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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…
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…
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…
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…
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…
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…
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…
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…
Determining Total # of CPI Forms Due in a Trimester
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Center Forms Due Tool » Determining Total # of CPI Forms Due in a Trimester
Determine the number of “Critical Forms On-time” that are DUE and COMPLETED Critical Forms On-Time (Due) Critical Forms On-Time (Completed) Step 1: Status Codes – Click on the Step 1: Status codes – Click on…
Additional Forms
Data Collection and Quality » How Forms Come Due » Additional Forms
Data reported on CIBMTR forms may trigger additional forms to come due. Examples of these forms include, but are not limited to Infection forms (e.g. Fungal Infection Forms 2046/2146) Study specific forms (e.g. 2500 series) Veno-Occlusive Disease/Sinusoidal…
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…
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…
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…
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…
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, 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). …
Part 2: Resolve Discrepancies within FormsNet3 Forms (Query Resolution)
Continuous Process Improvement Program (CPI) » Consecutive Transplant Audit (CTA) » Step 3: CTA Discrepancy Process » Part 2: Resolve Discrepancies within FormsNet3 Forms (Query Resolution)
Discrepancy Process (Queries) Once the CTA discrepancies have been resolved, CIBMTR will place queries on FormsNet3 forms containing discrepancies. A list of these queries will be uploaded to the CIBMTR Portal. How to download CTA files Centers will need to…
Determining Total # of CPI Forms Completed in a Week
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Center Forms Due Tool » Determining Total # of CPI Forms Completed in a Week
Step 1: Status codes – Click on “AUD, CMP, LCK, QRY, and PND” (These are the form statuses that are considered “complete for CPI”) Step 2: Forms – Click on the Step 3: The Date Type will auto-populate to equal Form Due Date.…
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…
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…
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…
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…
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…
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.…
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…
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…
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…
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…
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).…
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…
HCT
Data Collection and Quality » How Forms Come Due » HCT
When the indication is reported as HCT for the patient’s first event, or an HCT is reported on an HCT or cellular therapy follow-up form, the Pre-TED Forms 2400 and 2402 will be the first to come due. Once the Pre-TED forms are complete and the data are processed,…
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…
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…
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 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.…
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…
Marrow Toxic Injury
Data Collection and Quality » How Forms Come Due » Marrow Toxic Injury
When the indication is reported as marrow toxic injury, the RITN Baseline Form 5000, RITN Contact Form 5001, and RITN Follow-Up Forms will come due. Note: Marrow toxic injury should only be reported as an indication by participating Radiation Injury Treatment…
CPI Exemption Request
Continuous Process Improvement Program (CPI) » CPI Resources » CPI Exemption Request
CIBMTR acknowledges a site may have difficulty achieving CPI requirements in a given trimester due to extenuating circumstances, such as staff shortages/turnover, or other unforeseen challenges. To assist sites in meeting CPI requirements in these difficult situations,…
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…
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,…
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…
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…
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).
3+ events
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified)) » 3+ events
These flowcharts show how forms come due when the recipient receives three or more infusions.
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…
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.
2820: Recipient Contact Information
FormsNet3 Process and Tool Instructions » 2820: Recipient Contact Information
The Recipient Contact Information Form 2820 collects contact information on recipients who have agreed to be contacted directly by CIBMTR for the purpose of inviting them to participate in research activities. If the recipient is a minor, contact information for the…
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…
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…
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…
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…
HCT --> CT
Data Collection and Quality » Cellular Therapy » How Forms Come Due » Combined-Follow Up Scenarios (HCT + CT (Genetically Modified)) » HCT --> CT
This Visio flowchart shows how forms come due when the HCT is first and there is combined follow up for the subsequent cellular therapy. Questions disabled on HCT and CT forms Question F4100 F2450 (when TED level HCT F2100 (when CRF level HCT…
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…
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…
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…
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…
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…
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 …
Quarterly Form Revision Schedule
Data Collection and Quality » Quarterly Form Revision Schedule
The following forms are currently being revised/developed. Check back for new forms, and updates to the anticipated release dates. Full details regarding the revisions (e.g. new questions, modified questions, removed questions) are located on the CIBMTR Portal.…
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,…
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…
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…
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…
Disorders of the immune system
Data Collection and Quality » Primary Disease and Disease Forms Due » Disorders of the immune system
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Adenosine deaminase (ADA) deficiency / severe combined immunodefiency (SCID)(401) Absence of T and B cells SCID (402) Absence of T, normal B cell SCID (403) Omenn…
Correcting Historical Data
Data Collection and Quality » Correcting Historical Data
With the release of FormsNet3, all corrections to Legacy Data (submitted prior to FormsNet2) and FormsNet2 forms that aren’t FormsNet3 editable, need to be sent via Paper Error Corrections. Data entered into FormsNet3 (since 12/4/12) or on FormsNet3 editable…
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…
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…
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…
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…
Discrepancy: DOB (Date of Birth) 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: DOB (Date of Birth) Mismatch
The patient’s date of birth 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…
Discrepancy: Sex 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: Sex Mismatch
The patient’s sex is discrepant between FormNet3 and the CRA 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…
Inherited disorders of metabolism
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited disorders of metabolism
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Osteopetrosis(malignant infantile osteopetrosis) (521) Forms 2036 & 2136 No disease insert required Leukodystrophies Metachromatic leukodystrophy…
Consent Tool Grids
FormsNet3 Process and Tool Instructions » FormsNet3 Consent Tool » Consent Tool Grids
There are three grids within the Consent Tool: The Recipient Information Grid: This grid is identical to the ‘Recipient Information’ grid found under the recipient forms. The only difference is that unscheduled forms cannot be generated from the Consent Tool,…
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…
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…
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 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…
Chronic myelogenous leukemia (CML)
Data Collection and Quality » Primary Disease and Disease Forms Due » Chronic myelogenous leukemia (CML)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Not Applicable Forms 2012 &2112 No disease insert required
NHL-Waldenstrom
Data Collection and Quality » Primary Disease and Disease Forms Due » NHL-Waldenstrom
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173) Forms 2019 & 2119 No disease insert required
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…
Overview & Timeline
Center Volume Data Reports (CVDR) » Overview & Timeline
Overview Annually, as part of our contract with the U.S. Health Resources and Services Administration (HRSA), CIBMTR publishes transplant center volumes data on the C.W. Bill Young Cell Transplantation Program government website. The hematopoietic cell transplantation…
Hemoglobinopathies
Data Collection and Quality » Primary Disease and Disease Forms Due » Hemoglobinopathies
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Sickle cell disease (356) Forms 2030 & 2130 No disease insert required Transfusion dependent thalassemia (360) Other hemoglobinopathy (359) No…
Inherited abnormalities of platelets
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited abnormalities of platelets
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Congenital amegakaryocytosis / congenital thrombocytopenia (501) Forms 2035 & 2135 No disease insert is required Glanzmann thrombasthenia (502) Other…
Inherited Bone Marrow Failure Syndromes
Data Collection and Quality » Primary Disease and Disease Forms Due » Inherited Bone Marrow Failure Syndromes
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Diamond-Blackfan anemia (pure red cell aplasia) (312) Dyskeratosis congenita (307) Severe congenital neutropenia (including Kostmann syndrome) (460) Shwachman-Diamond…
Myelodysplastic (MDS)
Data Collection and Quality » Primary Disease and Disease Forms Due » Myelodysplastic (MDS)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Atypical chronic myeloid leukemia (aCML), BCR-ABL1 (1440) Chronic myelomonocytic leukemia (CMMoL) (54) Myelodysplastic syndrome / myeloproliferative…
Aplastic Anemia
Data Collection and Quality » Primary Disease and Disease Forms Due » Aplastic Anemia
Disease Subtype(s) HCT Disease Inserts Cellular Therapy Disease Inserts Acquired severe aplastic anemia, not otherwise specified (301) Acquired AA secondary to chemotherapy (313) Acquired SAA secondary to hepatitis (302) Acquired AA…
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 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…
Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Data Collection and Quality » Primary Disease and Disease Forms Due » Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Blastic plasmacytoid dendritic cell neoplasm (296) Acute undifferentiated leukemia (31) Mixed phenotype acute leukemia (MPAL) with…
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…
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…
Myeloproliferative Neoplasms (MPN)
Data Collection and Quality » Primary Disease and Disease Forms Due » Myeloproliferative Neoplasms (MPN)
Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required Chronic neutrophilic leukemia (165) Chronic eosinophilic leukemia, not otherwise specified (NOS) (166) Essential thrombocythemia…
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…
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…
Navigation to the Consent Tool
FormsNet3 Process and Tool Instructions » FormsNet3 Consent Tool » Navigation to the Consent Tool
The Consent Tool can be found by selecting the recipient tab and selecting consent tool. Then, search for the Consent Tool by entering the CRID in the search box. There are two additional ways to navigate to the Consent Tool (listed below): The Consent Tool can…
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…
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.…