11 Annotating CRFs

As part of your internal processes and/or a component of a regulatory submission, you may find it necessary to annotate the CRFs you use in a protocol. Oracle Clinical provides the capability to create an annotated CRF from a DCI graphical layout via the Graphic Layout Editor (GLE). The annotated CRF that you create in Oracle Clinical uses the names of the fields you setup in the GLE, as well as any other attributes you specify. The annotations are either located adjacent to each field or else a number is used to associate each field with its annotation in a footnote. Because this process is automatically generated and extensively customizable, the process of annotating your CRFs using Oracle Clinical is can be integrated into your normal CRF design workflow.

This section discusses where in your CRF design workflow you may find it advantageous to generate annotated CRFs, describes the procedures you use to create them, and defines the tools you use in these procedures.

For more information, see: