registration and eligibility checklist set up in open diana meyer open administrator
DESCRIPTION
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 RSSTRANSCRIPT
Registration and Eligibility Checklist Set Up in OPEN
Diana MeyerOPEN Administrator
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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
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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
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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
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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.
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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.
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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.
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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.
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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
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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
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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.
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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.
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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
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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.
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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.