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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…
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…
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…
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…
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…
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…
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.…
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…
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.…
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…
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…
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,…
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…
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…
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…
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). …
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.…
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…
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…
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…
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…
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…
Online Training
Online Training
Educational opportunities are continually being developed as part of our commitment to improving data quality and providing resources for data managers for data reporting to the CIBMTR. CIBMTR Training has implemented eLearning modules for easily accessible training…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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).…
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…
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…
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…
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…