Center Participation Status with NMDP and CIBMTR programs will determine the subsequent data collection forms the transplant center will be required to submit to CIBMTR. This designation will inform the CPI Program of the center’s selected level of participation.
Infusion Types
Allogeneic (Related and Unrelated) Infusions
All allogeneic (related and unrelated) HCTs performed in the US require a minimum of TED level data submission, even if the recipient declines consent to the Observational Research Database. If a recipient is participating in a clinical trial, 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 HCT data to CIBMTR is required for BMT CTN member centers. For those centers not participating with BMT CTN, reporting autologous HCTs is voluntary. A site may elect to report all autologous HCTs to CIBMTR or may choose to not report any. However, if the site elects to report autologous HCTs, they must report all autologous HCTs performed.
Cellular Therapy Infusions
Reporting cellular therapy infusions to CIBMTR is voluntary.
Gene Therapy Infusions
Reporting gene therapy infusions to CIBMTR is voluntary.
Determining Reporting Levels
CIBMTR forms provide two different levels of reporting, the Transplant Essential Data (TED) and the Comprehensive Report Form data (CRF). New centers are required to start at the TED level to ensure that they have sufficient staff and training to submit quality data in a timely manner before being invited to participate at the CRF level.
Data Collection Forms
- TED Forms: 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. When research consent was provided, these data may also be used in research studies.
- CRF Forms: Data are included in research studies. These forms collect more detailed data including disease assessments at each follow-up visit, expanded acute and chronic GVHD data, engraftment data, etc.
For each infusion type performed at the center, the medical director will be required to designate the reporting level (at the time of center member 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
- Do not perform infusion type
- Perform infusions, but do not report to CIBMTR (Only allowed for non-US centers)
- Allogeneic – Unrelated 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
- Do not perform infusion type
- NMDP-Facilitated Infusions – If center is receiving products from NMDP, those infusions must be reported to CIBMTR (Only allowed for non-US centers)
- Perform infusions, but do not report to CIBMTR (Only allowed for non-US centers)
- 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
- Cellular Therapy Infusions are selected for CRF or TED track based on the product infused
- Gene Therapy Infusions are always selected for CRF
Additional Details for HCT Reporting
TED Only
Center reports all infusions of this type to CIBMTR. Cases are assigned to TED follow-up track unless CRF is required for a study.
- Forms include 2814, 2807, 2400, 2402, 2004, 2005, 2006, 2450, plus select event-based forms (F2900 Recipient Death; F3500 Subsequent Neoplasms)
- 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
- Select forms are reimbursed after completion – (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 has 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 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 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.