form journey - center for international blood and marrow

TRAINING & DEVELOPMENT | 1 .NEW DM ONBOARDING 2020 | 1 .

The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between

the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).

The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between

the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).

Form JourneyMatthew Klein, Stephanie Meyers, and Danielle Vitali


Objectives

• Learn how to create a new CRID

• Become familiar with auto-population and how to update key

fields

• Understand the difference between form tracks (TED vs CRF)

• Practice various reporting scenarios

• Learn how to investigate reporting issues


What is a CRID?

• CIBMTR Research ID = CRID

– Unique, lifelong identifier assigned when an individual is registered

with CIBMTR

– Individual may be receiving:

• Hematopoietic Stem Cell Transplant (HCT)

• Cellular Therapy (CT) (non-HCT)

• Treatment for marrow toxic injuries

• Non-cellular therapy (e.g., chemotherapy, immunotherapy, etc.)

1

2

3


CRID Assignment Form (F2804)

• Collects information required to create the CRID– Certain data fields are used to ensure the same individual does not

inadvertently receive multiple CRID assignments

First Name /

Last Name

DOB /

Location of

Birth

Sex

Ethnicity /

Race /

Race Detail

Social

Security

Number

Mother’s

Maiden

Name

NMDP

Recipient ID

(RID)

IUBMID /

Team ID

Institution-

Specific

Subject ID

Outcomes

Registry


CRID Assignment Form (F2804)

Do not include any identifying information in correspondence

with CIBMTR. Simply providing the CRID will allow us to access

all of the patient demographic information.


Creating a CRID

• Before creating a new CRID, perform a search to ensure a

CRID does not already exist for your recipient at either your

center or another center.

– Follow the steps below to search for a duplicate CRID. Refer to

Document 1: Search CRID Job Aid.

4

5

6


Activity: Duplicate CRID Search Our Recipient

First Name: Mary

Last Name: Poppins

DOB: 1/10/2001

Gender: Female


Activity: Duplicate CRID Search • Login to the FormsNet3 external training environment

(https://formsnet3-extrn.nmdp.org/) using your unique login

information.

• Take 4 minutes to search for the recipient’s first and last name

– Refer to Document 1 for assistance with how to perform this

search.


Activity: Duplicate CRID Search • Were you able to find a duplicate?

– If not, consider broadening your search.

• Try entering the gender and date of birth of the recipient

without the first or last name.

7

8

9

https://formsnet3-extrn.nmdp.org/


Duplicate CRID Search

• Common data entry errors and inconsistencies can prevent

you from finding a duplicate from searching the name alone.

• Using other search criteria can increase your chance of

locating a possible match before a duplicate CRID is created.

You can then narrow your search after an initial broad search

(i.e. DOB and gender).


Duplicate CRID Search

• Since this recipient is from our center, we can verify (despite the

spelling error) this is the same recipient.

• When you encounter a case like this, navigate to the edit icon,

and update the appropriate information (last name spelling,

removing middle name).

Please DO NOT edit this for our search.


Creating a CRID

New recipients, that were not seen to have a duplicate CRID,

need to be registered on the CRID Assignment Form (F2804)

in FN3.

10

11

12


Activity: Creating a CRID (F2804)

• Create a CRID of your own for this form journey and take 5

minutes to complete in the external training environment.

• Refer to Document 2: Sample Recipient EMR in the

recipient materials located in your folder.

• The name, gender and mother's maiden name of your

recipient will be created by you. Feel free to be creative while

creating a recipient name.

• Fields such as SSN and other information are NOT provided

in Document 2 and can be left blank.


Indication for CRID Assignment (F2814)

• The F2814 is used to specify whether the individual will be

receiving Hematopoietic Cellular Transplant (HCT), cellular

therapy (non-HCT), marrow toxic injury therapy, or non-cellular

therapy.

• This form will come due upon the completion of the F2804.

2804 2814



Indication for

CRID

Assignment

includes:

HCT Cellular

Therapy

Marrow Toxic

Injury

Non-Cellular

Therapy

Source:

Auto,

Allo_R,

Allo_U

Planned

HCT Date

Planned

CT DateEvent

Date

Disease/

Study for

Non-CT

13

14

15



• Once a CRID as been registered, the Indication F2814 must be

completed

• Subsequent infusions of the same indication DO NOT require

an additional F2814.

– A subsequent infusion with a new indication may require completion of

another F2814 (See Document 3: Reporting CT Infusions Memo

for an example).


Activity : Complete the Indication Form (F2814)

• Take a 4 minutes to complete for your recipient.

• Again, refer to Document 2: Sample Recipient EMR

Remember: This patient received an HCT, so not all

questions on this form are required to be answered.


From the F2814 to the Pre-TED Forms

HCT

F2400 and F2402

Cell Therapy

F4000

After completing the F2814 you may be asked to complete: - Pre-TED Forms 2400 and 2402 for HCTs

- CT Pre-Infusion Form 4000 for CTs

For our journey examples, we will be reporting HCTs.

2804

2814

2400 /

2402

16

17

18


Pre-TED (F2400)

• The Pre-TED is required for every Allogeneic HCT, as well as

for every Autologous HCT performed at CIBMTR centers who

choose to report on AUTOS.

• The Pre-TED may be submitted to CIBMTR up to two weeks

prior to the start of the recipient’s preparative regimen,

however it may be best to complete this after the transplant

has occurred in case it is cancelled or delayed.


Pre-TED (F2400)

The Pre-TED captures a variety of important Pre-HCT information,

including:

Recipient

Demographic

Data Consent

HCT

Information Donor

Information

Clinical

Status of

Recipient

Comorbid

Conditions

Preparative

Regimen

Peri-

Transplant

Period

Treatment

GVHD

Prophylaxis

Post-HCT

Disease

Therapy

Planned as

of Day 0


Activity : Completing the Pre-TED (F2400)• Refer to Document 2: Sample Recipient EMR

and Document 4: HCT-CI(comorbidity index) Chart

• Use these documents to complete the f2400

• Take 10 minutes to complete.

• REMINDERS FOR THIS TRAINING:

– Any questions you do not have documentation on, report ‘unknown’.

– Certain fields such as date of birth, gender, ethnicity, race, race

detail and NMDP RID will auto populate from the F2804.

– NOTE: This is a mock F2400 for training purposes only and is NOT

representation of real-world reporting practices.

19

20

21


Pre- TED Disease Classification (F2402)

• The second part of the Pre-TED forms is the Disease

Classification Form.

– This form captures important details regarding the recipient’s primary

disease for HCT.

• It is required for all transplants, including subsequent

transplants for the same disease.

2804 2814

2400

2402


Pre-TED Disease Classification (2402)

Report the primary disease for

HCT and the date of diagnosis

in questions 1-2.

ALL(96-163)

ALAL

(164-167)

AML(3-95)

CML(168-178)

MDS(179-258)

MPN(259-371)

Other

Leukemia(372-378)

HL/NHL(379-396)

PCD

(397-443)

You will then be directed to the proper disease section of the F2402.

AND MORE …


Activity: Completion of the F2402

• Refer to Document 5: Training Lymphoma 2402 Status in

your binder pertaining to your training recipient and use these

materials to complete the F2402 .

• Take 6 minutes to complete.

• REMINDERS FOR THIS TRAINING:

– Any questions you do not have documentation on, report ‘unknown’.

22

23

24


Follow-Up Form Track: TED vs CRF

• After completing the Pre-TED forms, you will be

assigned to either the TED (Transplant Essential Data)

or the CRF (Comprehensive Report Forms) track based

on CIBMTR’s selection algorithm.

– NOTE: the algorithm will run every time these forms are

reprocessed.

• Regardless of the track you are on, data will be

collected at the 100d, 6m, 1y, 2y, 3y, 4y, 5y, 6y, and

then every 2 years.

F2400

F2402

F2450

F2400, F2402,

F2000, F2100,

F20xx (inserts),

F21xx( inserts),

F2900

TED

CRF

2804 2814

2400

2402

TED

CRF


Follow-Up Form Track: TED vs CRF

Notice the difference between the tracks?

With the TED track, there is only one form per reporting period, and with

the CRF there are 5 in the 100D period in this case.


Post-TED Follow-Up (F2450)

Captures the following information:

25

26

27


Post-HCT CRF Follow-Up Form (F2100)

Captures the following additional information:

Immune

reconstitution

Immune

Reconstitution

Current

Hematologic

Findings

Engraftment

Syndrome

Infection

ProphylaxisInfection

Organ

Function


CRF Disease Inserts

Along with F2000 and F2100, CRIDs on the CRF track will

usually have disease-specific inserts for each reporting period.

2804 28142400

2402

F2000

F2100

F20xx (inserts)

F21xx( inserts)

2010 / 2110 : AML

2011 / 2111 : ALL

2012 / 2112 : CML

2013 / 2113 : CLL

2014 / 2114 : MDS

2015 / 2115 : JMML

2016 / 2116 : PCD

2018 / 2118 : HL / NHL

2019 / 2119 : WM

2024 / 2124 : SAR

2028 / 2128 : APL

2031 / 2131 : ID

2033 / 2133 : WAS

2034 / 2134 : XLP

2039 / 2139 : HLH

2057 / 2157 : MPN

AND MORE…


CRF Disease Inserts

Disease

Assessment

at Diagnosis

Lab

Assessment

at Diagnosis

Pre-HCT

Therapy

Lab Studies

Last Eval

prior to Prep

Disease

Status Last

Eval prior to

Prep

Disease

Specificity

2016

2116

Disease

Assessment

at Time of

Best

Response

Post-HT

Therapy

Disease

Status at

Time of Eval

2016 vs 2116 (PCD Example)

28

29

30


Activity: What Track Is Your CRID On? • Now that we have completed our F2804, F2814, F2400 and

F2402, your recipient has been assigned to a reporting track

(TED or CRF).

• Can you tell which track your recipient is assigned?

– TED track CRIDs should only have F2450s follow-up forms.

– CRF track CRIDs should have the F2000, F2018 (HL / NHL), F2100,

and F2118 (HL / NHL).

• How many people are on the CRF track?

– On average, about 25% of CRIDs created will go to the CRF track. (Some centers may have more or less than this for a number of reasons including study

participation, consent rates, CRF center status etc.)


Forms 2004 / 2005 / 2006

• Forms 2004 (Infectious Disease Markers), 2005 (HLA-typing)

and 2006 (Infusion) may be generated based on the answers

reported on the Pre-TED F2400.

– These forms may come due for both CRF and TED level reporting

tracks.

• Reporting guidelines can be found in the How Forms Come Due

tables of the Data Management Guide.

2804 2814

2400

2402

2004

2005

2006


Activity: F2004 / 2005 / 2006

• Refer to Document 6: How Forms Come Due (Scenario

One)

– Utilize the How Forms Come Due tables in the Data Management

Guide and Document 7: How Forms Come Due Job Aid to assist

with this scenario.

• Take 5 minutes to review the scenario and determine if the

F2004, F2005 or F2006 should come due given the

information provided.

• Remember the key mentioned earlier.

31

32

33

https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/forms-2004-2005-and-2006

https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/forms-2004-2005-and-2006


F2804 and Auto-Population

• The F2804 is not present in the Forms Grid on the main

recipient page.


F2804 and Auto-Population Continued

• To access the F2804 in FN3, refer to the Search / Edit CRID

Job Aid (Document 1).

• Several categories such as ethnicity, race, date of birth and

NMDP RID are auto-populated on the F2400 from the F2804.

– The only way to update the auto-populated questions on the F2400

is to update the F2804 and then reprocess (re-submit) the F2400.

You do this by clicking the arrow on the form as seen below.


Activity: Updating Auto-Populated Fields

• We have discovered that the DOB reported on your training

recipient should be 04-28-1976.

• Refer to Document 1: Search / Edit CRID Job Aid for steps

on how to edit a previously created CRID.

• Take 4 minutes to update the date of birth on the F2804 and

reprocess the F2400.

34

35

36


Consent

When a recipient receives a transplant at a CIBMTR center, we

expect the recipient to be approached for the Research database

consent. Please see Document 8: Database consent for an

example.


Consent Considerations• If the recipient DOES NOT consent to submit data for research:

– AUTO Transplants will only require Pre-TED forms to be completed.

– ALLO Transplants will be assigned to the TED track and required to

complete only the Pre-TED and Post-TED forms (with the exception of

study participants).

– See Document 9: New Pre-TED Requirement Memo and

Document 10: Completion of pre-TED for all patientsALLO

AUTO


Consent Considerations (AUTO No-Consent)For a subsequent transplant, usually you report the subsequent transplant on a

Post-HCT follow-up form (F2450 or F2100).

• In the case where there was NO consent given for the first AUTO transplant, F2450 and F2100

do not come DUE, so there are no forms to report the subsequent transplant on.

– In this case, contact the CIBMTR Center Support to request new Pre-TEDS be added for the

subsequent transplant. Be sure to include: HCT date, HCT type (Allo_U, Allo_R, Auto), and product

type (BM, PBSC, CBU).

“This recipient had a second auto transplant, but has not signed a CIBMTR consent. Is it

possible to add the F2400 & F2402, so the infusion can be reported?”

37

38

39


Activity: Follow-Up Forms

• Take 4 minutes to review CRID 3913417 in the external

training environment in “Read Only” mode.

• What forms are currently due for this recipient and why?


Follow-Up Form Track Change

• Sometimes a recipient’s CRID will change tracks (from TED

to CRF or vice versa).

- This can happen for any number of reasons including:

• Reprocessing the F2400 to make an update to the form or resolving a

query (makes the algorithm run again).

• CIBMTR updates the track due to enrollment in a study.

• CRID has a subsequent transplant assigned to a new track.


Follow-Up Form Track Change

• Contact the CIBMTR Center Support if you feel a CRID’s

track has changed in error.

“Good afternoon! I was fixing an error on the F2400. When submitting the corrections, a

bunch of new forms populated. We already completed the F2450 100 day and now new

F2100/2118 forms populated. Was this a glitch in the system? If possible, please return the

CRID to the TED track. Thank you!”

40

41

42


Survival Status: Patient Death (TED Track)

Report recipient’s death on F2450 by using the date of death to answer ‘date of

actual contact’. All remaining F2450 forms for subsequent reporting periods will

be automatically removed.

– Death on F2450 can be reported and NO F2900 will come due.

**All forms should be in complete status and

no remaining forms ‘DUE’ after reporting

recipient death.**

2020 01 27F2450


Survival Status: Patient Death (CRF Track) Recipient’s death needs to be reported on BOTH the F2100 and the F2900.

• Report recipient’s death on F2100 by using the date of death to answer ‘date of

actual contact’.

– This will create a F2900 once the F2100 is in CMP status.

• Report recipient’s death on the F2900.

• Once date of death is reported and matches on both completed forms,

subsequent due follow-up forms will be automatically removed

2020 01 27

2020 01 27

F2100

F2900


Activity: Death Reported

• Review the 100D form(s) for CRID 3913003 in ‘Read Only’

mode.

• Take 4 minutes to determine WHY forms are continuing to

come DUE even though death has been reported on the 100d

f2100 and the death form f2900 . (Note : some forms may be

on different pages in FN3)

• Can anyone think of why this is?

• What steps could we take to solve this issue?

43

44

45


Lost to Follow-Up (LTF) and Survival (SUR)

The Lost to Follow-up

Declaration should be

submitted when the transplant

center is unable to establish

ANY contact with the recipient.

• The transplant center should

continue attempt to establish

contact in the subsequent

reporting periods after making the

previous reporting period LTF.



The Survival Status is to be used when you know the recipient is

alive, however ALL efforts to obtain follow-up data on the recipient

have failed.

• In this case, report the recipient’s known survival date.



• To change form status to lost to follow-up or survival, select

the Lost to Follow-up icon below

• The icon only displays for eligible forms and only if the form is

in DUE status

46

47

48



• LTF status means there is NO contact with the recipient

during the entire reporting period.

• SUR status means there HAS BEEN contact to establish

survival, but does not yield any follow-up data (Example:

phone calls, influenza vaccine, etc).

• If you need a form changed from LTF or SUR back to ‘DUE'

after obtaining new information, contact the Center Support

team (CSC).

NOTE: Neither option is available on the 100D forms. As long as the

recipient received an infusion, there is data to report during the

reporting period.


Activity: Lost to Follow-Up (LTF) & Survival (SUR)

• Return to the forms grid for your training recipient and make

the 6M form LTF and the 1Y form SUR.

• Take 4 minutes to practice changing the status of these

forms.

• Please click on the following icon to report these statuses

• After completing this task, what happens if you found

new information?

• How would you update the form status back to 'due' from

LTF or SUR ?


Form Change History

• If you would like to check the history of a form and how

certain questions on each form were answered, use the form

change history tool.

– The icon for this tool will appear as a clock with a green arrow on it.

• See the example below. For each date, an update was made

to this form. Click on the arrows to see WHAT and WHEN

specific changes were made.

49

50

51


Transfers

• One of the most complicated scenarios we come across is

transferring a CRID from once center to another.

• Let's review several transfer scenarios we may encounter.


Transfer Form (F2801)

• When a CRID needs to be transferred from one center to

another, complete the F2801. A center can request the

contact information of the other center’s data manager to work

together to complete the form.

• Once completed, either data manager may submit the form to

the CIBMTR Center Support for processing.


Transfer Form (F2801)

• Refer to Document 11: Transfer Form (F2801) Guide and

Document 12: Transfer form for tips on completing the

form.

• If this is a duplicate CRID, request the CRIDs to be merged

FIRST, and keep the original (oldest) CRID.

– The original CRID should be the CRID entered on F2801.

• The original center will still be able to view the forms they

completed, and the receiving center can view the forms the

original center completed but cannot edit them.

52

53

54


Transfers: Earliest Complete Date

• The date the completed F2801 is received by CIBMTR is

considered the effective date of the transfer.

– Any forms with an earliest complete date prior to the effective date

will remain DUE at the transferring FROM center.

– Any forms with an earliest complete date after the effective date will

become DUE at the transferring TO center.


Transfer Form (2801)

• If a subsequent HCT has occurred, this will need to be

reported on the appropriate follow-up form in order to

generate the new event forms.

– Discuss which center will be reporting the subsequent HCT prior to

submitting the F2801.

• If the recipient transferred their care to a new center but has

not received a subsequent HCT there, the recipient must

consent at the transferring TO center before the F2801 is

submitted.


Transfers : CAR-T Scenarios

• Center A performs HCT and Center B performs CAR-T

– If Center B is reporting the CAR-T infusion to CIBMTR, a transfer is

required to move the reporting responsibility (both HCT and CT) to

Center B.

– If Center B is not reporting CAR-T infusions to CIBMTR, Center A

should still report the CAR-T infusion on the appropriate HCT follow-

up form, and request through CIBMTR Center Support that the

CTED F4000 be made NRQ. A transfer is not required.

• Center A performs CAR-T and Center B performs HCT

– Center B should request a transfer and will be responsible for the

CAR-T follow up forms.

55

56

57


Universal / Combined Follow-up

• Implemented a new “Hard Stop” solution that allows both HCT

and CT forms to be collected for a subsequent infusions

without duplicate reporting.

• Released July 24th, 2020

• All diagrams can be found here: https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/subsequent-infusions-

updates-to-follow-up-reporting


QUESTIONS?

58

59

https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/subsequent-infusions-updates-to-follow-up-reporting

form journey - center for international blood and marrow

Documents