Accessibility

Oracle Clinical assigns a status to each DCI, which indicates its stage in the data entry process. The system displays the status each time you open the DCI. (The status of the DCI is visible in the Status field of the DCI header.) Based on the status and the occurrence of batch validation, the system designates the accessibility of each DCI. Accessibility determines how certain other functionality proceeds. Specifically, auditing of data changes is directly affected by the accessibility of a DCI.

There are three "levels" of accessibility:

• not accessible

• internally accessible

• externally accessible

A DCI is not accessible until it becomes internally accessible. This means that until the DCI becomes accessible, the system permits you to enter and update data using the Initial Log-in and the first- and/or second-pass data entry windows. Also, the system does not prompt you for a change reason when you do make updates.

When a DCI reaches the entry complete status, it becomes internally accessible. This status is dependant on the definition of the DCI, specifically, whether single- or double-pass data entry is required. For a single-pass document, the system defines the DCI as internally accessible when it is Pass 1 Complete status. If you want to update a DCI that is internally accessible, you use the Update window. If you want to update the DCI header data, you use the Key Changes window. When you make changes to the data, the system displays the Audit Change Reason window, which prompts you select a change reason and include an explanatory comment, if necessary.

When an internally accessible document undergoes batch validation, it becomes externally accessible. This level of accessibility allows the document to be made available to users out the data entry group.

The following sections describe the process of entering a CRF into Oracle Clinical. They provide an overall picture of the process and understand many of the tasks. To more fully understand the features of working in the Data Entry modes, refer to the Oracle Clinical Administrator's Guide.