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Cellular Therapy
Data Collection and Quality » Cellular Therapy
When the indication is reported as Cellular therapy (non-HCT) for the patient’s first event, or a post-HCT cellular therapy is reported on an HCT follow-up form, the Cellular Therapy Pre-CTED Form 4000 will come due. Once completed and the data is processed,…
Post-HCT Cellular Therapy (Not Genetically Modified)
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Post-HCT Cellular Therapy (Not Genetically Modified)
This Visio flowchart shows how forms come due when the infusion is Post-Transplant Cellular Therapy (does not include DLIs).
Cell Therapy, Stand-Alone (No HCT Forms)
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Cell Therapy, Stand-Alone (No HCT Forms)
Please review CIBMTR Guidance Document for Reporting Autologous Cellular Therapies to determine if the cellular therapy should be reported to CIBMTR. This Visio flowchart shows how forms come due when the indication is Cellular Therapy (no HCT forms due). …
Q3: Hematopoietic Cellular Transplant (HCT)
FormsNet3 Process and Tool Instructions » 2814: Indication for CRID Assignment » Q3: Hematopoietic Cellular Transplant (HCT)
Questions 3: Is the product genetically modified? For multiple products, report “Yes” if ANY of the products are genetically modified. Genetically modified products include any product where the cells are manipulated via either: Gene transfer: A process…
Q4-6: Non-Cellular Therapy
FormsNet3 Process and Tool Instructions » 2814: Indication for CRID Assignment » Q4-6: Non-Cellular Therapy
Question 4: Specify the disease / study for which non-cellular therapy was given Indicate if the individual is participating in the BMT CTN 17-02 study or receiving non-cellular therapy as treatment for MDS, multiple myeloma, myelofibrosis, sickle cell disease, or…
HCT
Data Collection and Quality » How Forms Come Due » HCT
When the indication is reported as HCT for the patient’s first event, or an HCT is reported on an HCT or cellular therapy follow-up form, the Pre-TED Forms 2400 and 2402 will be the first to come due. Once the Pre-TED forms are complete and the data are processed,…
HCT --> CT
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified)) » HCT --> CT
This Visio flowchart shows how forms come due when the HCT is first and there is combined follow up for the subsequent cellular therapy. Questions disabled on HCT and CT forms Question F4100 F2450 (when TED level HCT F2100 (when CRF level HCT…
CT --> HCT
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified)) » CT --> HCT
This Visio flowchart shows how forms come due when the cellular therapy is first and there is combined follow up for the subsequent HCT. Question F4100 F2450 (when TED level HCT F2100 (when CRF level HCT) Subsequent HCT/CT …
Discrepancy: HCT Date Missing
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: HCT Date Missing
FormsNet3 does not have a record of the HCT reported on the CTA list. For these cases, a CRID exists, and the infusion will need to be reported in FormsNet3. Steps to Follow to Correct Discrepancy For a patient’s first infusion, complete the…
Discrepancy: HCT Date Mismatch
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: HCT Date Mismatch
The HCT event date is discrepant between FormsNet3 and the CTA list. Steps to Follow to Correct Discrepancy If the CTA list is incorrect, centers should correct the CTA list and resubmit via a CIBMTR Center Support ticket. After navigating to the CIBMTR Center…
Co-Infusion (with HCT)
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Co-Infusion (with HCT)
Please see Appendix D: How to Distinguish Infusion Types for a definition of co-infusion. This Visio flowchart shows how forms come due when there is a co-infusion.
Discrepancy: HCT Type Mismatch
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: HCT Type Mismatch
The HCT type is discrepant between FormsNet3 and the CTA list. Steps to Follow to Correct Discrepancy If the CTA list is incorrect, centers should correct the CTA list and resubmit via a CIBMTR Center Support ticket. After navigating to the CIBMTR Center…
Cell Therapy Reporting Levels
Data Collection and Quality » Cellular Therapy » Cell Therapy Reporting Levels
Beginning July 2023, new TED and CRF reporting levels for cellular therapy were created to reduce the burden of data collection. TED and CRF reporting levels are determined by the center reporting preference and infusion details. ! Cell therapy reporting levels are…
Cell Therapy Reporting Preferences
Data Collection and Quality » Cellular Therapy » Cell Therapy Reporting Preferences
Cell therapy reporting preferences took effect in July 2022 and are used to determine how forms come due. *Donor Lymphocyte Infusions (DLIs) are not included as a type of cellular therapy for the purpose of reporting preference. As of September 2022, DLIs are no…
Cell Therapy Training Resources
Data Collection and Quality » Cellular Therapy » Cell Therapy Training Resources
CIBMTR Portal Click HERE to access the Portal (https://portal.cibmtr.org/) Click on the “Training & eLearnings” tile Resources Available on the CIBMTR Portal Self-Guided New Data Manager Onboarding: The Center for International Blood & Marrow…
Cell Therapy Corporate Studies
Corporate Studies and Registries » Cell Therapy Corporate Studies
*Questions regarding any of the below studies should be submitted via CIBMTR Center Support Current CIBMTR Cell Therapy Studies Enrollment into these cellular studies is done when the product name is reported on the F4000. No additional consent is required.…
Common Cell Therapy Related Questions
Data Collection and Quality » Cellular Therapy » Common Cell Therapy Related Questions
The recipient had a CAR-T infusion followed by an HCT. I see cell therapy forms with the HCT event date, is this correct? What you are seeing is “combined follow-up”. The intent of “combined follow-up” (when a recipient receives both an HCT and…
CIBMTR Guidance Document for Reporting Autologous Cellular Therapies
Data Collection and Quality » Cellular Therapy » CIBMTR Guidance Document for Reporting Autologous Cellular Therapies
Please consider the following guidance when determining whether to report a cellular therapy to CIBMTR. The scope of this document covers autologous cellular therapies only. Reporting autologous cellular therapy data to CIBMTR Reporting of autologous cellular…
Combined-Follow Up Scenarios (HCT + CT (Genetically Modified))
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified))
As of the Summer 2020 Release, CIBMTR implemented a hard stop when reporting multiple genetically modified cellular therapies and HCTs that require follow-up forms. This new functionality has been implemented to reduce center reporting burden and redundancies when…
Discrepancy: HCT Not Reported (Between NMDP and FormsNet3)
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: HCT Not Reported (Between NMDP and FormsNet3)
NMDP has a record of a product that was provided to a center. The infusion may exist in FormsNet3, but the infusion dates between FormsNet3 and NMDP are more than 10 days apart. Steps to Follow to Correct Discrepancy If the infusion did NOT occur, submit a CIMBTR…
Cell Therapy Reporting Tracks and Follow-Up Schedules
Data Collection and Quality » Cellular Therapy » Cell Therapy Reporting Tracks and Follow-Up Schedules
Beginning in July of 2023, a reporting track will now be set for all cell therapy CRIDs reported to CIBMTR. The track will be set by the center reporting preference and infusion type. *TED vs CRF reporting for cellular therapy was launched in the Summer 2023 release.…
Forms 2003, 2004, 2005, 2006, 4003
Data Collection and Quality » How Forms Come Due » HCT » Forms 2003, 2004, 2005, 2006, 4003
Gene Therapy Product (Form 2003) Infectious Disease Markers (Form 2004) Confirmation of HLA Typing (Form 2005) Hematopoietic Stem Cell Transplant (HCT) Infusion (Form 2006) Cellular Therapy Product (Form 4003) The following tables display how the 2004, 2005, and 2006…
How Forms Come Due
Data Collection and Quality » Cellular Therapy » How Forms Come Due
There are four scenarios for how cellular therapy forms come due: Cellular therapy, stand alone (no HCT forms) Co-infusion (with HCT) Post-HCT cellular therapy (not genetically modified) Post-HCT cellular therapy (genetically modified) Continue to view the…
2814: Indication for CRID Assignment
FormsNet3 Process and Tool Instructions » 2814: Indication for CRID Assignment
The Indication for CRID Assignment (Form 2814) collects information to initiate CIBMTR reporting on appropriate research or data collection forms. This form must be completed for the first indication requiring the individual to register for a CIBMTR Research ID (CRID).…
How Forms Come Due
Data Collection and Quality » How Forms Come Due
When first registering a patient with CIBMTR, the center must complete a CIBMTR Research ID (CRID) Assignment (2804) in FormsNet3, which generates a unique identifier for the patient. Once a CRID is assigned, the Consent Tool and Indication for CRID Assignment Form…
Q1-2: Indication
FormsNet3 Process and Tool Instructions » 2814: Indication for CRID Assignment » Q1-2: Indication
*Gene Therapy: If the infusion type is a gene therapy, the recipient will be placed on the HCT CRF track. Question 1: What is the indication for CIBMTR Research ID (CRID) assignment? Indicate whether the individual will be receiving hematopoietic cellular transplant…
Myeloproliferative Neoplasms (MPN)
Data Collection and Quality » Primary Disease and Disease Forms Due » Myeloproliferative Neoplasms (MPN)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Chronic neutrophilic leukemia (165) Chronic eosinophilic leukemia, not otherwise specified (NOS) (166) Essential thrombocythemia…
Chronic myelogenous leukemia (CML)
Data Collection and Quality » Primary Disease and Disease Forms Due » Chronic myelogenous leukemia (CML)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Not Applicable Forms 2012 &2112 No disease insert required
NHL-Waldenstrom
Data Collection and Quality » Primary Disease and Disease Forms Due » NHL-Waldenstrom
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173) Forms 2019 & 2119 No disease insert required
Hemoglobinopathies
Data Collection and Quality » Primary Disease and Disease Forms Due » Hemoglobinopathies
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Sickle cell disease (356) Forms 2030 & 2130 No disease insert required Transfusion dependent thalassemia (360) Other hemoglobinopathy (359) No…
Inherited abnormalities of platelets
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited abnormalities of platelets
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Congenital amegakaryocytosis / congenital thrombocytopenia (501) Forms 2035 & 2135 No disease insert is required Glanzmann thrombasthenia (502) Other…
Inherited Bone Marrow Failure Syndromes
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited Bone Marrow Failure Syndromes
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Diamond-Blackfan anemia (pure red cell aplasia) (312) Dyskeratosis congenita (307) Severe congenital neutropenia (including Kostmann syndrome) (460) Shwachman-Diamond…
Aplastic Anemia
Data Collection and Quality » Primary Disease and Disease Forms Due » Aplastic Anemia
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Acquired severe aplastic anemia, not otherwise specified (301) Acquired AA secondary to chemotherapy (313) Acquired SAA secondary to hepatitis (302) Acquired AA…
Hodgkin Lymphoma
Data Collection and Quality » Primary Disease and Disease Forms Due » Hodgkin Lymphoma
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Nodular lymphocyte predominant Hodgkin lymphoma (155) Lymphocyte-rich (151) Nodular sclerosis (152) Mixed cellularity (153) Lymphocyte depleted…
Disorders of the immune system
Data Collection and Quality » Primary Disease and Disease Forms Due » Disorders of the immune system
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Adenosine deaminase (ADA) deficiency / severe combined immunodefiency (SCID)(401) Absence of T and B cells SCID (402) Absence of T, normal B cell SCID (403) Omenn…
Myelodysplastic (MDS)
Data Collection and Quality » Primary Disease and Disease Forms Due » Myelodysplastic (MDS)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Atypical chronic myeloid leukemia (aCML), BCR-ABL1 (1440) Chronic myelomonocytic leukemia (CMMoL) (54) Myelodysplastic syndrome / myeloproliferative…
Histiocytic disorders
Data Collection and Quality » Primary Disease and Disease Forms Due » Histiocytic disorders
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Hemophagocytic lymphohistiocytosis (HLH) (571) Form 2039 & 2139 No Disease Insert Required Langerhans cell histiocytosis (histiocytosis-X)…
Multiple Myeloma/Plasma Cell Disorder (PCD)
Data Collection and Quality » Primary Disease and Disease Forms Due » Multiple Myeloma/Plasma Cell Disorder (PCD)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Multiple myeloma (178) Multiple myeloma-light chain only (186) Multiple myeloma non-secretory (187) Plasma cell leukemia (172) Solitary plasmacytoma…
Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Data Collection and Quality » Primary Disease and Disease Forms Due » Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Blastic plasmacytoid dendritic cell neoplasm (296) Acute undifferentiated leukemia (31) Mixed phenotype acute leukemia (MPAL) with…
Other Leukemia
Data Collection and Quality » Primary Disease and Disease Forms Due » Other Leukemia
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Chronic lymphocytic leukemia (CLL), NOS (34) Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) Form 2013 & 2113…
Inherited disorders of metabolism
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited disorders of metabolism
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Osteopetrosis(malignant infantile osteopetrosis) (521) Forms 2036 & 2136 No disease insert required Leukodystrophies Metachromatic leukodystrophy…
Inclusion Criteria
Transplant Center Specific Analysis (TCSA) » Inclusion Criteria
TCSA Inclusion Criteria Inclusion criteria for this dataset are based on center activity and patient characteristics. For a transplant to be included, it must be a patient’s first allogeneic transplant, it must have been given at a U.S. or select international…
Discrepancy: Missing CRID
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: Missing CRID
FormsNet3 does not have a record of the CRID on the CTA list. Steps to Follow to Correct Discrepancy Confirm correct CRID is reported on the CTA list. If the CTA list has an error, make corrections to the CTA list and resubmit via a CIBMTR Center Support…
PHI
Public Health Authority and Protected Health Information » PHI
Protected Health Information (PHI) and the CIBMTR Research ID (CRID) In order to create a universal unique ID system, CIBMTR collects protected health information (PHI), including but not limited to identifiers such as name, social security number (SSN), mother’s…
Quarterly Form Revision Schedule
Data Collection and Quality » Quarterly Form Revision Schedule
The following forms are currently being revised/developed. Check back for new forms, and updates to the anticipated release dates. Full details regarding the revisions (e.g. new questions, modified questions, removed questions) are located on the CIBMTR Portal.…
Autoimmune diseases
Data Collection and Quality » Primary Disease and Disease Forms Due » Autoimmune diseases
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Multiple sclerosis Multiple sclerosis (602) Form 2043 & 2143 No disease insert required Connective tissue diseases Systemic sclerosis (scleroderma)…
Acute myelogenous leukemia (AML or ANLL)
Data Collection and Quality » Primary Disease and Disease Forms Due » Acute myelogenous leukemia (AML or ANLL)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required AML with recurrent genetic abnormalities AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2A (5) AML with t(6;9) (p23;q34.1); DEK-NUP214 (6) AML with inv(3)…
2804: CIBMTR Research ID Assignment
FormsNet3 Process and Tool Instructions » 2804: CIBMTR Research ID Assignment
The CIBMTR Research ID (CRID) is a unique identifier assigned when an individual is registered with CIBMTR as receiving a cellular therapy, including hematopoietic stem cell transplant (HCT), cellular therapy (CT), treatment for marrow toxic injuries, or certain…
Acute lymphoblastic leukemia (ALL)
Data Collection and Quality » Primary Disease and Disease Forms Due » Acute lymphoblastic leukemia (ALL)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required B-lymphoblastic leukemia / lymphoma B-lymphoblastic leukemia / lymphoma, NOS (B-cell ALL, NOS) (191) B-lymphoblastic leukemia / lymphoma with…
Solid Tumors
Data Collection and Quality » Primary Disease and Disease Forms Due » Solid Tumors
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Breast cancer (250) No disease insert required No disease insert required Lung, small cell (202) Lung, non-small cell…
Allo_Unrelated Donor (Non-NMDP)
Data Collection and Quality » How Forms Come Due » HCT » Forms 2003, 2004, 2005, 2006, 4003 » Allo_Unrelated Donor (Non-NMDP)
For each Non-NMDP Unrelated instance, Form 2004 Form 2005 Form 2006 or 4003 CRF track Was the donor used for a prior HCT = yes X X (For each product) CRF track Was the donor used for a prior HCT = no X…
Fee Schedule
Fee Schedule
Fee Schedule for Forms Completion CIBMTR pays transplant centers for all completed Comprehensive Report Forms and Cellular Therapy Forms. Reporting of TED level data is not compensated, with the exception of the Form 2006 when requested for recipients on the TED…
Welcome
Welcome
CIBMTR Data Management Guide The Data Management Guide contains information on center participation and data submission to CIBMTR and serves as a resource for individuals seeking guidance about forms due, data quality, and the functions of CIBMTR research data…
Observational Database
Protocols and Consents » Observational Database
When a recipient consents to participate in research, their data are contained in the CIBMTR’s Observational Database. The database includes recipient baseline and outcome data for related and unrelated allogeneic transplants or other cellular therapy from any cell…
Primary Disease and Disease Forms Due
Data Collection and Quality » Primary Disease and Disease Forms Due
This section is useful for determining which disease inserts should be completed for the disease reported on a recipient’s Disease Classification Form 2402. The disease insert should appear in FormsNet for those on the CRF track after the Pre-TED Form 2400 and…
Research Sample Repository
Protocols and Consents » Research Sample Repository
The Research Sample Repository contains blood samples from unrelated recipients and/or their adult volunteer donor, or cord blood unit. Related allogeneic recipients and/or donors will participate at selected transplant centers. The primary objective of the Research…
Monthly Maintenance Items for FormsNet3
Data Collection and Quality » Monthly Maintenance Items for FormsNet3
Each month the FormsNet3 team makes updates to validations, question enabling/disabling and form generation. The monthly maintenance updates are tentatively scheduled for the 4th Friday of the month. February 2024 (released February 23rd, 2024) Form_Revision…
Allo- NMDP Donor
Data Collection and Quality » How Forms Come Due » HCT » Forms 2003, 2004, 2005, 2006, 4003 » Allo- NMDP Donor
For each NMDP Donor instance, regardless of: HCT type (ALLO_U, ALLO_R) Product Type (PBSC, BM, CBU) Form Track (TED, CRF) F2400 ‘Was this donor used for any prior HCTs’ (Yes, No) a F2006 will come due. *On the Pre-TED (F2400), questions will…
Data Collection and Quality
Data Collection and Quality
CIBMTR, in collaboration with the worldwide hematopoietic cell transplantation community, developed appropriately organized forms to capture a standard set of data elements for all transplant recipients. These forms are revised as needed to match the evolving science…
FormsNet3 Consent Tool
FormsNet3 Process and Tool Instructions » FormsNet3 Consent Tool
Recipient consent for the CIBMTR research database (ClinicalTrials.gov Identifier: NCT01166009) is collected in the Consent Tool within FormsNet3. The Consent Tool allows recipient consent status and contact information to be collected as soon as possible after the…
Allo_Related Donor (Non-NMDP)
Data Collection and Quality » How Forms Come Due » HCT » Forms 2003, 2004, 2005, 2006, 4003 » Allo_Related Donor (Non-NMDP)
For each Related Donor instance, where F2400 ‘Was this donor used for any prior HCTs’ = No Related Donor type: Syngeneic (monozygotic twin) or HLA-Identical Sibling Form 2004 Form 2005 Form 2006 or 4003 CRF track X …
Acronyms
Acronyms
AA: African American ABil: Acute biphenotypic leukemias AC: apheresis center ACCME: Accreditation Council for Continuing Medical Education AFA: Anti-fungal agent AGNIS: A Growable Network Information System ALL: Acute lymphoblastic leukemia, acute lymphocytic…
Step 2: US Centers – Submit CTA List to CIBMTR
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 2: US Centers – Submit CTA List to CIBMTR
In order to remain in Good Standing for CPI, centers must submit a list of all reportable infusions performed at their center in the previous calendar year by the end of Trimester 1 (April 30th). This requirement is not eligible for exemption. Process for Submitting…
Step 1: Report Infusions in FormsNet3
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 1: Report Infusions in FormsNet3
Centers must register new patients in FormsNet3 within 30 days of their first infusion. Reporting Requirements US Centers The US Government requires all US Centers to report allogeneic related and unrelated donor HCTs performed at their center, regardless of…
CPI Forms and Due Dates
Continuous Process Improvement Program (CPI) » Form Completion Standards » CPI Forms and Due Dates
!Adjusted Form Due Date: The form due date will automatically recalculate if the new form added is more than four months past its original form due date. The adjusted due date will be the date the form was created minus four months. The FormsNet3 Forms Grid will…
Step 2: International Centers – Submit CTA List to CIBMTR
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 2: International Centers – Submit CTA List to CIBMTR
In order to remain in Good Standing for CPI, centers must submit a list of all reportable infusions performed at their center in the previous calendar year by the end of Trimester 1 (June 30th). This requirement is not eligible for exemption. Process for Submitting…
Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data
Discrepancy Process During trimester 2, CIBMTR will generate and post a refreshed CTA discrepancy file (see preview below) on the CIBMTR Portal for centers to download every Friday How to download CTA files Centers need to review and resolve the discrepancies…
Non-Hodgkin Lymphoma
Data Collection and Quality » Primary Disease and Disease Forms Due » Non-Hodgkin Lymphoma
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required B-cell neoplasms ALK+ large B-cell lymphoma (1833) B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin…
Quick Links
Quick Links
CIBMTR and NMDP AGNIS NMDP Official Website CIBMTR Website Forms Instruction Manual Retired Manuals Traxis Adding/Removing Center Personnel Data Collection Forms List Retired Forms List CIBMTR Portal Additional Resources: Bone Marrow Donors Worldwide HRSA – Bone…
Consecutive Transplant Audit (CTA)
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA)
Each year CIBMTR performs a consecutive transplant audit (CTA) for all active centers to ensure the epidemiological integrity of the CIBMTR outcomes registry and to provide the US government with an accurate assessment of transplant activity. The audit ensures all…
3+ events
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified)) » 3+ events
These flowcharts show how forms come due when the recipient receives three or more infusions.
Q1-10: Consent Information
FormsNet3 Process and Tool Instructions » FormsNet3 Consent Tool » Q1-10: Consent Information
Question 1: Consent status for submitting research data to CIBMTR !To be compliant with Federal Regulation for human research protection, centers must obtain IRB-approved informed consent from recipients and donors (if applicable, for the related donor sample…
International Centers
Protocols and Consents » International Centers
International Centers – Institutional Review Board (IRB) Approval International transplant centers must follow their country’s laws and regulations governing human subjects and privacy protection. The transplant center is responsible for obtaining the…
Regulatory Documentation Standards
Continuous Process Improvement Program (CPI) » Regulatory Documentation Standards
Data Transmission and IRB Documentation CIBMTR cannot reimburse for Comprehensive Report Forms (CRFs) until it has a current, signed Data Transmission Agreement (DTA) or Master Healthcare Data (MHA) and Sample Submission Agreement is on file. The DTA or MHA permits…
Overview & Timeline
Transplant Center Specific Analysis (TCSA) » Overview & Timeline
What is TCSA? Transplant Center Specific Analysis (TCSA), also referred to as Center Specific Analysis (CSA) or Center Outcomes Analysis, is used to predict one-year survival of first allogeneic transplants, based on data reported to CIBMTR. This program is mandatory…
Determining Reporting Levels: US Centers
Center Participation » Determining Reporting Levels: US Centers
For US centers, the Center Participation Status with NMDP and CIBMTR programs will determine the allowable reporting levels and the subsequent data collection forms the transplant center will be required to submit to the CIBMTR. This designation will inform the CPI…
Determining Reporting Levels: International Centers
Center Participation » Determining Reporting Levels: International Centers
For international centers, the Center Participation Status with NMDP and CIBMTR programs will determine the allowable reporting levels and the subsequent data collection forms the transplant center will be required to submit to the CIBMTR. This designation will inform…
International Information
Transplant Center Specific Analysis (TCSA) » International Information
Beginning in 2025, the program will open to international centers. Participation in this project is voluntary for international centers. Complete information for variables used in the multivariate analysis is essential to produce a valid report. If a center has…
Autologous
Data Collection and Quality » How Forms Come Due » HCT » Forms 2003, 2004, 2005, 2006, 4003 » Autologous
For each Autologous instance, Form 2003 (Gene Therapy) Form 2004 Form 2005 Form 2006 or 4003 TED or CRF track Genetically modified = yes X X (F4003 only) TED or CRF track Product Type = Cord Blood…
Center Participation
Center Participation
Center Status Level Assignment The Stem Cell Therapeutic Outcomes Database (SCTOD) is part of the C.W. Bill Young Cell Transplantation Program (Program), authorized by the Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129) and reauthorized by the Stem…
FormsNet3
Data Collection and Quality » FormsNet3
More than 95% of data collected by the CIBMTR is submitted electronically via FormsNet3, a comprehensive electronic data capture system containing greater than 250 forms related to the capturing of HCT outcomes for donors and recipients. The FormsNet3 application is…
Frequently Asked Questions (FAQ)
Center Volume Data Reports (CVDR) » Resources » Frequently Asked Questions (FAQ)
How will CIBMTR inform my center the CVDR Portal is open and dataset ready for review? An eBlast announcement will be distributed to centers informing them of the dates the CIBMTR CVDR dataset/portal will be open and available for review. When should I review my…
Additional Forms
Data Collection and Quality » How Forms Come Due » Additional Forms
Data reported on CIBMTR forms may trigger additional forms to come due. Examples of these forms include, but are not limited to Infection forms (e.g. Fungal Infection Forms 2046/2146) Study specific forms (e.g. 2500 series) Veno-Occlusive Disease/Sinusoidal…
US Transplant Centers
Protocols and Consents » US Transplant Centers
United States Transplant Centers – Institutional Review Board (IRB) Approval: To be compliant with United States Federal Regulations for human research subject protection, transplant centers must obtain IRB-approved informed consent from recipients to allow data…
Adverse Event and Product Complaint Reporting
Data Collection and Quality » NMDP Forms » Adverse Event and Product Complaint Reporting
NMDP requires transplant centers to report all qualifying recipient adverse events and/or product complaint events on all recipients of cellular product that we facilitate. FormsNet3 is a system used by the Event Reporting System (ERS) to capture information about…
Overview & Timeline
Center Volume Data Reports (CVDR) » Overview & Timeline
Overview Annually, as part of our contract with the U.S. Health Resources and Services Administration (HRSA), CIBMTR publishes transplant center volumes data on the C.W. Bill Young Cell Transplantation Program government website. The hematopoietic cell transplantation…
Public Health Authority and Protected Health Information
Public Health Authority and Protected Health Information
Public Health Authority (PHA) Status CIBMTR meets the U.S. Department of Health & Human Services HIPAA Privacy Rule’s definition of a public health authority (PHA) and is authorized by law to collect the information necessary to fulfill the legislated mandate to…
Section 2: Completed by transferring FROM center
FormsNet3 Process and Tool Instructions » Recipient Transfer Tool » Section 2: Completed by transferring FROM center
Section 2 of the recipient transfer tool is completed by the center the recipient is transferring FROM. !The TO center and FROM center should be in contact with one another prior to completing the Recipient Transfer to ensure that both centers are referring to the…
Discrepancy: DOB (Date of Birth) Mismatch
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: DOB (Date of Birth) Mismatch
The patient’s date of birth is discrepant between FormsNet3 and the CTA list. Steps to Follow to Correct Discrepancy If the CTA list is incorrect, centers should correct the CTA list and resubmit via a CIBMTR Center Support ticket. After navigating to…
Discrepancy: Sex Mismatch
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 1: Resolve Discrepancies Between CTA List and FormsNet3/NMDP Operations Data » Discrepancy: Sex Mismatch
The patient’s sex is discrepant between FormNet3 and the CRA list. Steps to Follow to Correct Discrepancy If the CTA list is incorrect, centers should correct the CTA list and resubmit via a CIBMTR Center Support ticket. After navigating to the CIBMTR…
Continuous Process Improvement Program (CPI)
Continuous Process Improvement Program (CPI)
Introduction CIBMTR has established processes to assess and close any gaps that exist in data reported to the C.W. Bill Young Cell Transplantation Program (CWBYCTP). The assessment covers unrelated donor transplants facilitated by the CWBYCTP, both within the US and…
Q19-22: Outcomes Registry Reporting
FormsNet3 Process and Tool Instructions » 2804: CIBMTR Research ID Assignment » Q19-22: Outcomes Registry Reporting
Indicate and provide identifiers for all other outcomes registries the individual’s data are being reported to. If the individual’s data are not being reported to any other outcomes registries, continue with the signature section of the form. If the individual’s…
Legacy Error Corrections
Data Collection and Quality » Correcting Historical Data » Legacy Error Corrections
How to make changes to Legacy Data “Legacy data” are data submitted to CIBMTR or NMDP before the FormsNet2 application became available on December 3, 2007. If you need to make changes to data that were submitted to the legacy databases, please send an error…
Section 1: Completed by transferring TO center
FormsNet3 Process and Tool Instructions » Recipient Transfer Tool » Section 1: Completed by transferring TO center
Section 1 of the recipient transfer tool is completed by the center where the recipient is transferring TO. !The TO center and FROM center should be in contact with one another prior to completing the Recipient Transfer to ensure that both centers are referring to the…
FormsNet3
Access to CIBMTR Systems » FormsNet3
Obtaining Access For a FormsNet3 user, once the account is created, the person must also be assigned an application user role in FormsNet3. Without a role, the user will not be associated with a center and will be unable to access the Recipient tab in the FormsNet3…
Status Submission
Center Volume Data Reports (CVDR) » Status Submission
CIBMTR allows centers to review data, suggest changes, and submit publishing preference. CIBMTR will then close the Portal (to refresh the dataset) and allow the centers one last opportunity to view the refreshed data. Any corrections to data submitted through…
Correcting Historical Data
Data Collection and Quality » Correcting Historical Data
With the release of FormsNet3, all corrections to Legacy Data (submitted prior to FormsNet2) and FormsNet2 forms that aren’t FormsNet3 editable, need to be sent via Paper Error Corrections. Data entered into FormsNet3 (since 12/4/12) or on FormsNet3 editable…
Center Compliance
Continuous Process Improvement Program (CPI) » Center Compliance
Compliance Monitoring Centers should monitor their compliance to the CPI requirements throughout the trimester. The form completion categories are important to monitor as the total number of forms needed to meet the targets will fluctuate throughout the trimester.…
Age of Majority FAQ
Protocols and Consents » Consent: Age of Majority » Age of Majority FAQ
When is reconsent required? Age of majority reconsent will be continuously required for all participants enrolled to the CIBMTR Research Outcomes Database Protocol under minor consent. Centers under the oversight of the NMDP IRB are required to follow the NMDP IRB’s…
Q1-13: Demographics
FormsNet3 Process and Tool Instructions » 2804: CIBMTR Research ID Assignment » Q1-13: Demographics
*This form must be completed for all individuals on whom data is submitted to CIBMTR. CIBMTR is a Public Health Authority (PHA) under the Health Insurance Portability and Accountability Act (HIPAA). In this capacity, CIBMTR is authorized to collect individually…