1. NCI Clinical Trials Reporting Program CTRP User Meeting October 6, 2010

2. Agenda Status update and CTRO metrics CTRP 3.2 feature review CTRP 3.3 feature preview and future plans Key issues Open forum

3. Informatics Technology and Adoption Timeline Pilot Cancer Centers: –Accruals Pilot (Jan 2010 – Apr 2010) –Pilot: AEs, Outcomes, Non-interventional, etc. (Jun 2011 and ongoing) All Cancer Centers –New and existing trials, amendments (Jan 2010 – Nov 2010) –Ongoing Registrations (Nov 2010 and ongoing) –Accruals (Mar 2011 and ongoing) –3 rd Q-AE’s, Outcomes, Non-interventional, etc. (Jul 2011 and ongoing) All grantees –New and existing trials, amendments (Nov 2010 – Jun 2011) –Ongoing registration (Jun 2011 and ongoing) January 2010 October 2010 January 2011 July 2010 June 2011 Pilot Cancer Centers New and existing trials, amendments All Cancer Centers New and existing trials, amendments Accruals Pilot All Grantees Accruals 3 rd Q – AE’s, Outcomes, Non-interventional, etc. March 2011 September 2011 Ongoing Registrations Ongoing Registrations Pilot: AE’s, Outcomes, Non-interventional, etc.

4. Monthly Summary of Submissions

5. Clinical Trials Reporting Office (CTRO) Summary Metrics Metrics January 2009 to September 2010 –Original Submissions2776 –Accepted2512 –Abstracted2520 –QC1096 –Trial Summary Report Sent834 Abstraction Verified234 –Submitted amendments136

6. CTRO – Sample statistics 2,515 trials submitted –1,653 Proprietary submissions –862 Non-proprietary submissions 2,173 Trials abstracted –1,404 – proprietary –769 – non-proprietary Over 50 trials on hold, 171 rejected 697 Trials with TSR/XML sent –126 – proprietary –571 – non-proprietary 206 Trials that sites have provided feedback on –7% response rate for proprietary –25% response rate for non-proprietary

7. CTRO – Processing Time Validation performed same day as receipt Abstraction – within 10 business days –After a complete submission is received –During periods of higher volume, CTRO may prioritize workflow Prioritization of work –Non-proprietary w/o NCTID –Non-proprietary w/NCTID –Proprietary trials Amendments – within 3 business days

8. CTRO – Notes and Requests Our source of truth is the protocol document –Title, ID, and investigator verifications Changes to protocol content require an official, IRB approved amendment –Amendments and TSR feedback Amendments require a change memo/summary –Clean copy of protocol For questions about CTRO, rush requests and clarifications – contact NCICTRO@mail.nih.govNCICTRO@mail.nih.gov

9. CTRP 3.2 Review CTRP 3.2 features - August https://wiki.nci.nih.gov/display/CTRP/CTRP+3.2+Release+Notes –Organizational access –Security changes –TSR/XML On-demand –Optional XML/CT.gov fields –Add regulatory fields to the interface (already in the batch): Oversight Authority Name and Country, FDA Regulatory Information (Yes/No), Section 801 (Yes/No), Delayed Posting (Yes/No), Data Monitoring Committee Appointed (Yes/No) –Partial save Known issues: Missing acknowledgment email, Editable TSR

10. CTRP 3.3 Preview and future plans CTRP 3.3 planned features – November –https://wiki.nci.nih.gov/display/CTRP/Plans+for+CTRP+3.3https://wiki.nci.nih.gov/display/CTRP/Plans+for+CTRP+3.3 –Word/RTF TSR –Improved search –Move from proprietary/non-proprietary distinction to Summary 4 funding categories –Site portfolio review (pilot) –Timely update of CTEP and DCP trials –RSS integration for cooperative group trial participating site information –Trial status enhancements –CTRP information export to Cancer.gov

11. CTRP 2011 UI, batch, and service specifications for patient level accruals (based on CDUS Abbreviated) UI, batch, and service specifications for Adverse Events UI, batch, and service specifications for Outcomes Working with cancer community to align requirements from CDUS Complete, Basic Results Reporting, Patient Outcomes Data Specification Observational/Ancillary/Correlative studies Integration with CDMS program for accrual and outcome reporting

12. Key Issues Restructuring Person and Organization NCI Enterprise Services to model complex organization hierarchies and relationships Batch and service specifications for Accruals and Outcomes Information security specifications Summary 4 Funding (National, Peer-Reviewed, Institutional, Industrial) to replace proprietary/non-proprietary designated Meetings with NLM to align reporting between CTRP and ClinicalTrials.gov Improve communications to expand CTRP reporting of all NCI Supported Clinical Trials

13. Feedback venues National Cancer Advisory Board –Determined need for CTRP –High level monitoring of CTWG initiatives Clinical and Translational Research Advisory Committee (CTAC) –Advisory Committee on deployment of CTWG initiatives; meets quarterly caBIG ® Clinical Trials Management Systems Steering Committee –CTRP Strategic Subcommittee: conference calls bi-weekly on deployment strategy, reporting capability Site calls –Conference calls on operational issues

14. CTRP User Resources CTRP User meeting minutes: https://wiki.nci.nih.gov/display/CTRP/CTRP+User+Meetings https://wiki.nci.nih.gov/display/CTRP/CTRP+User+Meetings CTRP informational website: http://www.cancer.gov/ncictrp http://www.cancer.gov/ncictrp –Resources include FAQs, Glossary, and a CTRP User’s Guide CTRP Forum : https://cabig- kc.nci.nih.gov/CTMS/forums/viewforum.php?f=31 https://cabig- kc.nci.nih.gov/CTMS/forums/viewforum.php?f=31 –Ask questions of the CTRP team and other CTRP users CTRP Developers’ wiki: https://wiki.nci.nih.gov/display/CTRP’ wiki: https://wiki.nci.nih.gov/display/CTRP CTRP-USERS-L@list.nih.gov – CTRP Users ListservCTRP-USERS-L@list.nih.gov NCICTRP@mail.nih.gov – Program questionsNCICTRP@mail.nih.gov NCICTRO@mail.nih.gov – Clinical Trials Reporting OfficeNCICTRO@mail.nih.gov