DCI Structure
DCIs are created prior to the data entry stage. However, since DCIs are the basis in Oracle Clinical for capturing the CRF information, this section illustrates several possible examples for DCI creation.
Consider the case of a study that requires vital signs, a blood chemistry workup, and a urinalysis performed at each visit for 3 visits. The possible configurations for building the necessary DCIs are numerous. Beginning with three component DCMs, one containing vital signs questions, one containing blood chemistry questions, and one containing urinalysis questions, there are still many possible sets of DCIs, three of which are illustrated below.
Example 1:
Each DCI includes a single DCM. Therefore, entering the data for each visit requires three DCIs.
Example 2:
One DCI per visit that includes all three DCMs. Therefore, entering the data from each visit requires a single DCI.
Example 3:
One DCI to collect the vital signs for all visits, and a separate one for both of the other DCMs. Therefore, entering the data from each visit requires two DCIs, and one would be ongoing through the study.
Parent topic: Entering Data