Data Entry and Expectedness

In this section:

• Data Entry in Remote Data Capture Onsite
  
• Data Entry in Oracle Clinical
  

Data Entry in Remote Data Capture Onsite

Remote Data Capture (RDC) Onsite displays blank CRFs in the Casebooks page only if the corresponding DCI is expected for the patient. In addition, when a data entry operator clicks Next in the data entry window, the next CRF expected for that patient in the current CPE appears, regardless of which CRFs may be expected for other patients in the same study.

DCIs that are the target of a rule are expected for a patient only when:

• The Interval containing their CPE is expected for the patient.

• The trigger condition of the DCI rule is met for the patient.

• The status of the patient's RDCI for the trigger DCI is Batch Loaded, Pass 1 Complete, or above.

• The patient is not frozen.

• The RDCI is at subevent 0.

• The DCI that contains the trigger is expected.

Note:

The Blank Casebook report, including the version with header information for a particular patient, does not consider expectedness for the patient. It includes all DCIs in all Intervals, whether or not they are expected for the patient at the time the report is generated.

If sites are printing the blank casebook and using it for data entry, be sure to provide instructions for entering data for the correct DCI Book pages. You may want to provide a visual cue for trigger Questions in the graphic layout.

Data Entry in Oracle Clinical

If a DCI Book with rules is used for manual data entry in Oracle Clinical:

• All DCI Book pages are available for data entry whether they are expected for a patient or not. You must provide instructions to data entry operators to ensure that they enter data for the correct DCI Book pages.

• Interval and DCI Rules are triggered if data entered through Oracle Clinical meets the defined trigger conditions. If you use a mix of data entry methods in a single study, DCIs and Intervals that become expected for a patient due to data entered in Oracle Clinical are displayed as expected for the patient in RDC.