NCI Clinical Trials Reporting Program (CTRP) Operational Reviews September 24, 2008

1 Agenda Production Release 1 Development Summary 4 CT.gov Production Website Milestones and associated business rules Action Items (see attached MS Word Document) Pilot Operations Key Issues and Action Item review CTRO Update Applications Status Applications Support Report out September 22 Ops Review Summary, Decisions, and Actions

2 CTRP Reporting for Clinical Trials.gov CTRP will have the capability to collect CT.gov data in January 2009 At this time, CTRP will not post to CT.gov for January 2009 Therefore, Clinical Trials Portal (registration) will NOT include questions regarding submittal to CT.gov. (e.g., Does site x want CTRP to report to CT.gov on their behalf) Task Force must continue to define requirements for future releases

3 CTRP Full Production Issues Full Production Website Proposal Cancer.gov/ncictrp continues to be primary public website and provide high level summary and policy content which does not change frequently Pilot website (ctrp.nci.nih.gov) is meant to support and therefore requires frequent updates/maintenance (e.g., What’s New, FAQs, Glossary, etc.). The proposal is to transition this site to Full Production Home page (current/existing pilot page) is “retooled” to be focused on Full Production Pilot site is created (behind the home page) and pulls pilot specific content from new Full Production Home page CTRO page continues as is Existing processes for updating/maintaining content continues for January CTRP PM/CTRO, in coordination with OCE, maintain content and design changes CBIIT Web developers post updates and implement design changes

4 Milestones and associated Business Rules Corresponding Milestones (Production) Processing Status (workflow status) Business Rules Submission received Datesubmitted Submission Acceptance Dateaccepted Submission Rejection Daterejected Ready for QC Dateaccepted QC start dateaccepted QC completed dateabstracted Trial Summary Report Sent Dateabstracted Submitter Trial Summary Report Feedback Date (conditional/ as needed) abstracted Initial Abstraction Verified Dateabstracted-verified Initial Submission to CT.GOV Dateabstracted-verified On-going Abstraction Verification Dateabstracted-verified

5 Agenda Production Release 1 Development Summary 4 CT.gov Production Website Milestones and associated business rules Industry Trials Action Items (see attached MS Word Document) Pilot Operations Key Issues and Action Item review CTRO Update Applications Status Applications Support Report out September 22 Ops Review Summary, Decisions, and Actions

6 Pilot Update Phase 1 pilot Updates provided to the sites Manual registration of trials has stopped. Please do not register any more trials. Hold until Phase 2 (batch preferably) Each site should be receiving Trial Summary Reports Accrual deadline for Phase 1 is extended to October 17 Accrual training scheduled for week of Sep 29 Phase 2 Pilot Updates provided to the sites Submitter will be required to approve each Trial Summary Report starting in Phase 2 of pilot Batch Capability targeted for mid-October Steering Committee Presentation minutes and Weekly Pilot Site Call Meeting Summaries have been posted to gforge _id=3949&language_id=1https://gforge.nci.nih.gov/docman/index.php?group_id=456&selected_doc_group _id=3949&language_id=1

7 Applications Update -- Engineering Report for Pilot Phase /24 * - denotes need to discuss business process dependency Operational Requests Total Closed 20 Open EW#41120/CTRO Staff: Protocol #: NCI , corrections needed EW#42325/CTRP: Many PI s not on list Another missing PI--Suzy Torti (NCI ) Missing PI in CDS PA--Gretchen L. Wells needs to be added Defects Total Closed 108 Total Open 21 Total Priority Open5 P Session time out when registering a Trial Update End User documentation with change in viewing submitted trials Duplicates in Principal Investigator list TM is not removed from CACTUS Home page, Add a Trial page and help file (Related to FR 15172) Add new MS word file types for upload -- old:Incorrect error message when user uploads unsupported file type PI name is in CTEP systems but not in CDS PA HTTP 500 on disease list action suspected duplicate org and error with pi Abstraction Status is not shown in view or edit screen once record is updated successfully Coding letter - intervention not showing up Problems accessing the second page of diseases System Error message is missing application support information; also revised text of message

8 Applications Update -- Engineering Report for Pilot Phase /17 (continued) * - denotes need to discuss business process dependency Features Total Closed 114 Total Open 17 Priority Open2 P It's not clear what selection to make in the NCI Division/Program field Can we support other versions of Word documents on document upload? Provide a way to delete an Intervention or Disease once it's been added to the system Need to be able to edit a submission after validation and approval List of Principal Investigators should be sorted alphabetically Restrict organization list to only those that are appropriate in registration portal #41001/CTRO STAFF: Protocol # NCI , corrections needed & access issues

9 Applications Update -- Engineering Report for Pilot Phase /22 (continued) * - denotes need to discuss business process dependency Features Provide edit capability on the grant information on the Protocol Details screen Don't require that Diseases be selected Don't require that Interventions be selected Don't require that IND be selected from a list Provide ability to track milestones Add 'Planned Accrual' fields The Submitter field should be a mandatory field Don't allow duplicate accepts of a trial within the cactus UI Add constraints to CDS components that disallow creation of records with duplicate NCI trial ids remove links in cds-web Some fields are missing the 'required field' indicator (which is boldface for the label)

10 CTRO Update 67 Trials submitted; 13 Trials ( 7 Dana Farber, 3 Northwestern, 3 Wake Forest) Week of Sep Source 44 Wake Forest 7 Mayo Clinic 6 St. Jude 7 Dana Farber 3 Northwestern Status 66 Accepted (1 On hold) 0 – Under abstraction 59 – Completed QC 3 – Pending QC 4 - Pending App Support (deletion of terms or error messages) 51 Total Summary Letters Submitted (15 Summary letters submitted last week) Topics for discussion Should waiver consent be stated in the IRB Date Summary Letters/Pilot II will be sent

11 Applications Support Update 125 Total tickets (as of 9/22) 10 last week By Status 13 are open 112 are closed By Type 25 tickets are password and login 10 are systems, deployment/stage, data 38 are feature requests / enhancements 18 error message related 1 performance 33 feedback, how to or policy questions By Site Majority from CTRO With questions from Northwestern, and Dana Farber.

12 Applications Support Update Cont. 13 Open tickets (as of 9/22) By Type 5 are Account/Passwords 6 are feedback, how to or policy questions 1 are Error related 1 are Reports By Number of Days Open 4 are 1-7 days (2 Accrual Accounts, and How-to Questions) 2 are 8-15 days (1 Grant Information, 1 Abstraction Status) 7 are 15+ days 2 related to Industry Trials (initial questions posed by Mayo and Wake Forest) 3 related to request for accrual accounts from the sites

13 Applications Support (continued)

14 Agenda Production Release 1 Development Summary 4 CT.gov Production Website Industry Trials Milestones and associated business rules Responsible party Action Items (see attached MS Word Document) Pilot Operations Key Issues and Action Item review CTRO Update Applications Status Applications Support Report out September 22 Ops Review Summary, Decisions, and Actions

15 Sep 24 Ops Review Meeting Summary T. Budd (DCP) L. Grama (PDQ) S. Friedman (CTEP) XB. Meadows (DCP) XJ. Speakman (CBIIT) P. Winkler (Centers Br) R. Dejoice (OCE) A. Ousley (OCE) J.Zujewski (CTEP X K. Stern (BAH) XR. Teague (BAH) XK. Eckley (CTRO) XB. Colchagoff XA. HenryXS. Whitley (TerpSys) X C. Andonyadis (CBIIT) XA.Basu (CBIIT) E.MulaireXS. Hastak (ScenPro) N.Shimko (ScenPro) Attendees: XP Attended MeetingAttended by PhoneDid not Attend 1.Summary 4: Task Force reviewed and reconciled the outstanding data elements (Trial Type and Phase) Trial Type will be captured in Abstraction based on registration of Study Type Study Type: 1)Treatment 2)Prevention 3)Supportive Care 4)Screening 5)Early Detection 6)Diagnostic 7)Epidemiologic 8)Outcome 9)Observational 10)Ancillary 11)Correlative 12)Health Service Res. 13)Other Phase:0, 1, 1/2, 2, 2/3, 3, 4, pilot, N/A 2.CT.gov – Task Force agreed with approach outlined on page 2 for the January release 3.Production Website: Task Force agreed with approach outlined on page 3 for the January release 4.Pilot Phase 2 Proposal Sites will be allowed to register trials and report accrual data through manual processes if that is preferred Sites will be asked to submit approximately 10 trials per batch upload on a monthly basis Key Discussions and Decisions:

16 September 27 Action Items Action Items: DateDescriptionResponsible Party Completed?Issue Tracking Report 8/27/08Provide feedback to Kevin or Rebecca about the January Operations Deployment Plan and related Program Plan CTRP Task ForceCompleted 8/27/08Review and provide clarify the definition of “IRB approved”Teague/Grama 8/27/08Correct Org Trial Identifier term in acronyms and glossary sections on the CTRP web site Stern/R.BuddIn progress 8/27/08Look at program codes with developersTeague/ Colchagoff Completed 8/27/08Review requirements to integrate CTRP with Impact 2 extension (I2E)Hastak 8/27/08Provide spreadsheet form RDX6 white paper for potential reports requirements HastakIn progress, still need spreadsheet 9/3Coordinate with Impact 2 extension team to set time for a demoA.HenryIn progress 9/3Develop worklfow for Trial Summary Report / Accrual reporting for Phase 2 Teague/ Eckley/ Whitley In progress Incorporate outstanding Mond Dev Action Items

17 September 27 Action Items Action Items: DateDescriptionResponsible Party Completed?Issue Tracking Report 9/17/08Send action item list from the Monday pilot site meeting to Buff.RebeccaCompleted 9/17/08Work on answering St. Jude’s questions and circle back with Task Force. Amy, Stephanie, Rebecca Completed 9/17/08Schedule training sessions with pilot centers.StephanieIn progress 9/17/08Create a subset of trials from the ones Wake Forest submitted and let them choose less than 10 to submit accrual data for. Kim, Rebecca, Travis In progress 9/17/08Touch base with Donna about adding/requesting PI’s to list.BuffCompleted 9/17/08Work on a process to alert Travis for when a “one off” accrual POC has been submitted on an accrual data form. Engineering TeamIn progress 9/27Develop Business rules for the Milestones in PATeague/ Grama/ Budd In progress 9/27Steve will work with CTEP and Rebecca to develop a solution to add additional PIs Friedman/TeagueCompleted

18 Pilot Monday Site Conf Call Actions DescriptionResponsible PartyCompleted?Internal/External Capture Industry trials questions and key comments for sites to share with their legal staff R.TeagueInitial discussion conducted on 9/29 Review the definition of “Approved” for Trial Status and refine if needed CTRP Task ForceNo Search for a use example trial where there are multiple NCI grants and therefore multiple NCI program codes. Ramin of St. JudeIn progress Establish a CDS-Web and NCI VPN accounts by contacting NCICB Applications Support, referencing the CTRP Project Site CoordinatorsIn progress Will the pilot data be migrated in January? Pilot Sites to review initial Industry trial document and provide comments to CTRP Task Force Accrual reporting – define who withi NCI will have access and what data will be available