Traditional and Enhanced DCI Books

You can organize DCIs, which generally correspond to CRFs, into a casebook and assign them to visits (Clinical Planned Events, or CPEs) by creating a DCI Book. DCI Books are required if you are using Oracle Remote Data Capture (RDC) and can be used for Oracle Clinical data entry too.

Before you can define a DCI Book you must define Intervals and Clinical Planned Events (CPEs) as well as Questions, Question Groups, DCMs, and DCIs; see Treatments and Schedules Questions and Question Groups and DCMs and DCIs

Oracle Clinical provides two types of DCI Books for use in different types of clinical trials:

• DCI Books
  
• Enhanced DCI Books
  

DCI Books

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.

The traditional DCI Book is suitable for paper-based clinical trials for which you want to use the Oracle Clinical Page Tracking feature. This feature helps ensure that all paper CRFs are collected and their data entered. If your study uses the Page Tracking feature, you must use the original DCI Book type. See Defining a Traditional DCI Book and Using CRF Page Tracking for more information.

Enhanced DCI Books

Enhanced DCI Books offer:

• Support for Flexible Studies

• Additional Features You can use enhanced DCI Books to take advantage of these features even if your study does not have a flexible design, as long as you do not use Page Tracking.

• Support for Flexible Studies
  
• Additional Features
  

Support for Flexible Studies

The enhanced DCI Book is suitable for flexible trial designs such as studies with multiple treatment arms and cohorts (groups of patients) with different assessments. In these trials, patients receive different assessments based on data collected during the trial. For example, a flexible study design for an oncological indication might require different disease states to have different schedules and assessments, with patients with more rapidly progressing disease being evaluated and dosed more frequently and patients with less rapidly progressing disease states being evaluated less frequently.

Open-ended cycling trials are also supported. You must define an adequate number of CPEs and Intervals and add them to the Enhanced DCI Book. You can add more during the course of the trial if necessary.

When you use an Enhanced DCI Book, the following flexible study features are supported:

• Data-Triggered Rules: You specify data points that determine which CRFs, CPEs, and Intervals are required, or expected, for each patient.

• Data Expectedness Calculation for Each Patient: As soon as data is saved for a patient at one of these predefined points (or the system completes a batch job that may impact data expectedness for a patient), the system recalculates which CRFs and Intervals are expected for the patient, based on the defined rules.

• Display of CRFs in RDC Onsite: For each patient, the Casebooks page displays only the CRFs that are expected, and as the user enters data and clicks Next, the next CRF expected during the CPE for that particular patient opens. Any CRFs that have been entered but are no longer expected are still displayed.

  Note:

  In other manual Oracle Clinical and RDC data entry interfaces all CRFs included in the DCI Book are available for data entry, not just those expected for the patient.

• Validation: You can define an Enhanced DCI Book in any order and then run a validation utility that checks rule definitions against DCI, CPE, and Interval definitions and identifies any invalid conditions so that you can fix them; seeValidating an Enhanced DCI Book.

Additional Features

Enhanced DCI Books include other features that are helpful whether your study is defined as flexible or not:

• Navigation: You can create, maintain and view the DCI Book pages for a selected CPE without navigating through all the pages for the book; see Navigator: Building an Enhanced DCI Book.

• Copying: You can copy all the DCI Book pages for a single CPE and insert them into another CPE.

• Deleting pages: You can delete all the DCI Book pages for a single CPE at once.

• Renumbering pages: You can run a utility to automatically renumber any range of Start Page numbers in CPE and DCI order, using prefixes and/or suffixes you specify. You can insert or delete a DCI in the middle of the study, or assign DCIs to CPEs in any order, and then run the utility to fix the Start Page numbers.; see Numbering and Renumbering Pages.

• Validation: The validation utility checks Start Page numbers and gives a warning if they are nonsequential. You can choose to continue with nonsequential page numbers or you can use the renumbering utility.