CRC Interactive Presentation

1. CRC Interactive Presentation Stephanie Meyers and Amalia Hantke February 21, 2019 *There are no conflicts of interest to disclose.

2. Objectives • Data Management Resources • Form Status • Subsequent Transplants • Comorbidities Overview • Duplicate CRID and Transfers • Number of Products • Common data clean-ups • When to contact your CRC

3. Data Management Resources

4. Resources to Know • Forms Instruction Manual • Data Management Guide • FormsNet3 Training Guide • Conference Materials • Newsletters & eBlasts • Online Training • Data Collection Forms • Retired Forms

5. Resources to Know https://www.google.com/search?q=joey+and+chandler+in+canoe&biw=1065&bih=834&tbm=isch&source=iu&ictx=1&fir=DSzbTy5FTfK01M%253A%252Cr7ROm1RCLKCYzM%252C_&usg=AI4_-kQEkFp03peiZgvYSlsHi-kgxLx9KQ&sa=X&ved=2ahUKEwjL0NTFkpbgAhUi7YMKHVTVDxwQ9QEwBHoECAAQDA#imgrc=CifTHMHRR2dejM:

6. Resources to Know

7. Resources to Know

8. Contact Information • CRC • Find your center’s CRC here • Assist with any questions related to CIBMTR data submission • Cellular Therapy Coordinators • CIBMTR-CellTherapy@mcw.edu • Assist with specific cellular therapy questions • NMDP Service Desk • 763-406-3411, servicedesk@nmdp.org • Help resolve complex issues regarding FN3/ Traxis access

9. How Forms Come Due Question #1 • The Pre-TED forms were recently completed in FN3. Additional 2450 forms came due, but a Product F2006 was not generated. This product was from a Non-NMDP unrelated donor. Does the F2006 need to be completed? • Note: The Pre-TED indicates the donor was not used for any prior HCTs. In addition, the recipient was ‘not approached’ to sign an IRB-approved consent form to donate research blood samples.

10. How Forms Come Due Question #1

11. How Forms Come Due Question #1

12. Form Status

13. Form Status Codes

14. Resolving Queries

15. Resolving Queries

16. Resolving Queries

17. Resolving Queries Question #1 • When you have searched for forms in QRY status, view the query you want to resolve by… • Clicking on the view error/query report, if available • Going to the form change history • Using either the edit form icon or the view error/query report icon, if available • Clicking on the edit form icon as you normally would to update form data

18. Resolving Queries Question #1 • When you have searched for forms in QRY status, view the query you want to resolve by… • Clicking on the view error/query report, if available • Going to the form change history • Using either the edit form icon or the view error/query report icon, if available • Clicking on the edit form icon as you normally would to update form data

19. Resolving Queries Question #2 • What kind of forms can queries be placed on? • Forms represented with a PDF • Forms represented with an Edit icon • All forms

20. Resolving Queries Question #2 • What kind of forms can queries be placed on? • Forms represented with a PDF • Forms represented with an Edit icon • All forms • If a PDF form is in QRY status, please notify your CRC to resolve the issue. An ECF will be needed.

21. Subsequent Transplants

22. Process • Follow the steps below to report a subsequent transplant in FN3 • Do not create a new Indication F2814

23. Autologous Rescue • Autologous cells infused for graft failure/ insufficient hematopoietic recovery • Purely to reduce the reporting burden, new Pre-TEDs will not come due in FN3

24. Subsequent Transplant Question #1 • The recipient received a subsequent transplant. However the recipient did not sign consent to the research database for the prior auto transplant. No follow-up forms are due in FN3. How do you report this subsequent transplant? • Create a new Indication F2814 • Contact your CRC

25. Subsequent Transplant Question #1 • The recipient received a subsequent transplant. However the recipient did not sign consent to the research database for the prior auto transplant. No follow-up forms are due in FN3. How do you report this subsequent transplant? • Create a new Indication F2814 • Contact your CRC

26. Comorbidities Overview

27. Comorbidities Overview • Clinically significant co-existing disease/ organ impairment at the time of patient assessment prior to prep that may have an effect on HCT outcome • Sorror Paper • Forms Instruction Manual: F2400 & Appendix J

28. Comorbidities Question #1 • Should a hepatic comorbidity be captured on the Pre-TED F2400? • Preparative regimen on 8/19/2018 • HCT on 8/24/2018

29. Comorbidities Question #1 • Do not report a hepatic comorbidity in this case • Although there are two high ALT values between Day -24 and the start of prep, the values are trending downward. • The two values nearest to the start of the prep are normal.

30. Comorbidities Question #2 • Should an infection comorbidity be captured on the Pre-TED F2400? • Known rhinovirus/ enterovirus at the time of transplant • Recipient receives only IVIG treatment prior to HCT

31. Comorbidities Question #2 • Do not report an infection comorbidity in this case • The recipient does not begin treatment prior to the prep and continue beyond Day 0 of HCT

32. Duplicate CRID and Transfers

33. When creating a CRID and this warning appears, • If the potential match is at your center, you can do a CRID search. • If the potential match is at a different center, please take a screenshot of this warning and send it to your CRC, who will inform you if the CRIDs are duplicates.

34. Potential Match at your Center • To search within your own center for potential matches, go to the • Recipient Tab • Assign CRID • Search/Edit CRID

35. Ways to Avoid Duplicate CRIDs • Double check the recipient Medical History. • Use the Search/Edit CRID tool The best way to search for a match is by ‘Gender’ and ‘Date of Birth’. • This is in case of spelling errors in the name, extra information (i.e. middle name/initial), and/or a name change.

36. Potential Match with a Different Center • Request contact information for the other center to confirm the CRIDs are for the same recipient • Initiate a transfer, using the transfer form and send to the other center • Send the completed form to your CRC to complete the process

37. Transfer Form (F2801) • Reminders: • Event date should be the most recent event at the ‘transferring from’ center. • Always double check the DOB! • Make sure all parts are legible for accurate data entry. • The IUBMID and Team ID are either both answered OR are both ‘Not Applicable’. • Once you see the F2801 is DUE in FormsNet3, please do not complete it. Our data entry team will complete this form.

38. Cellular Therapy Transfers • HCT occurs at Center A, and CT occurs at Center B for the same recipient. Both centers will continue to do follow-ups for their respective infusions. • New ability to have two centers report on the same CRID • NO TRANSFER NEEDED • Inform your CRC, who will collaborate with the Cell Therapy team • Center A will report the HCT follow-ups • Center B will report the CT follow-ups

39. Number of Products

40. Definition of Product

41. Product Question #1 • An auto donor receives Filgrastim and undergoes a 2-day collection. The yield is less than desired. • Filgrastim is switched to Mozobil and donor undergoes another 2-day collection. The yield is still less than desired. • After a 4 week rest, the donor receives both Filgrastim and Mozobil and undergoes a 2-day collection. • Cells from all days of collection are infused. • How many products?

42. Product Question #1 3 Products! 1st product: Filgrastim 2nd product: Mozobil 3rd product: Filgrastim + Mozobil *There is a change of mobilization after each collection.

43. Product Question #2 • Day 1-3: Mobilized with GCSF • Day 4: Mobilized with GCSF and Plerixafor • Day 5: Collection day, GCSF and Plerixafor are continued • Day 6: Collection day, GCSF and Plerixafor are continued • Day 7: Collection day • How many products?

44. Product Question #2 1 Product! The medications stayed the same prior to the collection start and throughout the collection process.

45. Product Question #3 • Day 1-3: Mobilized with GCSF • Day 4: Collection, but poor cell count. Re-mobilized with GCSF and Plerixafor • Day 5: Collection day, GCSF and Plerixafor are continued • Day 6: Collection day, GCSF and Plerixafor are continued • Day 7: Collection day • How many products?

46. Product Question #3 2 Products! 1st Product: GCSF (days 1-3) 2nd Product: GCSF and Plerixafor (days 4-6) *The collection on day 4 resulted in a change of mobilization.

47. Common Data Cleanups

48. Common Discrepancies • Death date/contact date discrepancies • Ethnicity and race • Updating the CRID assignment form

49. Ethnicity and Race • What’s wrong? • Ethnicity should be consistent across all F2400s and past F2000 revisions • Race should be consistent across all F2400s and F2000s • Race details should be a subtype of the Race, according to Appendix I

50. Ethnicity and Race Great News! With the new revision of the 2400/2000, Ethnicity and Race will be reported on the F2804 and then auto-populated onto the F2400.