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pdfChange Summary of all Information Collection Data Element and Response Changes
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
PreTransplant
Clinical Trial
Essential Data Participants
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
BMT
CTN,COG,Other,PIDTC Change/Clarification of
,RCI BMT,USIDNET
Response Options
yes
no
Study Sponsor
PreTransplant
Essential Data Allogeneic Donors yes
yes
Non-NMDP unrelated
donor ID:
open text
PreTransplant
Autologous
Essential Data Transplant
PreTransplant
Essential Data
yes
yes
Change/Clarification of
Information Requested
G-CSF (filgrastim,
Neupogen), Pegylated
G-CSF (pegfilgrastim,
What agents were
Neulasta), Plerixafor
used to mobilize the (Mozobil), Combined
autologous recipient with chemotherapy,
for this HCT? (check all Anti-CD20 (rituximab, Change/Clarification of
that apply)
Rituxan), Other agent Response Options
Was mechanical
ventilation used for
COVID-19 (SARS-CoVChange/Clarification of
2) infection?
No,Yes
Information Requested
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Study Sponsor
BMT
CTN,COG,Other,PIDTC,RCI
BMT,USIDNET, PedAL
Non-NMDP unrelated donor
ID:Registry donor ID:
open text
G-CSF (TBO-filgrastim,
filgrastim, Granix,
Neupogen) ,GM-CSF
(sargramostim, Leukine),
Pegylated G-CSF
(pegfilgrastim, Neulasta),
Plerixafor (Mozobil),
What agents were used to
Combined with
mobilize the autologous recipient chemotherapy, Anti-CD20
for this HCT? (check all that
(rituximab, Rituxan), Other
apply)
agent
Was mechanical ventilation used
given for COVID-19 (SARS-CoV-2)
infection?
No,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
Capture data accurately
Be consistent with current clinical
landscape, improve transplant outcome
data
Examples added or typographical errors
corrected for clarification
Page 1 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Breast cancer
Central nervous
system (CNS)
malignancy (e.g.,
glioblastoma,
astrocytoma)
Gastrointestinal
malignancy (e.g.,
colon, rectum,
stomach, pancreas,
intestine, esophageal)
Genitourinary
malignancy (e.g.,
kidney, bladder,
ovary, testicle,
genitalia, uterus,
cervix, prostate)
Leukemia
Lung cancer
Lymphoma (includes
Hodgkin & nonHodgkin lymphoma)
MDS / MPN
Melanoma
Multiple myeloma /
plasma cell disorder
Specify prior
malignancy (check all (PCD)
Change/Clarification of
Oropharyngeal cancer Response Options
that apply)
(e.g., tongue, buccal
PreTransplant
Comorbid
Essential Data Conditions
Yes
no
PreTransplant
Comorbid
Essential Data Conditions
Yes
no
Specify other skin
malignancy: (prior)
no
Height at initiation of ___ ___ ___ inches
pre-HCT preparative ___ ___ ___ cms
regimen:
PreTransplant
Essential Data
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
open text
Proposed Information
Collection Data Element (if
applicable)
Specify prior malignancy (check
all that apply)
Deletion of Information
Requested
Specify other skin malignancy:
(prior)
Change/Clarification of
Response Options
Height at initiation of pre-HCT
preparative regimen:
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Breast cancer
Central nervous system
(CNS) malignancy (e.g.,
glioblastoma, astrocytoma)
Gastrointestinal malignancy
(e.g., colon, rectum,
stomach, pancreas,
intestine, esophageal)
Genitourinary malignancy
(e.g., kidney, bladder, ovary,
testicle, genitalia, uterus,
cervix, prostate)
Leukemia Acute myeloid
leukemia
Chronic myeloid leukemia
Acute lymphoblastic
leukemia
Chronic lymphoblastic
leukemia
Lung cancer
Lymphoma (includes
Hodgkin & non-Hodgkin
lymphoma)
MDS / MPN
Melanoma
Multiple myeloma / plasma Be consistent with current clinical
cell disorder (PCD)
landscape, improve transplant outcome
Oropharyngeal cancer (e.g., data
tongue, buccal mucosa)
open text
___ ___ ___ inches
___ ___ ___ cms
Reduce redundancy in data capture
Capture data accurately
Page 2 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Pre-HCT
Preparative
Regimen
Additional
Drugs Given
In the PeriTransplant
Period
Additional
Drugs Given
In the PeriTransplant
Period
Additional
Drugs Given
In the PeriTransplant
Period
Additional
Drugs Given
In the PeriTransplant
Period
Response
required if
Additional Sub
Domain applies
no
no
no
no
no
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
no
Bendamustine,Busulfa
n,Carboplatin,Carmust
ine,Clofarabine,Cyclop
hosphamide,Cytarabin
e,Etoposide,Fludarabi
ne,Gemcitabine,Ibritu
momab
tiuxetan,Ifosfamide,Lo
mustine,Melphalan,M
ethylprednisolone,Oth
er,Pentostatin,Propyle
ne glycol-free
melphalan,Rituximab,
Thiotepa,Tositumoma Change/Clarification of
Drug (drop down list) b,Treosulfan
Response Options
no
no
no
no
ALG, ALS, ATG, ATS
Alemtuzumab
(Campath)
Defibrotide
KGF
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
no,yes
no,yes
No,Yes
No,Yes
Change/Clarification of
Information Requested and
Response Option
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Drug (drop down list)
Bendamustine,Busulfan,Car
boplatin,Carmustine,Clofara
bine,Cyclophosphamide,Cyt
arabine,Etoposide,Fludarabi
ne,Gemcitabine,Ibritumom
ab
tiuxetan,Ifosfamide,Lomusti
ne,Melphalan,Methylpredni
solone,Other,Pentostatin,Pr
opylene glycol-free
melphalan,Rituximab,Thiot
epa,Tositumomab,Treosulfa
n, Azathioprine,
Bortezomib, Cisplatin,
Be consistent with current clinical
Hydroxyurea, and
landscape, improve transplant outcome
Vincristine.
data
ALG, ALS, ATG, ATS,
Alemtuzumab, Defibrotide, KGF,
Ursodiol
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
no,yes (check all that apply) that apply"
Deletion of Information:
Merged to Check all that Apply Alemtuzumab (Campath)
Deletion of Information:
Merged to Check all that Apply Defibrotide
Deletion of Information:
Merged to Check all that Apply KGF
no,yes
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
No,Yes
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
No,Yes
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
Page 3 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Additional
Drugs Given
In the PeriTransplant
Period
no
no
Covid-19 Impact
no
no
Deletion of Information:
Merged to Check all that Apply Ursodiol
Was the HCT impacted for a
Addition of Information
reason related to the COVID-19
Requested
(SARS-CoV-2) pandemic?
Covid-19 Impact
no
no
Covid-19 Impact
no
Covid-19 Impact
Covid-19 Impact
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
No,Yes
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
no,yes
Covid-19 Impact
Addition of Information
Requested
Is the HCT date different than the
originally intended HCT date?
no,yes
Covid-19 Impact
no
Addition of Information
Requested
Original Date of HCT
YYYY/MM/DD
Covid-19 Impact
no
no
Addition of Information
Requested
Date estimated
checked
Covid-19 Impact
no
no
Addition of Information
Requested
Is the donor different than the
originally intended donor?
no,yes
Covid-19 Impact
Ursodiol
No,Yes
Covid-19 Impact
no
no
Addition of Information
Requested
Covid-19 Impact
no
no
Addition of Information
Requested
Specify the originally intended
donor
Is the product type (bone
marrow, PBSC, cord blood unit)
different than the originally
intended product type?
Covid-19 Impact
no
no
Addition of Information
Requested
Specify the originally intended
product type
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
unrelated donor, syngeneic
(monozygotic twin) , HLAidential sibling (may include
non-monozygotic twin) ,
HLA-matched other relative
(does NOT include a haploidentical donor), HLAmismatched relative
Covid-19 Impact
no,yes
bone marrow,Other
product,PBSC, cord blood
unit
Covid-19 Impact
Covid-19 Impact
Page 4 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Covid-19 Impact
no
no
Addition of Information
Requested
Covid-19 Impact
no
no
Addition of Information
Requested
Specify other product type
open text
Was the current product thawed
from a cryopreserved state prior
to infusion?
no,yes
Covid-19 Impact
no
no
Addition of Information
Requested
Did the preparative regimen
change from the original plan?
no, yes
Covid-19 Impact
Covid-19 Impact
no
no
Addition of Information
Requested
Did the GVHD prophylaxis change
from the original plan?
no,yes
Covid-19 Impact
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Covid-19 Impact
Covid-19 Impact
Page 5 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Disease
Classification
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Response
required if
Additional Sub
Domain applies
no
yes
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
no
diseases,Acute
lymphoblastic
leukemia (ALL),Acute
myelogenous
leukemia (AML or
ANLL),Chronic
myelogenous
leukemia
(CML),Hemoglobinopa
thies,Histiocytic
disorders,Hodgkin
lymphoma,Inherited
Bone Marrow Failure
Syndromes(If the
recipient developed
MDS or AML, indicate
MDS or AML as the
primary disease.)–
,Disorders of the
immune
system,Inherited
disorders of
metabolism,Inherited
abnormalities of
What was the primary platelets,Myelodyspla
disease for which the stic syndrome (MDS)
HCT / cellular therapy (If recipient has
Change/Clarification of
was performed?
transformed to AML, Response Options
diseases,Acute
lymphoblastic leukemia
(ALL),Acute myelogenous
myeloid leukemia (AML or
ANLL),Chronic myelogenous
leukemia
(CML),Hemoglobinopathies,
Histiocytic
disorders,Hodgkin
lymphoma,Inherited Bone
Marrow Failure
Syndromes(If the recipient
developed MDS or AML,
indicate MDS or AML as the
primary disease.)–
,Disorders of the immune
system,Inherited disorders
of metabolism,Inherited
abnormalities of
platelets,Myelodysplastic
syndrome (MDS) (If
recipient has transformed
to AML, indicate AML as the
primary
disease.),Myeloproliferative
What was the primary disease for neoplasms (MPN)(If
which the HCT / cellular therapy recipient has transformed
was performed?
to AML, indicate AML as the Capture data accurately
Were cytogenetics
tested (karyotyping or
FISH)? (at diagnosis) no,Unknown,yes
Were tests for
molecular markers
performed? (at
diagnosis)
no,Unknown,yes
Change/Clarification of
Information Requested
Were cytogenetics tested
(karyotyping or FISH)? (at
diagnosis or relapse)
no,Unknown,yes
Reduce redundancy in data capture
Change/Clarification of
Information Requested
Were tests for molecular markers
performed? (at diagnosis or
relapse)
no,Unknown,yes
Reduce redundancy in data capture
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Autoimmune
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Autoimmune
Page 6 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Response
required if
Additional Sub
Domain applies
yes
yes
yes
yes
Information
Collection may
be requested
multiple times
yes
yes
yes
yes
yes
yes
yes
no
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Specify CEBPA mutation
Biallelic (double
mutant),Monoallelic (single
mutant),Unknown
Capture data accurately
Change/Clarification of
Information Requested
Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or relapse and last
evaluation)
no,Unknown,yes
Reduce redundancy in data capture
Change/Clarification of
Information Requested
Were tests for molecular markers
performed? (e.g. PCR, NGS)
(between diagnosis or relapse
and last evaluation)
no,Unknown,yes
Reduce redundancy in data capture
Biallelic
(homozygous),Monoal
lelic
(heterozygous),Unkno Change/Clarification of
wn
Response Options
Specify CEBPA
mutation
Were cytogenetics
tested (karyotyping or
FISH)? (between
diagnosis and last
evaluation)
no,Unknown,yes
Were tests for
molecular markers
performed? (e.g. PCR,
NGS) (between
diagnosis and last
evaluation)
no,Unknown,yes
Biallelic
(homozygous),Monoal
lelic
Specify CEBPA
(heterozygous),Unkno
mutation
wn
Biallelic
(homozygous),Monoal
lelic
Specify CEBPA
(heterozygous),Unkno
mutation
wn
Was the recipient in Not
remission by flow
applicable,No,Unknow
cytometry?
n,Yes
Change/Clarification of
Response Options
Change/Clarification of
Response Options
Deletion of Information
Requested
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Specify CEBPA mutation
Biallelic (double
mutant),Monoallelic (single
mutant),Unknown
Capture data accurately
Specify CEBPA mutation
Biallelic (double
mutant),Monoallelic (single
mutant),Unknown
Capture data accurately
Was the recipient in remission by
flow cytometry?
Specify method(s) that was used
to assess measurable residual
disease status (check all that
apply)
Not
applicable,No,Unknown,Yes Reduce redundancy in data capture
Was measurable residual disease
detected by FISH?
no,yes
FISH, Karyotyping, Flow
Cytometry, PCR, NGS, Not
assessed
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 7 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Myelogenous
Classification Leukemia (AML)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by karyotyping assay?
Which leukemia phenotype was
used for detection (check all the
apply)
What is the lower limit of
detection (for the original
leukemia immunophenotype)
What is the lower limit of
detection (for the aberrant
phenotype)
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by flow cytometry?
no,yes
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by PCR?
no,yes
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by NGS?
no,yes
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Change/Clarification of
Information Requested
Were cytogenetics tested
(karyotyping or FISH)? (at
diagnosis or relapse)
no,Unknown,yes
Reduce redundancy in data capture
Change/Clarification of
Information Requested
Were tests for molecular markers
performed? (at diagnosis or
relapse)
no,Unknown,yes
Reduce redundancy in data capture
Change/Clarification of
Information Requested
Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or at relapse and last
evaluation)
Reduce redundancy in data capture
yes
yes
yes
yes
yes
yes
Were cytogenetics
tested (karyotyping or
FISH)? (at diagnosis) no,Unknown,yes
Were tests for
molecular markers
performed? (at
diagnosis)
no,Unknown,yes
Were cytogenetics
tested (karyotyping or
FISH)? (between
diagnosis and last
evaluation)
no,Unknown,yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
no,yes
original leukemia
immunophenotype,
aberrant phenotype
open text
open text
no,Unknown,yes
Page 8 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
yes
yes
yes
no
Current Information
Collection Data
Element (if
applicable)
Were tests for
molecular markers
performed? (e.g. PCR,
NGS) (between
diagnosis and last
evaluation)
Was the recipient in
remission by flow
cytometry?
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Change/Clarification of
no,Unknown,yes
Information Requested
Not
applicable,No,Unknow Deletion of Information
n,Yes
Requested
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Were tests for molecular markers
performed? (e.g. PCR, NGS)
(between diagnosis or relapse
and last evaluation)
no,Unknown,yes
Was the recipient in remission by
flow cytometry?
Specify method(s) that was used
to assess measurable residual
disease status (check all that
apply)
Not
applicable,No,Unknown,Yes Reduce redundancy in data capture
FISH, Karyotyping, Flow
Cytometry, PCR, NGS, Not
assessed
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by FISH?
no,yes
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by karyotyping assay?
Which leukemia phenotype was
used for detection (check all the
apply)
What is the lower limit of
detection (for the original
leukemia immunophenotype)
What is the lower limit of
detection (for the aberrant
phenotype)
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by flow cytometry?
no,yes
yes
no
Addition of Information
Requested
Was measurable residual disease
detected by PCR?
no,yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Reduce redundancy in data capture
no,yes
original leukemia
immunophenotype,
aberrant phenotype
open text
open text
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 9 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Acute
Disease
Lymphoblastic
Classification Leukemia (ALL)
Disease
Myelodysplastic
Classification Syndrome (MDS)
Response
required if
Additional Sub
Domain applies
yes
yes
Hodgkin and NonDisease
Hodgkin
Classification Lymphoma
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
no
Was measurable residual disease
detected by NGS?
no,yes
Change/Clarification of
Information Requested
Specify the cell lines examined to
determine HI status
HI-E,HI-N,HI-P
Classical Hodgkin
Lymphoma
Lymphocyte depleted (154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular sclerosis (152)
Other Classical Hodgkin
Lymphoma
Hodgkin lymphoma, not
otherwise specified (150)
Nodular lymphocyte
predominant Hodgkin
lymphoma
Non-Hodgkin Lymphoma
B-cell Neoplasms
ALK+ large B-cell lymphoma
(1833)
B-cell lymphoma,
unclassifiable, with features
intermediate between
DLBCL and classical Hodgkin
lymphoma (149)
Burkitt lymphoma (111)
Burkitt-like lymphoma with
11q aberration (1834)
Diffuse, large B-cell
lymphoma- Activated B-cell
type (non-GCB) (1821)
Specify the lymphoma histology Diffuse, large B-cell
no
no
Hodgkin lymphoma,
not otherwise
specified (150)
Lymphocyte depleted
(154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular lymphocyte
predominant Hodgkin
lymphoma (155)
Nodular sclerosis
(152)
Non-Hodgkin
Lymphoma
B-cell Neoplasms
ALK+ large B-cell
lymphoma (1833)
B-cell lymphoma,
unclassifiable, with
features intermediate
between DLBCL and
classical Hodgkin
lymphoma (149)
Burkitt lymphoma
(111)
Specify the lymphoma Burkitt-like lymphoma Change/Clarification of
histology
with 11q aberration Response Options
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Addition of Information
Requested
Specify the cell line
examined to
determine HI status
HI-E,HI-N,HI-P
Hodgkin Lymphoma
Proposed Information
Collection Data Element (if
applicable)
Be consistent with current clinical
landscape, improve transplant outcome
data
Examples added or typographical errors
corrected for clarification
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 10 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Hodgkin and NonDisease
Hodgkin
Classification Lymphoma
yes
no
Is the lymphoma
histology reported at
transplant a
transformation from
CLL?
no,yes
Multiple Myeloma
Disease
/ Plasma Cell
Classification Disorder (PCD)
yes
no
Plasma cells in blood
by flow cytometry
Known,Unknown
no
Plasma cells in blood
by morphologic
assessment
Multiple Myeloma
Disease
/ Plasma Cell
Classification Disorder (PCD)
yes
Inherited Bone
Disease
Marrow Failure
Classification Syndromes
Inherited Bone
Disease
Marrow Failure
Classification Syndromes
yes
yes
Disease
Hemoglobinopathi
Classification es
yes
no
no
no
Specify the inherited
bone marrow failure
syndrome
classification
Did the recipient
receive gene therapy
to treat the inherited
bone marrow failure
syndrome?
Did the recipient
receive gene therapy
to treat the
hemoglobinopathy?
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Change/Clarification of
Response Options
Is the lymphoma histology
reported at transplant a
transformation from CLL?
no,yes (Also complete
Chronic Lymphocytic
Leukemia (CLL) )
Capture additional relevent disease
information
Change/Clarification of
Information Requested
Plasma cells in peripheral blood
by flow cytometry
Known,Unknown
Capture data accurately
Change/Clarification of
Known,Unknown
Information Requested
Dyskeratosis
congenita,Fanconi
anemia,Severe
congenital
neutropenia,DiamondBlackfan
anemia,Shwachman- Change/Clarification of
Diamond
Response Options
Plasma cells in peripheral blood
by morphologic assessment
Capture data accurately
Specify the inherited bone
marrow failure syndrome
classification
Known,Unknown
Dyskeratosis
congenita,Fanconi
anemia,Severe congenital
neutropenia,DiamondBlackfan
anemia,ShwachmanDiamond, Other inherited
bone failure syndromes
No,Yes
Deletion of Information
Requested
Did the recipient receive gene
therapy to treat the inherited
bone marrow failure syndrome?
No,Yes
Reduce redundancy in data capture
No,Yes
Deletion of Information
Requested
Did the recipient receive gene
therapy to treat the
hemoglobinopathy?
No,Yes
Reduce redundancy in data capture
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 11 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Inherited
Disease
Disorders of
Classification Metabolism
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Response
required if
Additional Sub
Domain applies
yes
no
Information
Collection may
be requested
multiple times
no
no
Current Information
Collection Data
Element (if
applicable)
Specify inherited
disorders of
metabolism
classification
Specify the shipping
environment of the
product(s)
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Adrenoleukodystroph
y (ALD) (543),Aspartyl
glucosaminidase
(561),ß-glucuronidase
deficiency (VII)
(537),Fucosidosis
(562),Gaucher disease
(541),Glucose storage
disease (548),Hunter
syndrome (II)
(533),Hurler
syndrome (IH) (531),Icell disease
(546),Krabbe disease
(globoid
leukodystrophy)
(544),Lesch-Nyhan
(HGPRT deficiency)
(522),Mannosidosis
(563),MaroteauxLamy (VI)
(536),Metachromatic
leukodystrophy (MLD)
(542),Mucolipidoses,
not otherwise
specified
(540),Morquio (IV)
(535),Mucopolysaccha
ridosis (V)
Room temperature,
Cooled (refrigerator
temperature, not
frozen), Frozen
(cyropreserved),
Other shipping
enfivronment
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response diffuse
Option(s)
Update
Hereditary
Change/Clarification of
Response Options
Specify inherited disorders of
metabolism classification
leukoencephalopathy with
spheroids,
Adrenoleukodystrophy
(ALD) (543),Aspartyl
glucosaminidase (561),ßglucuronidase deficiency
(VII) (537),Fucosidosis
(562),Gaucher disease
(541),Glucose storage
disease (548),Hunter
syndrome (II) (533),Hurler
syndrome (IH) (531),I-cell
disease (546),Krabbe
disease (globoid
leukodystrophy) (544),LeschNyhan (HGPRT deficiency)
(522),Mannosidosis
(563),Maroteaux-Lamy (VI)
(536),Metachromatic
leukodystrophy (MLD)
(542),Mucolipidoses, not
otherwise specified
(540),Morquio (IV)
(535),Mucopolysaccharidosi
s (V)
(538),Mucopolysaccharidosi Be consistent with current clinical
s, not otherwise specified landscape, improve transplant outcome
(530),Niemann-Pick disease data
Change/Clarification of
Response Options
Room temperature, Cooled
(refrigerated gel pack,
refrigerator temperature,
not frozen), Frozen
Specify the shipping environment (cyropreserved), Other
Examples added or typographical errors
of the product(s)
shipping enfivronment
corrected for clarification
Page 12 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Hematopoieti
c Cellular
Transplant
(HCT)
Infusion
Product
Hematopoieti
c Cellular
Transplant
(HCT) Product Cord Blood
Infusion
Product Infusion
Response
required if
Additional Sub
Domain applies
no
no
no
no
no
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
yes
Flow cytometry
Method of testing TNC based,Other
viability
method,Trypan blue
yes
Method of testing
CD34+ cell viability
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Change/Clarification of
Response Options
Method of testing TNC viability
Flow cytometry based
(7AAD, AOPI, AOEB),Other
method,Trypan blue
Flow cytometry
based,Other
method,Trypan blue
Change/Clarification of
Response Options
Method of testing CD34+ cell
viability
Flow cytometry based
(7AAD, AOPI, AOEB), Other Examples added or typographical errors
method,Trypan blue
corrected for clarification
yes
Method of testing
CD3+ cell viability
Flow cytometry
based,Other
method,Trypan blue
Change/Clarification of
Response Options
Method of testing CD3+ cell
viability
Flow cytometry based
(7AAD, AOPI, AOEB), Other Examples added or typographical errors
method,Trypan blue
corrected for clarification
yes
Method of testing
CD3+CD4+ cell
viability
Flow cytometry
based,Other
method,Trypan blue
Change/Clarification of
Response Options
Flow cytometry based
Method of testing CD3+CD4+ cell (7AAD, AOPI, AOEB), Other Examples added or typographical errors
viability
method,Trypan blue
corrected for clarification
yes
Method of testing
CD3+CD8+ cell
viability
Flow cytometry
based,Other
method,Trypan blue
Change/Clarification of
Response Options
Flow cytometry based
Method of testing CD3+CD8+ cell (7AAD, AOPI, AOEB), Other Examples added or typographical errors
viability
method,Trypan blue
corrected for clarification
yes
Total CFU-GM
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Done,Not done
Indicate which Assessments were Total CFU-GM, Total CFUMerged to Check all that Apply Carried out (Check all that apply) GEMM, Total BFU-E
Examples added or typographical errors
corrected for clarification
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
Page 13 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT) Product Cord Blood
Infusion
Product Infusion
Hematopoieti
c Cellular
Transplant
(HCT) Product Cord Blood
Infusion
Product Infusion
Response
required if
Additional Sub
Domain applies
yes
yes
Information
Collection may
be requested
multiple times
yes
yes
Current Information
Collection Data
Element (if
applicable)
Total CFU-GEMM
Total BFU-E
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Done,Not done
Done,Not done
Proposed Information
Collection Data Element (if
applicable)
Merged to Check all that Apply Total CFU-GEMM
Merged to Check all that Apply Total BFU-E
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Done,Not done
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
Done,Not done
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
Page 14 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT) Product
Infusion
Product Analysis
Response
required if
Additional Sub
Domain applies
yes
Information
Collection may
be requested
multiple times
yes
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)Infections: update:
Bacterial
Specify Organism
Code(s):
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga (all
species), 171
Chlamydia
(pneumoniae), 130
Citrobacter (freundii,
other species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173 Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin resistant
(VRE), 136 Escherichia
(also E. coli), 139
Fusobacterium (all
Change/Clarification of
species), 187
Response Options
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response
Option(s)
Update
Bacterial
Infections:
121
Specify Organism Code(s):
inetobacter (all species),
125 Bordetella pertussis
(whooping cough), 128
Campylobacter (all species),
129 Capnocytophaga (all
species), 171 Chlamydia
(pneumoniae), 130
Citrobacter (freundii, other
species), 131 Clostridium
(all species except difficile),
132 Clostridium difficile,
173 Corynebacterium
jeikeium, 134 Enterobacter
(all species), 135
Enterococcus (all species),
177 Enterococcus,
vancomycin resistant (VRE),
136 Escherichia (also E.
coli), 139 Fusobacterium (all
species), 187 Haemophilus
influenzae, 188
Haemophilus noninfluenzae, 146 Klebsiella
(all species), 147
Lactobacillus (bulgaricus,
acidophilus, other species),
189 Legionella
Examples added or typographical errors
pneumophila, 190
corrected for clarification
Page 15 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT) Product
Infusion
Product Analysis
Response
required if
Additional Sub
Domain applies
yes
Information
Collection may
be requested
multiple times
yes
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)Infections: update:
Bacterial
Specify Organism
Code(s):
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga (all
species), 171
Chlamydia
(pneumoniae), 130
Citrobacter (freundii,
other species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173 Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin resistant
(VRE), 136 Escherichia
(also E. coli), 139
Fusobacterium (all
Change/Clarification of
species), 187
Response Options
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response
Option(s)
Update
Bacterial
Infections:
121
Specify Organism Code(s):
inetobacter (all species),
125 Bordetella pertussis
(whooping cough), 128
Campylobacter (all species),
129 Capnocytophaga (all
species), 171 Chlamydia
(pneumoniae), 130
Citrobacter (freundii, other
species), 131 Clostridium
(all species except difficile),
132 Clostridium difficile,
173 Corynebacterium
jeikeium, 134 Enterobacter
(all species), 135
Enterococcus (all species),
177 Enterococcus,
vancomycin resistant (VRE),
136 Escherichia (also E.
coli), 139 Fusobacterium (all
species), 187 Haemophilus
influenzae, 188
Haemophilus noninfluenzae, 146 Klebsiella
(all species), 147
Lactobacillus (bulgaricus,
acidophilus, other species),
189 Legionella
Examples added or typographical errors
pneumophila, 190
corrected for clarification
Page 16 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT) Product
Infusion
Product Analysis
Response
required if
Additional Sub
Domain applies
yes
Information
Collection may
be requested
multiple times
yes
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)Infections: update:
Bacterial
Specify Organism
Code(s):
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga (all
species), 171
Chlamydia
(pneumoniae), 130
Citrobacter (freundii,
other species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173 Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin resistant
(VRE), 136 Escherichia
(also E. coli), 139
Fusobacterium (all
Change/Clarification of
species), 187
Response Options
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response
Option(s)
Update
Bacterial
Infections:
121
Specify Organism Code(s):
inetobacter (all species),
125 Bordetella pertussis
(whooping cough), 128
Campylobacter (all species),
129 Capnocytophaga (all
species), 171 Chlamydia
(pneumoniae), 130
Citrobacter (freundii, other
species), 131 Clostridium
(all species except difficile),
132 Clostridium difficile,
173 Corynebacterium
jeikeium, 134 Enterobacter
(all species), 135
Enterococcus (all species),
177 Enterococcus,
vancomycin resistant (VRE),
136 Escherichia (also E.
coli), 139 Fusobacterium (all
species), 187 Haemophilus
influenzae, 188
Haemophilus noninfluenzae, 146 Klebsiella
(all species), 147
Lactobacillus (bulgaricus,
acidophilus, other species),
189 Legionella
Examples added or typographical errors
pneumophila, 190
corrected for clarification
Page 17 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Hematopoieti
c Cellular
Transplant
(HCT) Product
Infusion
Product Analysis
Response
required if
Additional Sub
Domain applies
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)Infections: update:
Bacterial
yes
Specify Organism
Code(s):
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga (all
species), 171
Chlamydia
(pneumoniae), 130
Citrobacter (freundii,
other species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173 Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin resistant
(VRE), 136 Escherichia
(also E. coli), 139
Fusobacterium (all
Change/Clarification of
species), 187
Response Options
Specify the recipient's
survival status at the
date of last contact
Alive,Dead
PostTransplant
Essential Data
no
yes
PostTransplant
Subsequent
Essential Data Transplant
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response
Option(s)
Update
Bacterial
Infections:
121
Specify Organism Code(s):
inetobacter (all species),
125 Bordetella pertussis
(whooping cough), 128
Campylobacter (all species),
129 Capnocytophaga (all
species), 171 Chlamydia
(pneumoniae), 130
Citrobacter (freundii, other
species), 131 Clostridium
(all species except difficile),
132 Clostridium difficile,
173 Corynebacterium
jeikeium, 134 Enterobacter
(all species), 135
Enterococcus (all species),
177 Enterococcus,
vancomycin resistant (VRE),
136 Escherichia (also E.
coli), 139 Fusobacterium (all
species), 187 Haemophilus
influenzae, 188
Haemophilus noninfluenzae, 146 Klebsiella
(all species), 147
Lactobacillus (bulgaricus,
acidophilus, other species),
189 Legionella
Examples added or typographical errors
pneumophila, 190
corrected for clarification
Change/Clarification of
Response Options
Specify the recipient's survival
status at the date of last contact
Alive,Dead (Complete
recipient death data)
Capture additional relevent disease
information
Addition of Information
Requested
Was this infusion a donor
lymphocyte infusion (DLI)?
no,yes
Capture additional relevent disease
information
Page 18 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
PostTransplant
Subsequent
Essential Data Transplant
yes
yes
Addition of Information
Requested
PostTransplant
Subsequent
Essential Data Transplant
yes
yes
Addition of Information
Requested
Number of DLIs in this reporting
period
Are any of the products,
associated with this course of
cellular therapy, genetically
modified?
PostTransplant
Graft vs. Host
Essential Data Disease
yes
yes
Date maximum overall
grade of acute GVHD: YYYY/MM/DD
Change/Clarification of
Information Requested
First date maximum overall grade
of acute GVHD:
YYYY/MM/DD
PostTransplant
Graft vs. Host
Essential Data Disease
yes
yes
Date estimated
Deletion of Information:
Merged to Check all that Apply Date estimated
yes
Defibrotide,Nacetylcysteine,Other
therapy,Tissue
Specify therapy (check plasminogen activator Change/Clarification of
all that apply)
(TPA),Ursodiol
Response Options
Specify therapy (check all that
apply)
yes
Did a new malignancy,
myelodysplastic,
myeloproliferative, or
lymphoproliferative
disease / disorder
occur that is different
from the disease /
disorder for which the
HCT or cellular
therapy was
performed?
No,Yes
Did a new malignancy,
myelodysplastic,
myeloproliferative, or
lymphoproliferative disease /
disorder occur that is different
from the disease / disorder for
No,Yes (Also complete
which the HCT or cellular therapy Subsequent Neoplasms) ,
was performed?
previosly reported
PostTransplant
Essential Data
PostTransplant
Essential Data
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
checked
Change/Clarification of
Response Options
__ __
no, yes
checked
Capture additional relevent disease
information
Capture additional relevent disease
information
Capture data accurately
Reduce burden: expanded response
options to include responses previously
reported manually or created a "check all
that apply"
Defibrotide,Nacetylcysteine,Other
therapy,Tissue plasminogen
activator (TPA),Ursodiol,
Be consistent with current clinical
Enoxaparin (Lovenox),
landscape, improve transplant outcome
Heparin
data
Capture additional relevent disease
information
Page 19 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
PostTransplant
Chimerism Study
Essential Data Performed
yes
yes
Date of birth:
YYYY/MM/DD
Change/Clarification of
Information Requested
PostTransplant
Chimerism Study
Essential Data Performed
yes
yes
Sex
female,male
Change/Clarification of
Information Requested
yes
Method
Fluorescent in situ
hybridization (FISH)
for XX/XY,Karyotyping
for
XX/XY,Other,Restrictio
n fragment-length
polymorphisms
(RFLP),VNTR or STR, Change/Clarification of
micro or mini satellite Response Options
yes
Were donor cells
detected?
PostTransplant
Chimerism Study
Essential Data Performed
PostTransplant
Chimerism Study
Essential Data Performed
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
No,Yes
Deletion of Information
Requested
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Donor Date of birth:
YYYY/MM/DD
Capture data accurately
Donor Sex
female,male
Capture data accurately
Method
PCR(includes quantitative,
real time, and fluorescent
multiplex), Fluorescent in
situ hybridization (FISH) for
XX/XY,Karyotyping for
XX/XY,Other,Restriction
fragment-length
polymorphisms
(RFLP),VNTR or STR, micro Examples added or typographical errors
or mini satellite
corrected for clarification
Were donor cells detected?
No,Yes
Reduce redundancy in data capture
Page 20 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Post-HCT
Therapy
no
yes
Alemtuzumab,Azacyti
dine,Blinatumomab,B
ortezomib,Bosutinib,C
arfilzomib,Chemother
apy,Dasatinib,Decitabi
ne,Gemtuzumab,Gilte
ritinib,Ibrutinib,Imatin
ib
mesylate,Ixazomib,Le
nalidomide,Lestaurtini
b,Midostaurin,Nilotini
b,Nivolumab,Other
systemic
therapy,Pembrolizum
ab,Pomalidomide,Qui
Specify systemic
zartinib,Rituximab,Sor
therapy (check all that afenib,Sunitinib,Thalid Change/Clarification of
apply)
omide
Response Options
Post-HCT
Therapy
no
yes
Addition of Information
Requested
Post-HCT
Therapy
no
yes
Addition of Information
Requested
Post-HCT
Therapy
no
yes
Addition of Information
Requested
Post-HCT
Therapy
no
yes
Addition of Information
Requested
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Alemtuzumab,Azacytidine,B
linatumomab,Bortezomib,B
osutinib,Carfilzomib,Chemo
therapy,Dasatinib,Decitabin
e,Gemtuzumab,Gilteritinib,I
brutinib,Imatinib
mesylate,Ixazomib,Lenalido
mide,Lestaurtinib,Midostau
rin,Nilotinib,Nivolumab,Oth
er systemic
therapy,Pembrolizumab,Po
malidomide,Quizartinib,Ritu
ximab,Sorafenib,Sunitinib,T
halidomide, Brentuximab
Be consistent with current clinical
Specify systemic therapy (check vendotin, Daratumumab
landscape, improve transplant outcome
all that apply)
(Darzalex)
data
Did a fecal microbiota transplant
Be consistent with current clinical
(FMT) occur since the date of last
landscape, improve transplant outcome
report?
No, Yes
data
Be consistent with current clinical
landscape, improve transplant outcome
Date of FMT
DD/MM/YY
data
Graft versus host disease
Be consistent with current clinical
(GVHD), Clostridium difficle, landscape, improve transplant outcome
Specify the indication for the FMT Other
data
Be consistent with current clinical
landscape, improve transplant outcome
Specify other indication:
open text
data
Page 21 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Relapse or
Progression
Post-HCT
Current
Disease
Status
Current
Disease
Status
Response
required if
Additional Sub
Domain applies
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Specify systemic therapy (check
all that apply)
Alemtuzumab,Azacytidine,B
linatumomab,Bortezomib,B
osutinib,Carfilzomib,Chemo
therapy,Dasatinib,Decitabin
e,Gemtuzumab,Gilteritinib,I
brutinib,Imatinib
mesylate,Ixazomib,Lenalido
mide,Lestaurtinib,Midostau
rin,Nilotinib,Nivolumab,Oth
er systemic
therapy,Pembrolizumab,Po
malidomide,Quizartinib,Ritu
ximab,Sorafenib,Sunitinib,T Be consistent with current clinical
halidomide, Daratumumb landscape, improve transplant outcome
(Darzalex), Venetoclax
data
no
yes
Alemtuzumab,Azacyti
dine,Blinatumomab,B
ortezomib,Bosutinib,C
arfilzomib,Chemother
apy,Dasatinib,Decitabi
ne,Gemtuzumab,Gilte
ritinib,Ibrutinib,Imatin
ib
mesylate,Ixazomib,Le
nalidomide,Lestaurtini
b,Midostaurin,Nilotini
b,Nivolumab,Other
systemic
therapy,Pembrolizum
ab,Pomalidomide,Qui
Specify systemic
zartinib,Rituximab,Sor
therapy (check all that afenib,Sunitinib,Thalid Change/Clarification of
apply)
omide
Response Options
no
yes
Date of most recent
disease assessment
Known,Unknown
Deletion of Information
Requested
no
yes
Date of most recent
disease assessment:
YYYY/MM/DD
Change/Clarification of
Information Requested
Date of most recent disease
assessment
Date of most recent disease
assessment
Date of assesment of current
disease status
Known,Unknown
Reduce redundancy in data capture
YYYY/MM/DD
Reduce redundancy in data capture
Recipient
Death Data
Recipient Death
yes
no
Addition of Information
Requested
Date of death:
YYYY/MM/DD
Reduce redundancy in data capture
Recipient
Death Data
Recipient Death
yes
no
Addition of Information
Requested
Date estimated
checked
Reduce redundancy in data capture
Recipient
Death Data
Recipient Death
yes
no
Addition of Information
Requested
Was cause of death confirmed by Autopsy
autopsy?
pending,No,Unknown,Yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Reduce redundancy in data capture
Page 22 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Recipient
Death Data
Recipient
Death Data
Recipient Death
Recipient Death
Response
required if
Additional Sub
Domain applies
yes
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Addition of Information
Requested
no
no
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Primary cause of
death
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Accidental
death,Acute
GVHD,Adult
respiratory distress
syndrome (ARDS)
(other than
IPS),Bacterial
infection,Cardiac
failure,Chronic
GVHD,Central nervous
system (CNS)
failure,COVID-19
(SARS-CoV2),Cytokine release
syndrome,Diffuse
alveolar damage
(without
hemorrhage),
Disseminated
intravascular
coagulation
(DIC),Fungal infection,
Gastrointestinal (GI)
failure (not liver),Graft
rejection or failure,
Thrombotic
microangiopathy
(TMA) (Thrombotic
Change/Clarification of
thrombocytopenic
Response Options
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Was documentation submitted to
the CIBMTR?
No,Yes
Accidental death,Acute
GVHD,Adult respiratory
distress syndrome (ARDS)
(other than IPS),Bacterial
infection,Cardiac
failure,Chronic
GVHD,Central nervous
system (CNS) failure,COVID19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse
alveolar damage (without
hemorrhage),Diffuse
alveolar hemorrhage
(DAH),Disseminated
intravascular coagulation
(DIC),Fungal
infection,Gastrointestinal
hemorrhage,Gastrointestin
al (GI) failure (not
liver),Graft rejection or
failure,Hemorrhagic
cystitis,Thrombotic
microangiopathy (TMA)
(Thrombotic
thrombocytopenic purpura
(TTP)/Hemolytic Uremic
Syndrome (HUS)),Idiopathic
pneumonia syndrome
Primary cause of death
(IPS),Intracranial
Reduce redundancy in data capture
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 23 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Recipient
Death Data
Recipient Death
Response
required if
Additional Sub
Domain applies
yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
no
death,Acute
GVHD,Adult
respiratory distress
syndrome (ARDS)
(other than
IPS),Bacterial
infection,Cardiac
failure,Chronic
GVHD,Central nervous
system (CNS)
failure,COVID-19
(SARS-CoV2),Cytokine release
syndrome,Diffuse
alveolar damage
(without
hemorrhage),
Disseminated
intravascular
coagulation
(DIC),Fungal infection,
Gastrointestinal (GI)
failure (not liver),Graft
rejection or failure,
Thrombotic
microangiopathy
Contributing cause of (TMA) (Thrombotic
Change/Clarification of
death
thrombocytopenic
Response Options
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Accidental
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response death,Acute
Option(s)
Update
Accidental
Contributing cause of death
GVHD,Adult respiratory
distress syndrome (ARDS)
(other than IPS),Bacterial
infection,Cardiac
failure,Chronic
GVHD,Central nervous
system (CNS) failure,COVID19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse
alveolar damage (without
hemorrhage),Diffuse
alveolar hemorrhage
(DAH),Disseminated
intravascular coagulation
(DIC),Fungal
infection,Gastrointestinal
hemorrhage,Gastrointestin
al (GI) failure (not
liver),Graft rejection or
failure,Hemorrhagic
cystitis,Thrombotic
microangiopathy (TMA)
(Thrombotic
thrombocytopenic purpura
(TTP)/Hemolytic Uremic
Syndrome (HUS)),Idiopathic Be consistent with current clinical
pneumonia syndrome
landscape, improve transplant outcome
(IPS),Intracranial
data
Page 24 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Hematologic
Malignancy: Acute
myeloid leukemia
(AML / ANLL), Other
leukemia,
Myelodysplastic
syndrome (MDS),
Myeloproliferative
neoplasm (MPN),
Overlapping
myelodysplasia /
myeloproliferative
neoplasm (MDS /
MPN), Hodgkin
lymphoma, NonHodgkin lymphoma,
Clonal cytogenetic
abnormality without
leukemia or MDS,
Uncontrolled
proliferation of donor
cells without
malignant
transformation
Solid Tumors:
yes
Specify the new
malignancy
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Oropharyngeal
cancer (e.g. tongue, Change/Clarification of
Response Options
mouth, throat),
Addition of Information
Requested
Specify the new malignancy
Was post-transplant
lymphoproliferative disorder
(PTLD) diagnosed?
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Hematologic Malignancy:
Acute myeloid leukemia
(AML / ANLL), Acute
lymphoblastic leukemia
(ALL), Other leukemia,
Myelodysplastic syndrome
(MDS), Myeloproliferative
neoplasm (MPN),
Overlapping myelodysplasia
/ myeloproliferative
neoplasm (MDS / MPN),
Hodgkin lymphoma, NonHodgkin lymphoma,
Multiple myeloma / plasma
cell neoplasms, Clonal
cytogenetic abnormality
without leukemia or MDS,
Uncontrolled proliferation
of donor cells without
malignant transformation.
Solid Tumors: Bone
sarcoma (regardless of
site), Soft tissue sarcoma
(regardless of site),
Oropharyngeal cancer
Be consistent with current clinical
(e.g. tongue, mouth,
throat), Gastrointestinal landscape, improve transplant outcome
data
malignancy (e.g.
No,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 25 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
Specify type of PTLD
Be consistent with current clinical
Monomorphic,Polymorphic, landscape, improve transplant outcome
Unknown
data
yes
Addition of Information
Requested
yes
Addition of Information
Requested
Specify oropharyngeal cancer
yes
Addition of Information
Requested
Specify gastrointestinal
malignancy
yes
Addition of Information
Requested
Bladder,Cervix,Kidney,Ovar
y,Prostate,Testicle,Uterus, Be consistent with current clinical
Other genitourary
landscape, improve transplant outcome
Specify genitourinary malignancy malignancy
data
yes
Addition of Information
Requested
Be consistent with current clinical
Glioma,Meningioma,Other landscape, improve transplant outcome
CNS malignancy
data
yes
Addition of Information
Requested
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Specify CNS malignancy
Was PTLD confirmed by biopsy?
Mouth,Throat,Tongue,
Other oropharyngeal cancer
Anus,Colon,Esophagus,Liver
,Pancreas,Rectum,Small
intestine (DUODENUM,
JEJUNUM, ILEUM),Stomach,
Other gastrointestinall
cancer
No,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Be consistent with current clinical
landscape, improve transplant outcome
data
Page 26 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
yes
Addition of Information
Requested
Was documentation submitted to
the CIBMTR? (e.g. pathology
report)
No,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
Was there EBV reactivation in the
blood?
No,Not Done,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
How was EBV reactivation
diagnosed?
yes
Addition of Information
Requested
Specify other method:
Other method,Qualitative
PCR of blood,Quantitative
PCR of blood
Be consistent with current clinical
landscape, improve transplant outcome
data
open text
Be consistent with current clinical
landscape, improve transplant outcome
data
_____ copies/ml
yes
Addition of Information
Requested
Quantitative EBV viral load of
blood: At diagnosis
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
Was a quantitative PCR of blood
performed again after diagnosis? No,Yes
Be consistent with current clinical
landscape, improve transplant outcome
data
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
Page 27 of 28
Information
Information Collection
Collection Domain
Domain Sub- Additional Sub
Type
Domain
Response
required if
Additional Sub
Domain applies
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Subsequent
Neoplasms
New Malignancy,
Lymphoproliferati
ve or
Myeloproliferative
Disease / Disorder yes
Information
Collection may
be requested
multiple times
Current Information
Collection Data
Element (if
applicable)
Current Information
Collection Data
Element Response Information Collection
Option(s)
update:
Proposed Information
Collection Data Element (if
applicable)
Proposed Information
Collection Data Element Rationale for Information Collection
Response Option(s)
Update
______copies/ml
yes
Addition of Information
Requested
Highest EBV viral load of blood:
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
Was there lymphomatous
involvement?
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
Bone marrow,Central
nervous system (brain or
cerebrospinal
Specify sites of PTLD involvement fluid),Liver,Lung,Lymph
(check all that apply)
node(s),Other,Spleen
Be consistent with current clinical
landscape, improve transplant outcome
data
yes
Addition of Information
Requested
Specify other site:
Be consistent with current clinical
landscape, improve transplant outcome
data
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Change Summary
No,Yes
open text
Page 28 of 28
| File Type | application/pdf |
| File Title | SCTOD Information Collection_to HRSA 2022-03-29.xlsx |
| Author | doleysh |
| File Modified | 2022-03-29 |
| File Created | 2022-03-29 |