F. eCRFs

For institutional studies at Washington University that have chosen to use OnCore as the designated Electronic Data Capture (EDC), coordinators will fill out the electronic Case Report Forms (eCRFs) in the OnCore System. The forms are tied to the OnCore calendar. If your study will utilize eCRFs within OnCore, this section will help you understand the steps you or your team will need to go through in order to ensure the eCRFs are fully functional before the study opens and then how to proceed with capturing data once the study is open. 

eCRF Creation Process

1. Data dictionary is created by Protocol Development (PD) and submitted to PRMC during Study Startup; the data dictionary contains a list of fields organized by form that will be required for the study
2. Forms are created by PD in OnCore’s Forms Console
3. Study Coordinator reviews the forms with status of “new” in OnCore’s Forms Console
4. PD makes necessary edits based off of Coordinator review
5. After Coordinator approval, Biostatistician reviews the forms
6. PD makes necessary edits based off of Biostatistician review
7. After Biostatistician approval, forms are attached to a Test Protocol located in the production server
8. Data for 2-4 fake/test patients are entered on forms by the Coordinator to validate functionality with calendar
9. PD makes necessary edits
10. After Coordinator approval, forms are attached to the live calendar in OnCore and relevant sign-offs are completed

Once the eCRFs and the study calendar have been created in OnCore, they will need to be tested to ensure full functionality. Please refer to the Reviewing eCRFs page to learn how to complete this task.