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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 …
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Discrepancy: RID Not Reported in FormNet3
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: RID Not Reported in FormNet3
The patient’s NMDP RID is not reported in FormsNet3. This could be due to NMDP RID blank in the CRID Assignment tool NMDP RID in the CRID Assignment tool is incorrect CRID has not yet been assigned in FormsNet3 Steps to Follow to Correct…
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…
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…
Step 3: CTA Discrepancy Process
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process
In order to remain in Good Standing for CPI, centers must address all discrepancies between the provided CTA list and the data reported to FormNet3 by the end of Trimester 2 (August 31st for US centers, October 31st for International centers). This requirement is not…
User Updates
Access to CIBMTR Systems » Network Partner Portal » User Updates
Creating a New User From the Select Your Center field, choose the center from the dropdown the new user will be associated with. In the Select New User’s Role field, select the appropriate job role for your new user. Next to each role is a short description of…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Network Partner Portal Role Reference Guide
Access to CIBMTR Systems » Network Partner Portal » Network Partner Portal Role Reference Guide
Center Type Role Name Description of New Role Software RC Primary Data Manager Access to FormsNet3, CIBMTR Portal, CIBMTR Center Support and the Network Partner Portal. Individual responsible for managing activities to meet NMDP…
Contact Us
Contact Us
NMDP Service Desk at (612) 362-3411 or (800) 526-7809 Ext. 3411 Submit a question and/or issue via CIBMTR Center Support, our customer service portal If you do not have an account for CIBMTR Center support, please email centersupport@nmdp.org to create a…
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…
Network Partner Portal
Access to CIBMTR Systems » Network Partner Portal
!This information is specific to the Primary Data Manager or Medical Director role. To get someone access to CIBMTR systems (FormsNet3, the CIBMTR Portal, and CIBMTR Center Support) the Primary Data Manager will need to add an account in the Network Partner…
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…
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…
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…
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…
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…
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…
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…
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…
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 …
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.…
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…