1. 18-Sept-2008OPEN Conference OPEN Implementation in the Protocol Lifecycle Martha Hering, RN CCRP CTSU Operations Manager CTSU OPEN Conference

2. 18-Sept-2008OPEN 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

3. 18-Sept-2008OPEN Conference So how do I add a protocol to OPEN?

4. 18-Sept-2008OPEN Conference 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.

5. 18-Sept-2008OPEN Conference 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.

6. 18-Sept-2008OPEN Conference Study Initiation – Step 1 Define 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

7. 18-Sept-2008OPEN Conference Study Initiation – Step 2 Prepare 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

8. 18-Sept-2008OPEN Conference Study Initiation – Step 2 Prepare (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.

9. 18-Sept-2008OPEN Conference Study Initiation – Step 2 Prepare (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*

10. 18-Sept-2008OPEN Conference Hint Use the CDE Browser to assist in selecting data elements that are already CDE compliant when developing the EC.

11. 18-Sept-2008OPEN Conference Study Initiation – Step 3 Submit 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

12. 18-Sept-2008OPEN Conference Study Initiation – Step 3 Submit 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.

13. 18-Sept-2008OPEN Conference 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

14. 18-Sept-2008OPEN Conference Protocol Setup in RSS

15. 18-Sept-2008OPEN Conference 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.

16. 18-Sept-2008OPEN Conference 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

17. 18-Sept-2008OPEN Conference 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.

18. 18-Sept-2008OPEN Conference 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 !!

19. 18-Sept-2008OPEN Conference 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.

20. 18-Sept-2008OPEN Conference 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.

21. 18-Sept-2008OPEN Conference 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

22. 18-Sept-2008OPEN Conference PROTOCOL LOGISTICS SCREEN Enter steps for registration. Collection of treating investigator will be the default Limit participation by organization and/or site.

23. 18-Sept-2008OPEN Conference NEW FEATURE - Document all payments and track payments per arm. FUNDING SCREENS Currently used for CTSU menu studies, but major changes are planned to better support tracking of ancillary studies and all funds.

24. 18-Sept-2008OPEN Conference Registration and Eligibility Checklist Set Up in OPEN Diana Meyer OPEN Administrator

25. 18-Sept-2008OPEN Conference 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

26. 18-Sept-2008OPEN Conference 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

27. 18-Sept-2008OPEN Conference 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

28. 18-Sept-2008OPEN Conference 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.

29. 18-Sept-2008OPEN Conference 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.

30. 18-Sept-2008OPEN Conference 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.

31. 18-Sept-2008OPEN Conference 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.

32. 18-Sept-2008OPEN Conference 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

33. 18-Sept-2008OPEN Conference 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

34. 18-Sept-2008OPEN Conference 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.

35. 18-Sept-2008OPEN Conference 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.

36. 18-Sept-2008OPEN Conference 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

37. 18-Sept-2008OPEN Conference 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.

38. 18-Sept-2008OPEN Conference 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.

39. 18-Sept-2008OPEN Conference Study Conduct in OPEN

40. 18-Sept-2008OPEN Conference 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.

41. 18-Sept-2008OPEN Conference 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)

42. 18-Sept-2008OPEN Conference

43. 18-Sept-2008OPEN Conference 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.

44. 18-Sept-2008OPEN Conference EC Update Process (cont.) 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

45. 18-Sept-2008OPEN Conference General information Request will include copy of EC with layout and Edit Spec. sheet

46. 18-Sept-2008OPEN Conference EC Update Process (cont.) 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

47. 18-Sept-2008OPEN Conference EC Update Process (cont.) 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

48. 18-Sept-2008OPEN Conference EC Update Process (cont.) 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.

49. 18-Sept-2008OPEN Conference EC Update Process (cont.) 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.

50. 18-Sept-2008OPEN Conference 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)

51. 18-Sept-2008OPEN Conference 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

52. 18-Sept-2008OPEN Conference Override Process (cont.) 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.

53. 18-Sept-2008OPEN Conference Select “edit”

54. 18-Sept-2008OPEN Conference Enter OR code Enter Status Enter comment

55. 18-Sept-2008OPEN Conference Override Process (cont.) 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.

56. 18-Sept-2008OPEN Conference 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.

57. 18-Sept-2008OPEN Conference 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.

58. 18-Sept-2008OPEN Conference 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

59. 18-Sept-2008OPEN Conference Protocol Closure

60. 18-Sept-2008OPEN Conference 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

61. 18-Sept-2008OPEN Conference What’s Next?

62. 18-Sept-2008OPEN Conference 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