1. Registration and Eligibility Checklist Set Up in OPEN Diana Meyer OPEN Administrator

2. 9/18/2008OPEN Conference2 Registration and EC Set up in OPEN The purpose of this presentation is to establish guidelines for form definition in the Oncology Patient Enrollment Network (OPEN). This includes CDE Compliance requirements for forms, eligibility checklist development, forms rendering, and updating forms in OPEN. This process is documented in the Form Definition in OPEN Procedure

3. 9/18/2008OPEN Conference3 Responsibility Initially, those individuals from CTSU with the role of “Administrator” in OPEN will be responsible for administrative tasks After the first protocol has been established in OPEN, the group will take on administrative tasks for their subsequent protocols The role of “Administrator” will be assigned at the group and the role is captured on their respective roster in RSS

4. 9/18/2008OPEN Conference4 Steps for Building a Form in OPEN Download form from caDSR Define form layout Modify widget types Test data exchange Apply edit specifications Test edit specifications

5. 9/18/2008OPEN Conference5 Form Download from caDSR The form is downloaded into OPEN by using the caDSR Public Id. The basic eligibility checklist is created in caDSR and then is downloaded into OPEN.

6. 9/18/2008OPEN Conference6 Questions Screen This screen allows the user to change the appearance of questions in the checklist. Questions may be made mandatory, editable, hidden, or uppercase. Each form is assigned a unique Form Id.

7. 9/18/2008OPEN Conference7 Questions Screen A “Notes” feature is available to add additional instructional information on the form. A default value can be assigned to questions in the form Widget types may be specified here.

8. 9/18/2008OPEN Conference8 Form Layout Rows, columns and cells can be manipulated to change the layout of the form. Information is grouped in modules as defined in caDSR. This screen allows the user to change the appearance of the checklist.

9. 9/18/2008OPEN Conference9 Data Exchange Testing After the form layout is completed, data entry testing is performed by CTSU to ensure correctness The group is then given the new metadata files Data exchange testing is performed to ensure that metadata is correctly exchanged between OPEN and the group randonode Group verifies the communication between their randonode and OPEN

10. 9/18/2008OPEN Conference10 Edit Specification Process Edit Specifications are provided by group Administrator creates edits in OPEN Edit specifications are tested according to Edit Specifications in OPEN Procedure Testing documentation is provided to the group Group gives final approval for moving form to production Updated form is put into production

11. 9/18/2008OPEN Conference11 Edit Checks Edit Specifications provided by group for each protocol are listed in this screen. The edit “test button” allows user to test validity of edit specifications. This screen allows the user to create and maintain edit specifications for the checklist.

12. 9/18/2008OPEN Conference12 New Edit Check Screen Edit check type may be generic or custom. Option to allow override is available for questions Failure type may be either “Alert” or “Error” Edit Check may come directly from the group.

13. 9/18/2008OPEN Conference13 Edit Specifications Testing Procedure CTSU IT staff verifies validity of all edit checks Edit specifications are tested with the edit specification test check Data entry testing is then performed Testing results are captured in the database and also documented in the Edit Specifications Spreadsheet Group gives final approval of edit specifications

14. 9/18/2008OPEN Conference14 Edit Check Test This screen allows user to test each edit specification. After the edits are completed, they are tested using the edit specification test check in this screen. Valid, invalid, and null values are entered here for test records.

15. 9/18/2008OPEN Conference15 Edit Check Audit Feature This feature allows the user to record edit test result information. After the test result, the edit check audit records if the test worked as expected by the user. The Edit Check Audit data is available in report format.