Oracle Clinical Management of Unplanned DCIs

When CRF page tracking is enabled for the study, the DCI definition includes information to specify the expected number of pages, as well as a numbering scheme to use for both planned and unplanned DCIs in the book. A DCI is regarded as planned or expected if it is in a DCI book, has a clinical planned event assigned, and an actual event number of zero. Anything else is regarded by the system as unexpected.

Unplanned Scenarios:

Oracle Clinical tries to find the last page of the relevant DCI book for the specified visit. Oracle Clinical adds one unit to that page number, using the unplanned numbering scheme for the specified DCI. If that page number already exists in the book, Oracle Clinical assigns a temporary page number that consists of an "x" concatenated with a sequence number.

If there is no entry in the DCI book for that visit, Oracle Clinical finds the last page of the book and adds one unit, using the unplanned numbering scheme for that DCI.

A relevant DCI book is defined as follows:

• a book assigned to a patient

• if no book has been assigned to a patient, the book used to sequence the log-in function

• if no book is used to sequence the log-in function, the default book defined at the study level