Registration and Eligibility Checklist Set Up in OPEN

Diana MeyerOPEN Administrator

9/18/2008 OPEN Conference 2

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

9/18/2008 OPEN Conference 3

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

9/18/2008 OPEN Conference 4

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

9/18/2008 OPEN Conference 5

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.

9/18/2008 OPEN Conference 6

Questions ScreenThis 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.

9/18/2008 OPEN Conference 7

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.

9/18/2008 OPEN Conference 8

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.

9/18/2008 OPEN Conference 9

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

9/18/2008 OPEN Conference 10

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

9/18/2008 OPEN Conference 11

Edit ChecksEdit 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.

9/18/2008 OPEN Conference 12

New Edit Check ScreenEdit 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.

9/18/2008 OPEN Conference 13

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

9/18/2008 OPEN Conference 14

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.

9/18/2008 OPEN Conference 15

Edit Check Audit FeatureThis 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.