Understanding Oracle Clinical

Building a Study

When you set up a new study, you can typically reduce the workload by reusing pages from the GLIB or from other studies. However, the standard pages for your first RDC studies may require significant editing to make them more user-friendly for site personnel. Common changes to accommodate remote data capture include adding instructions to the DCMs and ensuring that the final product looks nice enough to serve as a final patient data report. It's not a coincidence that both of these are affected by how your DCM is laid out.

DCMs

Screen layouts

In classic OC entry, the DCM is a simple tool for full-time data entry personnel to use. But in RDC, the DCM contains additional text or illustrations and is used by both site coordinators and monitors who don't spend 40 hours a week looking at data entry screens. Furthermore, the electronic screens may completely replace the paper CRF forms; this requires that pertinent instructions also move from the paper to the electronic screens. You may discover that a screen that once simply recorded blood pressure now contains detailed instructions regarding what to do if the 3 readings are more than 20 points different. In short, your screens may be much busier, and this extra text will take more time to set up correctly.

There is an ongoing debate about whether or not electronic screens should look exactly like paper CRFs. In my opinion, the answer is no, as there is no need to duplicate information in free text that can be covered by ...