1. CTRP User Call March 5, 2014 Gene Kraus CTRP Program Director

2. Agenda Welcome CTRP Topics -Consortia Trials -Trial Data Verification -Accrual -User Accounts (Create, Delete, Change) Site Administrator -Trial Status Wrap-up

3. Consortia Trials

4. What is a “Consortia Trial” A Consortia Trial is a multi-institutional trial, within scope for CTRP, which does not fall within the current guidelines for Data Submission and Accrual Reporting for trials in the Institutional, Peer-Reviewed and National categories. An example might be a National Heart, Lung and Blood Institute (NHLBI) trial. Consortia trials are registered in CTRP as Industrial/Other

5. Importing an Industrial/Other Trial from ClinicalTrials.gov

7. Accrual reporting for Consortia Trials Similar to industrial trials, Consortia accrual reporting will be Summary Accrual only. -Cancer Centers will report to CTRP all of their individual accrual information for the consortia trial.

8. Registering an Industrial Trial without an NCT Number In the Rare Event that a center should find it necessary to register a trial in CTRP that does not have an NCT number, there will a list / template of the necessary data elements that need to be sent to the CTRO for them to Manually register the trial in CTRP. For now, contact CTRO and they will work with you individually on these.

9. Trial Data Verification

10. 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 CTRP generated XML will have an updated file for ClinicalTrials.gov.

11. Trial Data Verification Trials must now be reviewed for accuracy twice each year. -The Date is calculated by last verification date Automated E-mail reminders will now be 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 Verification ability will be available to trial owners or submitters.

12. Viewing the TSR file for Trial Verification – Newly Identified Problems For a subset of trials, a user may be unable to view the TSR for their trial when trying to do a trial verification. This is being worked on by the CTRP development team and will be corrected in an upcoming release. In the mean time….

13. Viewing the TSR file for Trial Verification: To view the TSR, your trial must meet the following criteria in order for the "Send TSR/XML" action to appears: -You are the trial owner. -The trial is a “complete” trial (i.e., not Industrial/Other) -Processing status is one of the following: ABSTRACTION_VERIFIED_NORESPONSE, ABSTRACTION_VERIFIED_RESPONSE -ClinicalTrials.gov XML Required indicator must be YES -Status dates must be valid, e.g., anticipated primary completion date cannot be in the past If your trial does not meet these criteria, you will be unable to view the TSR.

14. Trial Verification – Cannot View TSR

15. Sample NCI CTRP Registration

16. Continued Sample NCI CTRP Registration

17. Error Message

18. Verification Challenge Scenario: The Available Action tab does not include “View TSR/XML” Cause #1: Error in trial data, generally, status dates (e.g. Anticipated Primary Completion Date is now in the past) Fix: 1.Use the “Update” function to view trial data, particularly status dates. 2.Update status and other registration elements as appropriate. This may enable you to view the TSR. 3.View TSR/XML should appear. 4.If not, contact CTRO.

19. Verification Challenge Scenario: The Available Action tab does not include “View TSR/XML” Cause #2: XML Required = No or Responsible Party field is blank Fix: 1.Use the “Update” function to view trial data, submit the update with responsible party info 2.View TSR/XML should be available. If not: 3.Send email to CTRO: With required information to set XML Required = Yes. The CTRO will update your trial, and you will then be able to view TSR prospectively. With the required information for the update, if you elect XML Required =No.

20. Update Challenge Scenario: Selecting “ Update ” from the trial action menu produces the following error message Unable to update, contact CTRO Cause: XML Required = No or Responsible Party field is blank Workaround: 1.Send email to CTRO with required information to set XML Required = Yes and the data for update 2.Send email to CTRO with required information for the update, keeping XML Required = No. This will allow an update but not see TSR Or 3.Submit the information for the update as an amendment. Info will be updated, but you will not see the TSR

21. Required Fields: XML Required = Yes If you decide to change your registration from XML=No to XML=Yes, please submit the following data elements: Sponsor Responsible Party Trial Oversight Authority Country Trial Oversight Authority Organization Name FDA Regulated Intervention Indicator Section 801 Indicator Delayed Posting Indicator Data Monitoring Committee Appointed Indicator

22. CTRP Accrual Issues

23. Reporting Accrual information Background Subject Accruals CTRP now has the COMPLETE set of ICD-9 codes to allow users to select codes such as Bone Marrow Donor, Healthy Volunteer, etc. CTRP now handles ICD-0-3 codes. CTRP is planning to accept ICD-10 codes in the future. The CTRP system no longer checks a trial's gender eligibility criterion when processing accrual submissions.

24. Who is responsible for submitting accrual data for trials in CTRP? The Lead Organization/Coordinating Center is responsible for submitting accrual data for all patient accruals 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 (cooperative group) trials in CTRP, this is transferred internally.

25. How will I know if my accrual submission was successfully uploaded in the CTRP Accrual Site? An email notification from the NCI CTRO will be sent to the user confirming a successful or unsuccessful accrual submission. Snapshots of successful and unsuccessful accrual submissions on following pages *Contact CTRO ncictro@mail.nih.gov if you have questions about your accrual submission or do not receive email notification for your accrual submission.ncictro@mail.nih.gov

26. NCI CTRP: Accrual SUBMISSION SUCCESSFUL for NCI-2014-00001

27. NCI CTRP: Accrual SUBMISSION ERRORS for NCI 2014-00001

28. What should I do if I receive an error message? The email notification will specify why the submission was unsuccessful. Once the errors have been resolved, please resubmit the file to the CTRP Accrual Site. The most common errors are: ERROR: COLLECTIONS at line 1 User does not have accrual access to study protocol with the identifier NCI-2014-00000 RESOLUTION: User needs to be granted accrual access to trial record. CTRO or Site Administrator can grant accrual access via CTRP Registration Site ERROR: Accrual study site is not valid RESOLUTION: Incorrect CTEP ID or PO-ID used for participating site. Site information can be found in trial record in the CTRP Registration Site

29. Common Error Messages, Continued ERROR: Patient race code is not valid for patient ID 12345 RESOLUTION: Invalid race code used for patient. A list of valid values can be found in the CTRP Subject Accrual User’s Guide v3.10 ERROR: Please use same Disease code system used for trial (SDC, ICD-O-3, ICD9) RESOLUTION: The same Disease code system must be used per trial when loading subject accrual data in the CTRP Accrual Site *Contact CTRO ncictro@mail.nih.gov for questions, concerns, or additional help with file formatting or to address accrual submission error messages.ncictro@mail.nih.gov

30. How do I remove or delete study subject records?

31. How can I submit accrual for a participating site that is not currently listed in the trial record in CTRP If you need to submit subject accrual data for patients at a participating site that is not currently listed in CTRP, please send the following site details to CTRO for processing. Amend your trial registration to include the participating site This should include the required elements (for the new participating site): -Organization name or PO-ID and the associated PI for the site -Site Recruitment Status -Site Recruitment Status Date Optional elements - Program Code - Target Accrual Number - Date Opened for Accrual (mandatory if Closed for Accrual date is provided) - Date Closed for Accrual - Local Trial Identifier (required for abbreviated trials)

32. Some of the trials are grayed out in the Manage Accrual Access tab in the CTRP Registration Site. Why am I unable to assign myself or another user accrual access to these trials? Trials that have been recently submitted to CTRP and have not yet completed the abstraction process cannot be assigned for accrual access. Trials that have a current processing status of On-Hold cannot be assigned for accrual access. -Please contact CTRO to request reason for On-Hold Status Trials that have a trial status of “In Review” cannot be assigned for accrual access. -The status must be updated by the submitter before accrual can be reported.

33. Site Recruitment Status's for Participating Site

34. Other Accrual Questions Does accrual need to be reported for Non-Interventional trials ? -At this time, Accrual is not being required to be reported on these trials, However CTRP is capable of accepting Summary Accrual information on these trials. How can a Center submit accrual for Institutional and Externally Peer-Reviewed trials if we are missing required patient level data elements? -The patient level data elements for Institutional, National and Externally Peer Reviewed were agreed upon in the AACI-NCI Report in 2011, but for those rare exceptions where a data element may be missing in a legacy trial, you will need to contact the CTRP Program Director or the CTRO to try and determine a possible solution. As of September 2012 centers should have amended their consent forms and amended their workflow processes to capture all required elements. Accrual Submissions will fail if all required elements are not included.

35. Add My Site questions After requesting import/registration of an industrial/other trial, please use the “add my site” feature in registry to add your site as a participant. Add my site feature will be available no later than 5 days after registration. -Currently, you cannot add your site until the trial has progress to Accepted CTRP is reviewing the current status flow for these trials, and is considering changes in the next release to make it easier to change site status.

36. User Accounts

37. User Accounts in CTRP In order to get access to CTRP you need to have a CTRP account. This requires that you have an NIH/NCI external account created. Once you have an NCI account, the CBIIT application support team can create a CTRP User account for you. Your CTRP Site Admin will assign you privileges to trials and accrual reporting for trials in your organization. If you know you will be leaving your organization (or changing roles) you should close your CTRP account and possibly your NCI account. Contact CTRO if you have any questions.

38. Site Administration It is important that the CTRP Site Administrator for each center assure that all of the key personnel are associated with the correct organizations within their family. CTRP Director will be reaching out to sites with a list of their staff that do not appear to be associated with the primary organization for their center.

39. Manage Accrual Access from the CTRP Registration Application 1.Assign accrual access by Trial(s) 2.Assign accrual access by Site Grants accrual access to ALL existing & future eligible trials of the affiliated organization in one submission 3.Assign accrual access by Org Family (applies only if the affiliated org is a member of the family) Grants accrual access to ALL existing & future eligible trials of the Org family members in one submission Note: ONLY Site Admins can perform these operations

40. 1.Accrual Access by Trial(s)

41. 2.Accrual Access by Site

42. 3.Accrual Access by Org Family

43. Site vs. Org Family Accrual Submitter This is just to re-iterate the main difference between choosing the Site (second drop-down) vs. the Org Family (3 rd drop-down) option when granting accrual access via CTRP Registration Application - Site option – grants accrual access to the selected user for all existing & future studies for that Site only - Org Family option – grants accrual access to the selected user for all existing & future trials for that Site and all family member organizations of that Site

44. What information is required for reporting subject accrual for trials in CTRP? Abbreviated trials Summary Accrual (cumulative count only) should be reported for Industrial and Industrial/Other trials. Complete trials Patient-level Accrual should be reported for all National, Externally Peer Reviewed and Institutional trials. -Note: Accrual for trials managed by CTEP or DCP PIO, as well as CCR, will be transferred within NCI to CTRP. A complete list of accrual data elements for complete trials can be found in the CTRP Subject Accrual User’s Guide v3.10 https://wiki.nci.nih.gov/display/CTRPdoc/Accrual+Data+Elements+for+Complete+Trials+v3.10

45. Data Elements - Complete Registration (National, Externally Peer-Reviewed, Institutional) trials

46. Trial Status

47. CTRP – Current Trial Status Date CTRP - Current Trial Status Date is the date that the trial entered that status, e.g., -Trial became open to patient accrual (active) on 8/8/13 -The trial remains open and is registered in CTRP on 12/10/13 -Then the date of the current trial status, active, is 8/8/13 Please review / update your trial statuses in CTRP.

48. CTRP 3.10 – User Guides CTRP User Guides https://wiki.nci.nih.gov/display/CTRPdoc/NCI+Clinical+Trials+Reporting+Program+%28CT RP%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

49. In Conclusion CTRP Topics covered today: -Consortia Trials -Trial Data Verification -Accrual -User Accounts (Create, Delete, Change) Site Administrator -Trial Status

50. Send questions / topics for future calls

51. Thank You