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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…
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…
Generating a CPI Center Forms Due Report
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Center Forms Due Tool » Generating a CPI Center Forms Due Report
Step 1: Status codes – Click on the Step 2: Forms – Click on the Step 3: Click on US CPI or Non-US CPI (should auto-populate) Step 4: The Date Type will auto-populate to Form Due Date. Critical Forms Due On Time Forms Due during…
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…
CPI Resources
Continuous Process Improvement Program (CPI) » CPI Resources
CIBMTR has created the following CPI resources to further support centers with the CPI compliance program. These tools can be utilized for workflow management, analysis, metrics and more. Please let CIBMTR know if any additional resources would be beneficial. Use the…
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…
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…
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…
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.…
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…
Determining CPI Metrics from Center Forms Due Tool
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Center Forms Due Tool » Determining CPI Metrics from Center Forms Due Tool
*Equation: (total forms) x (% form requirement) = (forms to complete to meet requirement) – (forms completed) = (additional forms to complete to meet requirement) Step 1: Once the number of center forms due (in the desired category) has been determined using…
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
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…
Posting
Transplant Center Specific Analysis (TCSA) » Posting
Public Posting: HRSA Transplant Outcomes The data posted by Health Resources and Service Administration (HRSA), known as Transplant Outcomes, includes reports of patient outcomes and other information about transplants. Transplants in these reports were performed at…
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…
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).…
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…
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…
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…
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…
Forms Completion List
Corporate Studies and Registries » Forms Completion List
CIBMTR Corporate Studies and Registries Forms Completion List The Corporate Studies and Registries Forms Completion List is automatically sent the first Tuesday of the month via email. If you have questions about forms in these reports, contact CIBMTR Center…
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…
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…
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…
CPI Center Forms Due Tool
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Center Forms Due Tool
A real-time report can be run to generate a list of CPI forms due any time using the Center Forms Due tool. Under Recipient tab, select Center Forms Due from the Menu bar. For generalized instructions on creating a Forms Due list, please visit Recipient Center Forms…
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 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…
Forms Due List
Corporate Studies and Registries » Forms Due List
CIBMTR Corporate Studies and Registries Forms Due List The Corporate Studies and Registries Forms Due List is automatically sent each Tuesday via email. If you have questions about forms in these reports, contact CIBMTR Center Support. Your center will receive this…
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…
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…
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…
Survival Form Status
Data Collection and Quality » FormsNet3 » Survival Form Status
When you have a patient that is further out from transplant, you know is alive and all efforts to obtain follow-up data on a patient have failed, you can report the recipient’s latest alive date of contact, thus eliminating the need to override multiple questions…
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…
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…
Q6–21: Recipient Contact Information
FormsNet3 Process and Tool Instructions » 2820: Recipient Contact Information » Q6–21: Recipient Contact Information
Question 6 – 7: First Name, Last Name Report the recipient’s complete legal first name in question 1 and complete legal last name in question 2. Question 8: Indicate language preference: Select the recipient’s primary language preference. If the…
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…
Q22–38: Parent / Legal Guardian Contact Information
FormsNet3 Process and Tool Instructions » 2820: Recipient Contact Information » Q22–38: Parent / Legal Guardian Contact Information
Question 22 – 23: First Name, Last Name Report the complete legal first name of the recipient’s parent / legal guardian in question 22 and complete legal last name in question 23. Question 24: Indicate language preference Select the parent / legal…
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…
Q1-2: Reason(s) for the Infusion Cancellation or Delay
FormsNet3 Process and Tool Instructions » 2008: Infusion Canceled or Delayed » Q1-2: Reason(s) for the Infusion Cancellation or Delay
Question 1. Specify the reason(s) for the infusion cancellation or delay (Check all that apply) Specify the reason(s) why the infusion was cancelled or delayed. Select all that apply. If the reason why the infusion was canceled or delayed is not listed on the form,…
Q39–58: Alternate Contact Information
FormsNet3 Process and Tool Instructions » 2820: Recipient Contact Information » Q39–58: Alternate Contact Information
This section will enable when a specific study requires an alternate contact, such as a caregiver, who is not the recipient’s parent / guardian. This section is currently disabled as it is not required for the following studies: BMT CTN 1702, BMT CTN 1703, or BMT CTN…
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…
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…
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…
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…
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…
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…
CIBMTR Portal
Access to CIBMTR Systems » CIBMTR Portal
Obtaining Access Access to the CIBMTR Portal will also be set up based on the submission of the account creation request in the Network Partner Portal. The Primary Data Manager is the person responsible for creating an account for the individual CIBMTR Portal users in…
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…
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…
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…
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…
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.…
Recipient Transfer Best Practices
FormsNet3 Process and Tool Instructions » Recipient Transfer Tool » Recipient Transfer Best Practices
I have received a transfer request; how quickly do I need to respond? Please respond to a transfer request within two weeks. Requests will appear on the FormsNet3 homepage and via email notification. It is very important to not delay a transfer so that centers have…
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…