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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…
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…
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…
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…
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…
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…
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…
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…
Consent: Age of Majority
Protocols and Consents » Consent: Age of Majority
Age of Majority reconsent is a critical component of the informed consent process. CIBMTR is committed to ensuring that our participants’ right to consent is provided to them once they have reached their age of majority. The following subsections are available for…
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…
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…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
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…
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 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…
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…
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…
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…
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…
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…
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…