Defining a Traditional DCI Book

Note:

The Page Tracking feature has been deprecated from Oracle Clinical release 5.4 onward. However, pre-existing studies created on earlier Oracle Clinical versions with Page Tracking already enabled will continue to function as previously configured, hence the associated documentation pertaining to this use-case has been retained as below. This content is subject to be removed in future releases.

You use a DCI Book to sequence the order of DCIs and their default keys during the data entry login process. This sequencing simplifies the process of entering CRFs, which are themselves sequenced in a predefined order. Most companies enter CRF information from a clinical record book organized in CPE sequence. You can use Oracle Clinical's DCI Book feature to create the electronic equivalent, with the DCIs, which correspond to the CRF pages, ordered as the information in the clinical record book appears. In this way, a DCI Book is like an index to the clinical record book. (When you add a DCI to the DCI Book Pages, the system automatically adds it to the DCI Book Constraints and marks it as "Planned in Book." You can specify DCI version usage for a book, and set a policy for which DCIs can or cannot be used for unplanned events. See Defining a Traditional DCI Book. See also Using CRF Page Tracking, for instructions on enabling DCI Book page tracking.)

A study can have many DCI Books for different purposes, or just one for the whole study. You give each DCI Book a unique name. A login entry operator chooses the DCI Book appropriate for a CPE's CRFs.

You can define the pages of the DCI Book by selecting the DCI Book Pages button to invoke the DCI Book Pages window.

Note:

Oracle recommends not creating non-sequential CPE numbering for pages in DCI books. Among other problems, non-sequential CPEs do not display in RDC.

For more information, see:

• Creating a DCI Book
  
• Defining DCI Book Constraints
  

Creating a DCI Book

You define a DCI Book by navigating to Definition, then DCIs, and DCI Book. The Maintain DCI Book form opens, displaying the DCI Books window. Enter the name and a description of the DCI Book. If you define more than one DCI Book, you can select one as the default to offer when you choose a DCI Book at login.

You give each DCI Book page a page number, the name of a DCI, and, optionally, the name of a CPE. Omitting the CPE might be useful when you have a set of optional DCIs not pre-allocated to particular CPEs.

The page numbers are the page numbers of the first page of the CRF that corresponds to the DCI. The page numbers must be unique; if you have multi-page CRFs corresponding to a single DCI, the page numbers will not be continuous. You do not have to enter the pages sequentially, but the form sequences them in ascending page order when you re-query. See the following section for enabling CRF page tracking in a study created in Oracle Clinical 3.1 or later.

When you add a DCI to DCI Book pages, the system also adds it to the DCI Book Constraints table.

Defining DCI Book Constraints

This functionality is the same in traditional and enhanced DCI Books; see Defining DCI Book Constraints for information.