.UnApproveCrfWarning2=

   2. Change the text following the equal sign (=) to the message that displays when the user undoes the approval from an application page. The default text is:

      prompt.UnApproveCrfWarning2=By undoing the approval of this group of CRFs, you revoke prior certification that the data was complete and correct. Each un-approval is equivalent to removal of an electronic signature.

6. Save your changes.
7. Restart the WebLogic Admin Server instance.

Other Options for Customizing Approvals

In addition to customizing the approval warning messages, you can:

• Disable approval from RDC. See Allowing CRF Group Actions for more information.
• Set a timeout value for pre-population of user name for approvals. See Configuring a Timer Period for Subsequent Electronic Signatures for more information.