Operator Comments

As you enter responses from the CRF into the RDCI, you may find errors the Investigator made. However, your company's procedures may require you to enter the response exactly as it appears on the form.

You can use the Operator Comment window to record a comment about how the response appeared on the CRF. Your comment creates a manual discrepancy, which is recorded in the discrepancy database.

To record a manual discrepancy:

1. Position the cursor in the response field for which you want to enter the operator comment.
2. Select the [Operator Comment] function. The Operator Comment window appears. Enter information in the following fields:

   Operator Comment Reason—A default reason is automatically filled in. If this is not correct, make a selection from the list of values.

   Comment—Enter your comment.

3. Select Save to save the comment and return to the original Data Entry window. The Data Entry window is re-displayed, with the cursor at the beginning of the original input field. Select Cancel if you decide not to make the comment.

A value with an operator comment displays in blue, and an operator comment lamp (<Oper.>) displays in the Data Entry window title. If there is also an Investigator comment for the field, the value displays in red to indicate the presence of multiple comments or discrepancies, and all the appropriate lamps are displayed in the window title.

You can change the Discrepancy Review Status or Resolution if the Resolve Discrepancies During Data Entry configuration setting is enabled.

In Browse mode, the configuration setting Manual Discrepancy in Browse determines whether you can create Operator Comments.