Adding and Updating an Investigator Comment

When you are entering or updating the patient data in a CRF, you can add and update investigator comments associated with a response value (that is, a CRF field).

You can perform these actions:

• Only from the Data Entry window
• Only if you have update privileges

• Only if your sponsor has configured RDC Onsite to support investigator comments

To add or update an investigator comment:

1. Open the CRF in the Data Entry window.

2. Position the cursor in a field and then click the Investigator Comment icon in the toolbar.

   Alternatively, you can right-click a field in the CRF, and then select Investigator Comment from the menu.

   RDC Onsite opens either the Add or the Update Investigator Comment dialog box depending on the selected field.

3. Click the Investigator Comment field.

   • If the field does not have an investigator comment, enter new comment text.
   • If the field already has an investigator comment, review and modify the existing text. You can add, edit, and delete comment text.

4. Click the Change Reason field, and then select an explanation for this change from the list. Note that:

   • If the CRF status is Saved Complete, and you add an investigator comment, you may or may not need to provide a change reason as configured by your sponsor.
   • If the CRF status is Saved Incomplete, you are not required to specify a change reason when you add or update an investigator comment.
   • If you modify a previously saved investigator comment, you must enter a change reason.
5. Click the Change Comment field if you want to provide any additional information about your changes or comments.
6. Click OK to save your changes.