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 Journey Matthew Klein, Stephanie Meyers, and Danielle Vitali TRAINING & DEVELOPMENT | 2 . NEW DM ONBOARDING 2020 | 2 . 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 TRAINING & DEVELOPMENT | 3 . NEW DM ONBOARDING 2020 | 3 . 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
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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
TRAINING & DEVELOPMENT | 2 .NEW DM ONBOARDING 2020 | 2 .
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
TRAINING & DEVELOPMENT | 3 .NEW DM ONBOARDING 2020 | 3 .
What is a CRID?
• CIBMTR Research ID = CRID
– Unique, lifelong identifier assigned when an individual is registered
therapy (non-HCT), marrow toxic injury therapy, or non-cellular
therapy.
• This form will come due upon the completion of the F2804.
2804 2814
TRAINING & DEVELOPMENT | 15 .NEW DM ONBOARDING 2020 | 15 .
Indication for CRID Assignment (F2814)
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
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TRAINING & DEVELOPMENT | 16 .NEW DM ONBOARDING 2020 | 16 .
Indication for CRID Assignment (F2814)
• 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).
TRAINING & DEVELOPMENT | 17 .NEW DM ONBOARDING 2020 | 17 .
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.
TRAINING & DEVELOPMENT | 18 .NEW DM ONBOARDING 2020 | 18 .
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
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TRAINING & DEVELOPMENT | 19 .NEW DM ONBOARDING 2020 | 19 .
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.
TRAINING & DEVELOPMENT | 20 .NEW DM ONBOARDING 2020 | 20 .
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
TRAINING & DEVELOPMENT | 21 .NEW DM ONBOARDING 2020 | 21 .
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.
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TRAINING & DEVELOPMENT | 22 .NEW DM ONBOARDING 2020 | 22 .
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
TRAINING & DEVELOPMENT | 23 .NEW DM ONBOARDING 2020 | 23 .
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 …
TRAINING & DEVELOPMENT | 24 .NEW DM ONBOARDING 2020 | 24 .
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’.
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TRAINING & DEVELOPMENT | 25 .NEW DM ONBOARDING 2020 | 25 .
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
TRAINING & DEVELOPMENT | 26 .NEW DM ONBOARDING 2020 | 26 .
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.
TRAINING & DEVELOPMENT | 27 .NEW DM ONBOARDING 2020 | 27 .
Post-TED Follow-Up (F2450)
Captures the following information:
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TRAINING & DEVELOPMENT | 28 .NEW DM ONBOARDING 2020 | 28 .
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
TRAINING & DEVELOPMENT | 29 .NEW DM ONBOARDING 2020 | 29 .
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…
TRAINING & DEVELOPMENT | 30 .NEW DM ONBOARDING 2020 | 30 .
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)
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TRAINING & DEVELOPMENT | 31 .NEW DM ONBOARDING 2020 | 31 .
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.)
TRAINING & DEVELOPMENT | 32 .NEW DM ONBOARDING 2020 | 32 .
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
TRAINING & DEVELOPMENT | 33 .NEW DM ONBOARDING 2020 | 33 .
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