1 / 63

CRC Interactive Presentation

CRC Interactive Presentation. Stephanie Meyers and Amalia Hantke February 21, 2019. *There are no conflicts of interest to disclose. Objectives. Data Management Resources Form Status Subsequent Transplants Comorbidities Overview Duplicate CRID and Transfers Number of Products

winola
Download Presentation

CRC Interactive Presentation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related