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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.
2008: Infusion Canceled or Delayed
FormsNet3 Process and Tool Instructions » 2008: Infusion Canceled or Delayed
The Canceled or Delayed (2008) form is expected whenever an infusion was canceled or delayed indefinitely. To submit this form, use the Create Unscheduled Form icon in the appropriate infusion row on the Recipient Information Grid. In order for the Infusion Canceled or…
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,…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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).…
FormsNet3 Process and Tool Instructions
FormsNet3 Process and Tool Instructions
The FormsNet3 Process and Tool Instructions section contains information on the successful completion of the various FormsNet3 tools. Contents of this section: 2804: CIBMTR Research ID Assignment FormsNet3 Consent Tool 2814: Indication for CRID Assignment Recipient…
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…
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…
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…
Q1-2: 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…
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…
FormsNet2 Paper EC Process
Data Collection and Quality » Correcting Historical Data » FormsNet2 Paper EC Process
Error corrections for FormsNet2 versions of the forms are available on the Retired Forms page of CIBMTR’s website. Please make sure to use the correct version of the form that was completed for all FormsNet2 documents. The question number and sometimes entire…
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 …
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…
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).
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…
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…
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…
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…
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…
Completing Error Correction Forms
Data Collection and Quality » Correcting Historical Data » Completing Error Correction Forms
The banner box needs to be completed for each page. Provide the Sequence Number from the original form Provide the CRID, Infusion Date, and Center Number Today’s Date – is the date you are completing the EC Provide your initials in the…
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…
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…
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…
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.…
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 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…
Form Completion Standards
Continuous Process Improvement Program (CPI) » Form Completion Standards
CIBMTR has revised the CPI Form Completion Standards to better align the requirements with the data needs of the transplant community, as well as to simplify the metrics tracked to improve the quality and availability of research data. These updates will streamline the…
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…
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…
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.…
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…
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…
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…