NCI Clinical Trials Reporting Program CTRP User Meeting February 9, 2011

Team Introductions Status update – Focus groups and 3.4 plans Follow-up from January Recent Questions Open forum Agenda

CTRP Project Director – Gene Kraus Acting Program Manager – Joe Martucci Interim Medical Director – Gisele Sarosy, M.D. Software Project Manager – Edmond Mulaire CTRO Manager – Kimberly Eckley Operations Support Supervisor – Andrea Jackson Lead Analysts – Charles Yaghmour and Paul Davis Development team lead – Steve Lustbader Team

CTRP Focus Groups Message from Charles Yaghmour, 2/4/2011 Six focus groups covering the following CTRP areas: -Trial Registration and Amendments -Accruals -Organizations Structure -User Interface -Reporting -NES Services The first two meetings will be for the “Accruals” and “ Organizations Structure” focus groups. Invitations have been sent.

CTRP 3.4 Plans 3.4https://wiki.nci.nih.gov/display/CTRP/Plans+for+CTRP+ 3.4 Organization management improvements (roll-up) ClinicalTrials.gov XML improvements Enhancements to trial registration service Accruals Biomarker abstraction Improvements to Trial Ownership and Organizational Access Download search results Save documents in “Partial Save”

January meeting follow-up Request – Search for all trials associated with an organization Question – Will studies closed prior to January 1, 2009 be accepted? Trials are only accepted if they were open as of January 1, Special cases may be submitted to the CTRO for review with CTRP leadership. Question – If the IRB approval letter is not available, is there anything else that can be used? At a minimum, the IRB Approval Number and IRB Name is required for registration. The date of IRB approval may be used in place of the Approval Number.

CTRP Trial Status –ClinicalTrials.gov Trial Recruitment Status –Description In Review –Not yet recruiting –Trial is currently under IRB review Approved –Not yet recruiting –Trial has been approved Disapproved –Withdrawn –IRB has rejected the trial Active –Recruiting –Trial is open for accrual Closed to Accrual –Active, Not recruiting –Trial has been closed to participant accrual. Participants are still receiving treatment/intervention. Closed to Accrual and Intervention –Active, Not recruiting –Trial has been closed to participant accrual. No participants are receiving treatment/intervention, but participants are still being followed according to primary objectives of the study. Temporarily Closed to Accrual –Suspended –Trial is temporarily not accruing Temporarily Closed to Accrual and Intervention –Suspended –Trial is temporarily not accruing. Participants are not receiving intervention. Withdrawn –Withdrawn –Trial as been withdrawn from development and review Administratively Complete –Completed –Trial has been completed prematurely (for example, due to poor accrual, insufficient drug supply, IND closure, etc.) Complete –Terminated –Trial has been closed to accrual; participants have completed treatment/intervention, and the study has met its primary objectives. January meeting follow-up – Complete trial status

Clinicaltrials.gov Trial Recruitment Status -Description Not yet recruiting -Participants are not yet being recruited or enrolled Recruiting -Participants are currently being recruited and enrolled Enrolling by invitation -Participants are being (or will be) selected from a predetermined population Active, Not recruiting -Study is on-going (i.e., patients are being treated or examined but enrollment has completed) Completed -Study has been concluded normally; patients are no longer being examined or treated (i.e., last patient’s visit has occurred) Suspended -Recruiting or enrolling participants has halted prematurely but potentially will resume. Terminated -Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated Withdrawn -Study halted prematurely, prior to enrollment of first participant January meeting follow-up – Participating site trial status

Recent questions Accruals – requirements Person and Organization duplicates Archived documents on closed studies Existing trial XML availability Investigator address as a required field, shows up in the XML

Accruals - *provisional, may change Frequency of reporting -Quarterly Method of reporting -Batch file via User Interface or via WebDav (http) integration Validation and error processing -Example: Incomplete or incorrect data Reporting policy -Institutional / Peer Reviewed Studies: Lead organization submits complete patient accrual demographic data -Industrial Studies: Each participating site submits aggregate patient accrual count for their own site -National Studies: DCP/CTEP Studies: DCP/CTEP to submit accrual data to CTRP via CDUS Complete or Abbreviated file format Non-DCP/CTEP Studies: Lead organization submits complete patient accrual demographic data

PATIENT DEMOGRAPHIC INFORMATION - Mandatory=M Optional=O NCI Protocol ID -M Total Patient Accrual Count, Only for Industrial studies -M/O Patient ID -M Patient Zip Code (Only first 5 digits) -M/O Patient Country Code; Mandatory for non-U.S. residents -M/O Patient Birth Date (Month/Year) -M Patient Gender -M Patient Ethnicity -M Patient Method of Payment -O Date of Patient Entry -M Patient Disease Code ( CTEP Simplified Disease Code list); Optional for Prevention Studies -M/O Patient Race -M PATIENT DEMOGRAPHIC INFORMATION* PATIENT DEMOGRAPHIC INFORMATION Mandatory=M Optional=O NCI Protocol IDM Total Patient Accrual Count Only for Industrial studiesM/O Patient IDM Patient Zip Code (Only first 5 digits)M/O Patient Country Code Mandatory for non-U.S. residentsM/O Patient Birth Date (Month/Year)M Patient GenderM Patient EthnicityM Patient Method of PaymentO Date of Patient EntryM Patient Disease Code ( CTEP Simplified Disease Code list) Optional for Prevention StudiesM/O Patient RaceM

CTRP Accrual Data Batch Load To-Be Process

Support model All questions, comments, support needs should go to the Clinical Trials Reporting Office, and will remain, but requests will be directed to the

CTRP User Resources – All 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 – All 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