NCI Clinical Trials Reporting Program CTRP User Meeting May 4, 2011

Status update CTRO Metrics March Review CTRP 3.4 New Features Demo CTRP 3.5 Upcoming Release Summary CTRP Website Revision CTRP Registration Webinar Agenda

CTRO Metrics Metrics for March & April, Original submissions310 -Amendments44 Metrics January 2009 to date -Original Submissions3752 -Accepted3368 -Abstracted3169 -Submitted amendments351

March review User call – March 2 nd Minutes: CTRP+Site+Minuteshttps://wiki.nci.nih.gov/display/CTRP/ CTRP+Site+Minutes CTRO submitted questions/comments Registration timeline (observational trials) CTEP/DCP trial registration in CTRP

Overview of CTRP v 3.4 May 4, 2011

Software Upgrade Schedule OUR PLAN CALLS FOR UPGRADES APPROXIMATELY EVERY 3 MONTHS DATE – VERSION # STATUS April 2011 – CTRP 3.4 Released July 2011 – CTRP 3.5 In Progress September 2011 – CTRP 3.6 Planned DATEVERSION #STATUS April 2011CTRP 3.4Released July 2011CTRP 3.5In Progress September 2011CTRP 3.6Planned

More Information on our Releases View information about current and planned releases on the CTRP Development Team Wiki: ials+Reporting+Program+%28CTRP% Development+Project+Wiki

ENHANCEMENTS TO CTRP REGISTRY APPLICATION New in CTRP 3.4

Export Search Results Search results in CTRP Registry can now be exported for offline review or analysis Results can be exported as either o Excel (.XLS) file o Comma Separated Value (.CSV) file This new feature works for – Search All Trials, – Search My Trials, – Search Saved Drafts Enhancements to Registry Application in CTRP 3.4

Documents Saved with Drafts In Registry, the Save as Draft feature now allows you to save trial-related documents (for example, protocol document, IRB Approval) along with draft. Enhancements to Registry Application in CTRP 3.4

Trial Ownership Management Added some tools in Registry to make it easier to view and manage Trial Record Owners o Select Number of Trials to Display on a Page. You now have control over how the trial ownership screen displays. Select View Pagination to see a limited number of records per page, or View All to see an entire list of records that you can scroll through. o View Organizations by Lead Org ID. You can now sort the list of organizations on the trial ownership screen by Lead Org ID as well as NCI Identifier. In ADDITION... New tools added to applications that CTRO team uses to give that team greater flexibility and control over trial record owners. Enhancements to Registry Application in CTRP 3.4

Changes to Help Field Level Help, Online Help, and User's Guides are all now maintained on our wiki. Allows us to update the text for the Help or Guides WHEN NEEDED and AS OFTEN AS WE WISH. Updates to Help no long dependent on software release schedule. Now that it's on Wiki, the Users Guide is easier to access, navigate, read. But can still be downloaded as a PDF, if desired. Enhancements to Registry Application in CTRP 3.4

OTHER ENHANCEMENTS New in CTRP 3.4

Organization Families Feature added to back end systems and tools to allow CTRO to create Organization Families and to roll up organizations for more flexible data entry and reporting. CTRO will be creating these Organization Families over the next several weeks. We will expose aspects of this new feature in the Registry in future releases – 3.5 and 3.6. Key Improvements to Back-End in CTRP 3.4

Family Name: Albert Einstein Cancer Center Solid Line: Functional Type = Org; Hierarchy type = Peer/Parent/Child Dashed Line: Functional Type = Contract; Hierarchy type = Peer Dotted Line: Functional Type = Affiliate; Hierarchy type = Peer Albert Einstein Cancer Center Albert Einstein College of Medicine (ctepid NY043 /poid ) Montefiore Medical Center (ctepid NY045 /poid ) Jacobi Hospital (ctepid NY042 /poid ) Montefiore Medical Center Phase 2 Consortium (ctepid MMC /poid ) Montefiore Medical Center-Weiler Division (ctepid NY313 /poid ) Gynecologic Oncology Group (ctepid GOG /poid 88642) Eastern Cooperative Oncology Group (ctepid ECOG /poid 68593) The North Division of Montefiore Medical Center (ctepid NY179 /poid ) Example 1 of Organization Family Family Name: Albert Einstein Cancer Center Solid Line: Functional Type = Org; Hierarchy type = Peer/Parent/Child Dashed Line: Functional Type = Contract; Hierarchy type = Peer Dotted Line: Functional Type = Affiliate; Hierarchy type = Peer

NCI CTRP Registration

Biomarkers As part of its protocol abstraction process, CTRO is now able to record information in CTRP about study biomarkers, their classification, and purpose. Key Improvements to Back-End in CTRP 3.4

Example: Marker Abstraction Page

Anatomic Site CTRO is now able to capture Anatomic Site in CTRP as part of protocol abstraction. Added to support Summary 4 report functionality that is being implemented and that will be rolled out in a future release. Key Improvements to Back-End in CTRP 3.4

Example: Anatomic Site Selection

Accruals – Batch Upload Interface Batch upload interface for Accruals has been added based largely on CDUS abbreviated data set. Will be used internally for the present time for uploading accrual data from CTEP and DCP trials into CTRP. Plans for releasing this to wider community and for providing a services interface are under way but still not finalized. Specification document covering Accruals (file format, data elements, valid values) is available for review. Key Improvements to Back-End in CTRP 3.4

Integration with NCI Systems Significant work completed in as part of an on-going effort -- to tighten integration with other key NCI systems to help reduce duplicate manual data entry across systems and to improve data accuracy and completeness in CTRP. 1.PDQ (Cancer.gov) –> CTRP o Support added to back-end tools in CTRP to allow us to import trial data from PDQ into CTRP. o We are using this to load CTEP and DCP sponsored trials into CTRP. 2.RSS –> CTRP o Support added to back-end tools to allow Clinical Trial Support Unit (CTSU) Regulatory Support System (RSS) to feed CTRP with participating site data for CTEP and DCP sponsored cooperative trials (updates on daily basis). 3.CTRP –> PDQ (Cancer.gov) o Trial data from CTRP to be shared with PDQ on a nightly basis. Key Improvements to Back-End in CTRP 3.4

For More on 3.4 Release Notes for 3.4 are available on wiki: %28Summary+Version%29 User's Guide: ng+Program+Registration+Site+3.4+User%27s+Guide

CTRP Registration Webinar Online walk thru of the CTRP Registration process Individual or group settings New user or follow-up training Schedule flexibility -meeting requests or questions can be sent to

CTRP User Resources CTRP User meeting minutes: CTRP informational website: -Resources include FAQs, Glossary, and a CTRP User’s Guide CTRP Forum: kc.nci.nih.gov/CTMS/forums/viewforum.php?f=31https://cabig- kc.nci.nih.gov/CTMS/forums/viewforum.php?f=31 -Ask questions of the CTRP team and other CTRP users CTRP Developers’ wiki: wiki: – CTRP Users Manage your own subscription: bin/wa.exe?SUBED1=CTRP-USERS-L&A=1https://list.nih.gov/cgi- bin/wa.exe?SUBED1=CTRP-USERS-L&A=1 – All