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 the CPI Program of the center’s selected level of participation.
Infusion Types
Allogeneic (Unrelated and Related) Infusions
All allogeneic HCTs performed using products collected in the U.S. require a minimum of Transplant Essential Data (TED) level data submission. If a recipient is participating in a clinical trial, Comprehensive Report Form (CRF) level data submission may be required (e.g. select BMT CTN trials, RCI BMT, etc.). In these cases, consent is included with the study protocol and that criteria will be used to select which reporting track will be required.
Autologous Infusions
Reporting autologous infusion data to CIBMTR is voluntary. A site may elect to report all autologous infusions to CIBMTR, or may choose to not report any infusions. However, if the site elects to report autologous infusions, they must report all autologous infusions performed.
Data Collection Forms
- Transplant Essential Data Forms (TED): data are used for evaluation of the Stem Cell Therapeutic Outcomes Database (SCTOD) program operations, including federally required research such as analyses of center-specific outcomes and evaluation of optimal registry and cord blood bank size.
- Comprehensive Report Forms (CRF): data are included in research studies, though TED-level data may occasionally be used. These forms collect more detailed data including disease assessments at each follow up visit, expanded Acute and Chronic GVHD data, engraftment data, etc.
Determining Reporting Levels
For each infusion type performed at the center, the Medical Director will be required to designate the CIBMTR reporting level (at the time of Member Center Set-Up) as defined below:
Allogeneic – Related Infusion:
Reporting Level Options (must select one)
- TED Only Center (will NOT be assigned to the CRF track for any recipient)
- CRF Eligible – Data reporting track assigned based on Research Algorithm
- Perform Infusions, but do not report to CIBMTR
- Do not perform Infusion type
Allogeneic – Unrelated Infusion:
Reporting Level Options (must select one)
- NMDP-Facilitated Infusions – If center is receiving products from NMDP, those infusions must be reported to CIBMTR
- TED Only Center (will NOT be assigned to the CRF track for any recipient)
- CRF Eligible – Data reporting track assigned based on Research Algorithm
- Perform Infusions, but do not report to CIBMTR
- Do not perform Infusion type
Autologous Infusion:
Reporting Level Options (must select one)
- TED Only Center (will NOT be assigned to the CRF track for any recipient)
- CRF Eligible- Data reporting track assigned based on Research Algorithm
- Perform Infusions, but do not report to CIBMTR
- Do not perform infusion type
Additional Clarifications
TED Only
Center reports all infusions of this type to CIBMTR, all cases assigned to TED follow-up track only.
- Forms include forms 2814, 2400, 2402, 2004, 2005, 2006, 2450, 2900, plus select event-based forms (e.g., F2149 to report COVID infection)
- Data may be used for research studies if patient consents to research participation
- Forms completed are not reimbursed, except for a few select forms (see Fee Schedule)
CRF Eligible
Center reports all infusions of this type to CIBMTR.
- Research algorithm assigns subset of all transplant recipients to CRF track
- Determined by variables such as consent, type of transplant, age, disease, etc.
- If not assigned to CRF track, recipient data will be reported on TED forms
- Forms completed are reimbursed – (see Fee Schedule)
Do Not Perform
This option should be selected if the site does not perform this infusion type.
Perform, Do Not Report
This option should be selected if the center performs this infusion type, but does not report the data to CIBMTR.
Research Algorithm
CIBMTR developed a weighted-randomization selection algorithm for CRF centers that determines which set of forms (TED versus CRF) is required for each HCT recipient. The algorithm randomly selects an epidemiologic sample of recipients for whom a CRF is to be requested. The algorithm includes, but is not limited to, type of HCT, age of the recipient, disease, etc. It gives higher weights to patients receiving HCT for rare indications, to very young and very old patients, and novel treatment approaches. It aims to provide representative, adequately sized subsets of patients for studies requiring detailed data. The algorithm is periodically reviewed to assess the burden of data submission for centers. If a recipient consents to participate in research, the algorithm determines the HCT follow-up data submission level: Post-TED forms or the CRFs. If an allogeneic recipient does not consent to participate in research, then the algorithm is not used, and HCT follow-up data must be submitted on the Post-TED form.