18-sept-2008open conference open implementation in the protocol lifecycle martha hering, rn ccrp...

18-Sept-2008 OPEN Conference

OPEN Implementation in the Protocol Lifecycle

Martha Hering, RN CCRP

CTSU Operations Manager

CTSU OPEN Conference


Agenda • Protocols in OPEN• Study Initiation Process and OPEN

– Define Group Roles – Protocol and Eligibility Checklist Preparation – Eligibility Checklist Submission

• Protocol Setup in RSS• Eligibility Checklist Setup in OPEN• Study Conduct and OPEN

– Amendment Updates and EC Changes– Overrides– Data Updates– Integration

• Protocol Closures and Suspensions


So how do I add a protocol to OPEN?


Protocols in OPEN• The initial protocol in OPEN for a Cooperative

Group is selected by the Group.– The Group and CTSU work closely to develop the

Randomization Node • The link between OPEN and the Group randomization

system

– The Group and CTSU work closely to develop the initial Eligibility Checklist (EC) in OPEN.

– The Group will communicate patient enrollment requirements to CTSU.

– The Group will define roles to support OPEN. – The Group will work with CTSU to update the

Group rosters in RSS.


Protocols in OPEN (cont.)

• Subsequent Protocol– After the initial Group protocol is in OPEN,

all newly activated trials will be in OPEN.

– Legacy trial migration to OPEN will be decided based upon current accrual, upcoming amendments, etc.


Study Initiation – Step 1Define Roles

• Define roles and responsibilities at the Group– Who develops Eligibility Checklist

– Who writes edits for the EC

– Submits for CDE review and loads the EC to caDSR

– Who works with the CTSU OPEN Admistrator to test EC and edit checks

– Who gives final sign-off prior for production

– Who is your OPEN Administrator(s)• Submits request, override administration


Study Initiation – Step 2Prepare

• Prepare Protocol– Prepare instructions for using OPEN

• CTSU Protocol Specialist will provide template language

– CTSU and the Group will work with PIO to handle OPEN as an administrative change for previously approved protocols.

• Prepare the Eligibility Checklist– Develop CDE compliant EC

– Begin drafting edit specifications


Study Initiation – Step 2Prepare (cont.)

• Why does the EC need to be CDE Compliant caDSR? – One of the goals of OPEN is to develop a caBIG

compatible application to enhance collaboration and additional system integration. • OPEN will ultimately be caBIG compatible at the silver

level.

– Development of CDEs for eligibility criteria is a long-term goal at CTEP.


Study Initiation – Step 2Prepare (cont.)

• Scope of CDEs in OPEN– All ECs in the OPEN system will be CDE

compliant and loaded to the caDSR regardless of phase, disease area or type (treatment/prevention) without exception.

– Modifications to the EC that involve collection of new data or deletion of data will require CDE review (new data) and resubmission of the EC to caDSR*


Hint

Use the CDE Browser to assist in selecting data elements that are already CDE compliant when

developing the EC.


Study Initiation – Step 3Submit and Load

• CDE Review and Submission Process – CRFs are submitted for CDE review at time of

protocol submission to PIO

– EMMES completes review of CRF and returns:

• Match

• Recommend use of existing term

• Create new CDE

– Iterative process between the Group and EMMES


Study Initiation – Step 3Submit and Load (cont.)

• Recommended timeframes for Submission– For new phase 3 studies include the EC in the

CRF submission packet to EMMES.

– For studies that do not require CDE compliant CRFs submit the EC at the time of protocol submission to PIO or shortly thereafter.

– For phase 3 studies currently open, submit the EC for CDE review as soon as the study is identified for OPEN taking into consideration any pending amendments that may effect the form.


Study Initiation – Step 3 Submit and Load (cont.)

• Load CDE compliant EC to caDSR– Notify CTSU OPEN Administrator that EC

has been loaded.

• Complete edit specifications


Protocol Setup in RSS


Protocol Setup

• The correct setup of all protocols in RSS is essential for the collection of regulatory documentation, OPEN functionality, and applying correct crediting and financial information to each enrollment.


Protocol Setup (cont.)

• The RSS Protocol Screen will drive OPEN! – Protocols screens must be maintained in real time

to provide sites accurate information. • approval/activation

• amendment/updates

• study closure

• CTSU will support the Groups in setting up the initial protocols in RSS for OPEN.– Updated Protocol Screens are scheduled for

release in October.

– Time for the screen by screen tour


Protocol Main Screen Setup

• The Main Screen has been modified to better support OPEN

• The assigned Group staff person will complete all required fields

• Group Protocol Status • CB review – tracking of continuing renewals

after study closure to accrual• Date and Time – time stamp will now be

critical for protocols that are closing to accrual at a specific time.


Expanded section for CTSU menu

and OPEN

Increased summary information on main screen.

Plans to integrate status

with PIO.

PROTOCOL MAIN SCREEN& did you notice the

screens are Bigger !!


Currently there are no changes to this screen, but with OPEN it will be more critical to track all protocol versions and not just versions that

require collection of regulatory documentation.

PROTOCOL VERSION SCREEN

There are plans to simplify the version categories to designate if the collection of approvals is required, and if the review must be

full board or if expedited review accepted.


No changes to this screen at this

time.

PROTOCOL SPECIFIC REQUIREMENTS

Important Reminder:Please contact the CTSU Regulatory Office and/or Operations Office when setting up

protocol amendments with mandatory collection or protocols with multiple or complex

requirements.


Logistics Screen• NEW SCREEN TO SUPPORT OPEN• Supports implementation of Endorsement

Plus• Supports more granular participation

requirements – i.e. limited participation protocols

• Supports multi step protocols• Supports requirements for collection of

person information at the enrollment level in OPEN


PROTOCOL LOGISTICS SCREEN

Enter steps for registration. Collection of treating

investigator will be the default

Limit participation by organization and/or

site.


NEW FEATURE - Document all payments and track payments per

arm.

FUNDING SCREENSCurrently used for CTSU menu studies, but major changes are

planned to better support tracking of ancillary studies and all funds.


Registration and Eligibility Checklist Set Up in OPEN

Diana Meyer

OPEN Administrator


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


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


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


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.


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.


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.


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.


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


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


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.


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.


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


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.


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.


Study Conduct in OPEN


How will OPEN impact the conduct of my study?

• OPEN will change the systems and modify some of your the current procedures for the following tasks:– Updates to the Eligibility Checklist– Overrides– Data Updates and Patient Transfers – Integration with other systems– I.E. - These tasks are not new but where and how

they are completed will change.


Study Conduct – EC Update Process

• Eligibility Checklist Update Process– Two Time Periods

• With study update/amendment

• Outside of study update/amendment

– Types of Change• Addition of Questions (requires CDE review)

• Changes to Edits

• Changes to Formatting

• Deletion of Questions (requires load to caDSR)


EC Update Process (cont.)

• Determine Type of Update

• If required submit amended EC to EMMES for CDE review – Currently the EC will need to be reloaded

to caDSR for changes to the CDE

– Submit the EC at the time the updated CRFs and protocol are submitted to PIO for review if applicable.



• Submit the OPEN Request Form to the CTSU OPEN Administrator– Acknowledgement within 1 business day

– Time of Need • Submit form

• Call OPEN Administrator or their designee

• Acknowledgement in 2 hours


General information

Request will include copy of EC

with layout and Edit Spec. sheet



• Loading and Testing

– If applicable, the CTSU OPEN Administrator will download the form from caDSR.

– The CTSU OPEN Administrator will update the form layout.

– If applicable, testing of metadata and clinical data will occur

• Changes to previous CDE

• Deletion of questions

• Testing must be completed prior to next step



• Edit check update– The OPEN Administrator generates edit

checks from statements given by the lead protocol group.

– Internal testing of edit checks is completed• Multistep process that will be documented

– Form is submitted to Group for final testing

– Once approved, updated form is moved to production into OPEN



• Timelines for updates– Are dependent on a number of factors

• Type and extent of change

• Timeframe in which the change needs to be made

• Organizations involved– Group, CTSU, EMMES, others?

• CTSU will work with the groups to meet expedited timeframes.



• CTSU will set up the initial protocol checklist in OPEN. For subsequent protocols this task will be moved to the Cooperative Groups in a staggered fashion after appropriate training and modification of the current draft procedure.


Study Conduct – Override Process

• The Group and CTSU Open Administrators will have access to the Override screens.

• The Group will determine which fields can be overridden as part of the initial EC setup.

• Only the Group OPEN Administrator can grant an override for clinical evaluations

• Preapproval of overrides will be tracked in OPEN for common acceptable overrides. (next release)


Override Process (cont.)

• Site submits an override request via OPEN

• Site receives acknowledgement of request– Overrides processed per the lead Group’s

guidelines

– Registration kept for 5 days

– Tracking number for the override is assigned



• The Group and CTSU OPEN Administrator receive an e-mail notification for an override request.

• The Group OA access the Override Screen in OPEN, and selects the appropriate ticket number to process the override.


Select “edit”


Enter OR code

Enter Status

Enter comment



• E-mail submitted to the site regarding the outcome of the request– Approved – registration will be resubmitted

with override code

– Disapproved – registration cannot be resubmitted unless data is updated

– On-hold – data cannot be changed until the override is processed.


Study Conduct – Data Updates

• Data changes will not be made in OPEN

• Changes to the logistical data will be made in the RSS Patient Enrollment Crediting (PEC) screens– Investigator, Credited Group, Site Code

• Updates will be e-mailed to the lead protocol group and available through RDTS

• Changes to the EC data will be made via the lead protocol Group’s systems.


Data Updates (cont.)

• Patient Transfers– Documented per current CTSU Procedures

• Receiving sites have regulatory approval

• Receiving investigators are active with CTEP and on a CG treatment roster

• All data at the originating site has been submitted and queries are resolved

– Tracked in the RSS PEC screens

– Reports of all transfers are available in RSS.


Study Conduct – OPEN Integration• OPEN integration with RSS

– Protocol Data– Regulatory Data– Institutional and Person roster data– Patient enrollment data (registration changes/transfers)

• OPEN integration with Financial Management System– Payment processing for non-lead group sites

• OPEN integration with clinical database– CTSU CSP studies in Oracle Clinical– Group Clinical databases?

• OPEN Data Availability– Randonode– CTSU Enterprise Web Service (CEWS) – RDTS


Protocol Closure


Protocol Closure

• Temporary Suspensions and Emergency Closures– The process of CTSU working with the

Groups to announce temporary protocol suspensions and closures will not change.

– Managed from RSS Protocol Set Up screen using Group date and time flag.

– Notifications can be posted on the OPEN Home Page


What’s Next?


Expanding Capabilities

• Support of more complex registration designs

• More override functionality

• Expanded audit/history tables to track data updates

• Integration– Increased with Financial Management

– RDE support

– CDUS reporting

18-sept-2008open conference open implementation in the protocol lifecycle martha hering, rn ccrp...

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