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
*Write any questions on the notecards on your desk/table.

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
includes detailed instructions on how to answer questions for each form type
#1 resource (and best friend)
Forms Instruction Manual link

6. Resources to Know Data Management Guide link
includes detailed guidance on how/ when forms come due, data quality, CRF/TED level participation, etc.
Data Management Guide link
contains training for data submission into FN3
FormsNet3 Training Guide link
view previous audio & visual Tandem/ TCT presentations
Conference Materials link
view pertinent news/ updates
Newsletters & eBlasts link
*Verbally say Comprehensive Research Form, Transplant Essential Data

7. Resources to Know educational opportunities available at any time
Online Training link
contains forms currently in use
Data Collection Forms link
contains archived forms
an ECF must be completed to update non- editable form versions
Retired Forms link
Non-editable forms include AUD forms.

8. Contact Information
CRC
Find your center’s CRC here
Assist with any questions related to CIBMTR data submission
Cellular Therapy Coordinators
Assist with specific cellular therapy questions
NMDP Service Desk ,
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
Data Management Guide link
How Forms Come Due
View applicable instance info.
Contact your CRC

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
Report on the appropriate follow-up form in FN3
Ensure the correct date of contact is captured
New Pre-TEDs (F2400/ F2402) will be generated in FN3
Follow-up reporting on the prior HCT ends
Follow-up reporting continues for the most recent HCT

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
Report subsequent Auto HCT
Indication captured as graft failure/ insufficient hematopoietic recovery
New Pre- TEDs are not generated
Follow-up Reporting continues for the prior HCT

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
*FIX table so its aligned better

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 Single Product
Number of Products
Single Product
All of the following criteria must be met:
Single donor/cell source
Single mobilization method
Single collection method
One
Multiple Products
One or more of the following criteria must be met:
Multiple donors/cell sources
Multiple mobilization methods
Multiple collection methods
Multiple – one to represent each donor/cell source, mobilization method, and/or collection method
*From Appendix E

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. *There is a change of mobilization after each collection.
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. 1 Product! Product Question #2
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. *The collection on day 4 resulted in a change of mobilization.
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. Great News! Ethnicity and Race
With the new revision of the 2400/2000, Ethnicity and Race will be reported on the F2804 and then auto-populated onto the F2400.

51. Date of Death and Contact Date
What’s wrong?
The date of death and the actual contact date on the appropriate follow-up form should be the same (F2900 and F2100).
If they are not the same, additional follow-up forms continue to come due.

52. Updating the CRID Assignment Form (F2804)
What’s wrong?
When updating the CRID assignment form (F2804), the updated data does not auto-populate on forms that have previously been completed (i.e. F2400)
Date of Birth
Missing RID
Gender

53. Updating the CRID Assignment Form (F2804)
How to update the F2804

54. Updating the CRID Assignment Form (F2804)
What to do after updating the F2804
Reprocess the F2400
Reprocess the F2000 *only retired versions (an ECF may be required)
Reprocess all F2450s *only retired versions (an ECF may be required)
Double check the update has transferred to the reprocessed form

55. When to Contact your CRC

56. You need a CPI forms DUE list. Should you contact your CRC?

57. Generate Forms Due List in FN3
CPI Forms Due List
Contact Your CRC
CRCs can provide the center with the forms due list and summary report upon request
CRCs also provide the center with the forms due list and summary report at designated times throughout the trimester
Generate Forms Due List in FN3
Navigate to “Center Forms Due” under the “Recipient” tab in FN3
Select “CPI Forms”
Filter for the appropriate CPI Period
Export to Excel
Remember to remove any Auto infusions prior to 12/3/2007

58. CPI Forms Due List

59. Clear a Form
A form has accidentally been opened in ‘edit’ mode and is now in SVD status. Should you contact your CRC?
A form has accidentally been completed/ submitted for the incorrect CRID. Should you contact your CRC?

60. Clear a form in SVD status
Contact Your CRC
CRCs can clear a completed form
CRCs can reset a LTF/SUR form
Clear a form in SVD status
Navigate to the form under the “Recipient” tab in FN3
Click the ‘edit form’ icon followed by the ‘clear form’ icon

61. Reporting Recipient Death
Date of death was reported on the appropriate F2450, but the F2900 did not come DUE. Should you contact your CRC?

62. Reporting Recipient Death
When the recipient is on the TED track, the Recipient Death Data F2900 will not come due in FN3.
When the recipient is on the CRF track, the DOD reported on the F2900 must match the DOC reported on the appropriate follow-up F2100.
F2100 DOC
F2900 DOD

63. Links Forms Instruction Manual
Data Management Guide
FormsNet3 Training Guide
Conference Materials
Newsletters & eBlasts
Online Training
Data Collection Forms
Retired Forms