1. CTRP User Call May 7, 2014 Gene Kraus CTRP Program Director

2. Agenda Welcome CTRP Topics -Registering trials with and without NCT# Adding participating site information -ICD-9 and ICD-10 codes -Trial data verification – every 6 months -Use change status in registry to correct status dates, during validation, and when viewing TSRs -Accrual reporting on industrial trials -Indicating NCI grant funding during registration; some centers are not entering the P30 when registering the trial in CTRP -CTRP outreach calls to NCI-Designated cancer centers Wrap-up

3. Trial Registration

4. Abbreviated Trial Submission Types Industrial; registered on ClinicalTrials.gov (with NCTID) -Center completes registration using NCTID -Centers need to follow up immediately with email to CTRO that includes: the site name, site PI and trial ID. -If no sites are listed when CTRO completes abstraction, the trial is placed on hold – unable to complete validation. -At any point you can send an email to CTRO to complete the abstraction. In a future release this process will be improved.

5. Other - Externally peer-reviewed; Other – National (Consortia Trials) (NCTID available) Current -Center registers the trial using the NCTID. -Centers need to follow up immediately with email to CTRO to include: the site name, site PI, Trial ID and Summary 4 Category. -CTRO will complete abstraction; correct Summary 4 Category during abstraction

6. Industrial, not registered on ClinicalTrials.gov (no NCTID) CTRO must register these trials Center submits their local ID and status information along with the protocol document (if possible). If the protocol document cannot be shared, center must complete the Submission Worksheet. Upon receipt, CTRO will register, then abstract the trial. Note: if you are expecting that this trial will be eventually registered in ClinicalTrials.gov, please register in CTRP after it is in ClinicalTrials.gov If you are using this workflow you should be prepared to verify the trial in CTRP every 6 months

7. Disease Codes in CTRP

8. Disease Codes At this time CTRP is accepting trials coded with: -CTEP SDC -ICD-9 -ICD-O-3 CTRP is preparing to accept trials in ICD-10 in the future Healthy / Normal Volunteers -ICD-O-3 Codes C998 Disease Not Specified 7001 histology code C999 Healthy Volunteer 7002 histology code -ICD9 Codes V99 Healthy Volunteer V100 Disease Not Specified -CTEP SDC 80000000 Healthy Volunteer 80000001 Disease Not Specified

9. Accrual Reporting on Industrial Trials Important Reminder

10. Accrual Report on Industrial Trials It is IMPORTANT that centers submit TOTAL (cumulative) accruals for Industrial trials -Incremental accruals will overwrite the previous accruals and the center may appear to have “negative” accruals. Incremental or Total Accruals can be submitted for Institutional trials.

11. Who is responsible for submitting accrual data for trials in CTRP? The Lead Organization/Coordinating Center is responsible for submitting accrual data for all patients enrolled on Institutional and Externally Peer-Reviewed trials in CTRP. Individual participating sites are responsible for submitting Summary Accrual on Industrial trials in CTRP. For NCI Managed trials e.g. National (Network) trials in CTRP, these data are transferred internally, i.e., directly from CTEP and DCP PIOs to CTRP.

12. Trial Data Verification

13. Reasons to Verify the CTRP Trial Registration Ensures the accuracy and currency of the CTRP trial registration record: -Status -Participating Sites -Clinical trial record reflects any amendments and updates since initial registration (e.g., changes in eligibility, treatment regimen, etc.) ClinicalTrials.gov requires that each record be updated twice each year. Those using the CTRP generated XML will have an updated file for ClinicalTrials.gov.

14. Trial Data Verification Trials must be reviewed for accuracy twice each year. -The date is calculated by last verification date Automated E-mail reminders are sent to trial owners, submitters and site administrators. -First email sent 30 day prior to due date -Second email sent 15 days prior to due date The ability to verify records is available to trial owners or submitters. Data verification is important both for CTRP and the submitting cancer center to ensure the accuracy of trial records.

15. Correcting Status and Status Date

16. Correct Status Date Issues During Verification Users should use change status in registry when: Correcting status dates, Verifying trial data, or When viewing TSR’s

17. Trial Verification – Status

18. TSR’s

19. TSRs Sent to Users - UPDATE It is possible that CTRP users may begin receiving more TSRs than in the past. -A TSR will now be sent when any change, however minor, is made to the TSR (e.g. correction of a typo). -This will allow trial owners to be aware of ANY changes made to their record in CTRP.

20. Defining NCI Supported

21. Cancer Center Trials - NCI Supported Remember, all trials taking place in an NCI Designated cancer center are considered to be NCI Supported, and, each trial should indicate the source of NCI support. -These trials may have specific funding, but, at the least, all should include the CCSG P-30 grant in the CTRP registration record.

22. CTRP Outreach Calls to the Cancer Centers

23. Outreach Calls – Data Table 4 Reviews The CTRP Program Director, in coordination with the Program Director from Office of Cancer Centers is currently reaching out to all NCI Designated Cancer Centers These calls are a “First Pass” at comparing the Data Table 4 information generated from CTRP with the data submitted by the Cancer Centers in their CCSG DT4 reports These calls generally last between 45-60 minutes Draft CTRP DT4 reports are shared with the Cancer Center following the call Centers are asked to review the questions that arise during the review of these draft reports and get back to the CTRP Program Director in 2 weeks with an update on their review of the data presented.

24. Outreach Calls Early results are very promising. -We have identified minor discrepancies between the CC DT4 reports reporting and the CTRP generated DT4 reports. Reasons include: -CTRP is still working on importing some remaining accrual data from CTEP systems for National trials -Trial Status and Status Dates (primarily Industrial trials) -Missing sites in the CTRP DT4 for some Industrial trials and from some multi-Institutional trials National trials.

25. In Conclusion CTRP Topics covered today: -Registering trials with and without NCT# Adding participating site infornation -ICD-9 and ICD-10 codes -Trial data verification – every 6 months -Use status change in registry to correct status dates during validation and when viewing TSRs -Accrual reporting on industrial trials -Indicating NCI grant funding during trial registration (some centers not entering the P30 when registering the trial in CTRP) -CTRP Outreach calls to Cancer Centers

26. CTRP 3.10 – User Guides CTRP User Guides https://wiki.nci.nih.gov/display/CTRPdoc/NCI+Clinical+Trials+Reporting+Program +%28CTRP%29+User%27s+Guides CTRP Registration Site User Guide https://wiki.nci.nih.gov/display/CTRPdoc/Contents+-+CTRP+Registration+Site+User%27s+Guide+v3.10 CTRP Subject Accrual User Guide https://wiki.nci.nih.gov/display/CTRPdoc/Contents+-+CTRP+Subject+Accrual+User%27s+Guide+v3.10

27. Send questions / topics for future calls

28. Thank You