Understanding the Data Entry Process

Every DCI begins with a header window, which Oracle Clinical uses to collect the information that uniquely identifies the DCI. For example, the header stores such information as the study and site names, the visit and patient number, and the visit date. The system provides some of this information, and you supply other items during initial data entry. When the system validates all of the header information, one or more DCMs displays. Each DCM is a logical grouping of questions collected together at a visit. The minimum configuration for a DCI then, is the header information plus one DCM.

When data entry occurs, your organization has defined a set of Data Collection Instruments (DCIs) that you use to collect the data that is saved, or committed, to the study database. Each DCI is modeled on the Case Report Forms (CRFs) that are utilized in the study to collect data at the clinical sites. The DCI is comprised of an informational section, which holds information about the data, such as the patient number and visit date, and one or more question section, which are named Data Collection Modules or DCMs.

1. Log-in the DCI header
2. First-pass data entry
3. Second-pass data entry

Entering a single CRF in Oracle Clinical is also a two-stage process: entering the header information, and entering the data. This process can be a single operation or separated into two. If a second pass is required, then after the first-pass data is validated the DCI can be invoked in second-pass data entry mode.