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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…
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…
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 …
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Protocols and Consents
Protocols and Consents
Transplant centers are expected to approach all recipients for consent to participate in the Clinical Outcomes Research Database. Centers participating in the Research Sample Repository should approach all unrelated recipients, as well as all related donor/recipient…
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…
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…
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…
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…
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…
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…
Genetic Mutation Reporting
Data Collection and Quality » NMDP Forms » Genetic Mutation Reporting
NMDP has implemented a protocol consent change and is introducing a standardized way to report genetic mutations detected in donor-derived cells. Historically, the process to report findings has not been outlined and occurs on a case-by-case basis. By standardizing…
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…
Dataset
Center Volume Data Reports (CVDR) » Dataset
The CVDR report includes transplants from the past five years performed by domestic transplant centers. The variables in these reports include identifiers (CCN, center name, center city, center state, CRID, event date, and event year), recipient demographics…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Q1-5: Indication
FormsNet3 Process and Tool Instructions » 2820: Recipient Contact Information » Q1-5: Indication
Question 1: Did this Form 2820 become due because the recipient agreed to direct contact by CIBMTR for research studies as indicated on Form 2400? This question should be answered ‘yes’ if the recipient has given permission to be directly contacted by CIBMTR for…
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…
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…
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.…
Questions & Resources
Transplant Center Specific Analysis (TCSA) » Questions & Resources
For any TCSA related questions or concerns submit a CIBMTR Center Support ticket > TCSA. For more information visit: Center Specific Survival Analysis Methodology Center Specific Survival Analysis FAQ
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)…
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…
Corporate Studies and Registries
Corporate Studies and Registries
There are two lists related to CIBMTR Corporate Studies and Registries that are sent via email Forms Due List Forms Completion List These are automatically sent to current Primary Data Managers and staff we’ve been asked to copy on correspondence sent to the…
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,…
Creating Unscheduled Forms
Data Collection and Quality » How Forms Come Due » Additional Forms » Creating Unscheduled Forms
All data reporting to CIBMTR is managed through the FormsNet3 application. Although most CIBMTR data collection forms are automated in the FormsNet3 system, there are cases where needed form(s) may not come due as expected. To ensure timely reporting, the following…
CIBMTR CPI Summary Report
Continuous Process Improvement Program (CPI) » CPI Resources » CIBMTR CPI Summary Report
The Recipient CPI Summary Report is automatically sent to the current Primary Data Manager(s). Additional center managers can request to be added to the CIBMTR CPI Summary distribution list by contacting CIBMTR via a CIBMTR Center Support ticket. After navigating…
Q14-18: Recipient Identifiers
FormsNet3 Process and Tool Instructions » 2804: CIBMTR Research ID Assignment » Q14-18: Recipient Identifiers
Complete all additional individual identifiers, as applicable. Question 14: Recipient NMDP ID Report the seven-digit recipient ID (RID) assigned by NMDP. If the individual has never been assigned an NMDP RID, leave this data field blank. For RELATED donors, do not…
New User First Login Instructions
Access to CIBMTR Systems » Network Partner Portal » New User First Login Instructions
New User’s First Login to CIBMTR Systems When a new user account is created, the person will be able to log into CIBMTR systems approximately 90 minutes after the account request is completed. Not all applications will be available at that time. Reference the…
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…
Entering a New Consent for Age of Majority
Protocols and Consents » Consent: Age of Majority » Entering a New Consent for Age of Majority
Age of Majority Consent for the Research Database *Age of Majority Consent definition – each U.S. state has its own age of majority which is the legally defined age at which a person is considered an adult, with all the attendant rights and responsibilities of…