Center Status Overview
The Stem Cell Therapeutic Outcomes Database (SCTOD) is part of the C.W. Bill Young Cell Transplantation Program, authorized by the Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129) and reauthorized by the Stem Cell Therapeutic and Research Reauthorization Act of 2010 (Public Law 111-264), and the Stem Cell Therapeutic and Research Reauthorization Act of 2015 (Public Law 114-104).
As the contract holder, CIBMTR is required to collect data for all allogeneic (related and unrelated) hematopoietic cell transplants (HCTs) performed in the United States, and for all HCTs utilizing products procured through the program, but performed outside of the United States.
CIBMTR has established processes to assess and close any gaps that exist in data reporting to the SCTOD. To determine a member center’s participation level, CIBMTR has established center status level assignments. These statuses determine if a center is required to comply with the CIBMTR Continuous Process Improvement (CPI) program.
Center Status Level Assignments
Pending Status
A center that has submitted a request to become a CIBMTR center but has not yet completed all of the requirements for activation is considered pending. In order to be activated as a participating CIBMTR center, the center must complete regulatory documentation including:
- Master Healthcare Data (MHA)
- Sample Submission Agreement
- IRB approval documents for the relevant consent forms
For additional information, please visit the Regulatory Documentation Standards section of the Data Management Guide.
Active – Developing Status
A center that has submitted all regulatory documentation, committed to a reporting status, and has staffing (at least one primary Data Manager and one Medical Director) is considered a developing CIBMTR center. Staff at developing centers are not eligible for CIBMTR leadership roles. These centers are either new CIBMTR centers or have been in CPI suspension for 3 consecutive trimesters (a year). These centers only submit TED-level data and are not held to CPI or Audit standards yet, but will receive a Research Readiness Report to track their reporting metrics and key performance indicators (KPIs). For additional information, visit the Research Readiness Report section of the Data Management Guide. These centers are reviewed on a trimester basis to determine if they met the milestones to be promoted to an established center.
Milestones to becoming an Established center
- US allogeneic center
- One trimester meeting reduced CPI targets (refer to table below)
- Consent rate greater than 75% (refer to Table 5 in Research Readiness Report)
- All other centers
- Two consecutive trimesters meeting reduced CPI targets (refer to table below)
- Consent rate greater than 75% (refer to Table 5 in Research Readiness Report)
Threshold CPI Target Metrics
| Requirements | Threshold Target |
|---|---|
| Complete Critical Forms On Time | ≥ 35% Completed by due date |
| Complete Critical Forms Due During the Previous Trimester | ≥ 80% Complete by end of trimester |
| Complete Study Supplemental Forms Due During the Previous Trimester | ≥ 90% Complete by end of trimester |
| Complete All Other Forms Due During the Previous Trimester | ≥ 80% Complete by end of trimester |
| Resolve Queries Placed During the Previous Trimester | ≥ 80% Complete by end of trimester |
Active – Established Status
A center that has registered new patients and submitted forms during the most recent 24-month period to CIBMTR is considered established. Established centers are subject to all CPI and audit requirements. Centers can submit either TED-level or CRF-level data (subject to review). Staff from established centers are eligible to participate in CIBMTR leadership roles. For centers unable to meet CPI requirements for 3 consecutive trimesters (a year), centers will be demoted to a developing status.
Active – Follow-Up Status
A center that has submitted forms during the most recent 24-month period but has not registered any new patients during that same time is considered to be in follow-up status. Follow-up centers are subject to form and query requirements of the CPI program but are exempt from CTA tasks.
Inactive Status
A center that has not submitted forms or registered new patients within the last 24-month period is considered inactive. Inactive centers are not subject to any CPI requirements. An Inactive status prohibits center staff from participating in CIBMTR leadership roles. In this status, users at the center no longer have access to view or edit data reported to CIBMTR.
Closed Status
A center that has closed and prohibits center staff from participating in CIBMTR leadership roles.
| Date | Topic | Add/Remove/Modify | Description |
|---|---|---|---|
| 3/26/25 | Center Participation | Modify | Updated “Active” center status tiers and qualifications |
| 10/31/25 | Center Participation | Modify | Updated center status tiers and qualifications |
| 10/31/25 | Determining Reporting Levels | Add | New section created as US vs international center reporting levels were removed |
| 10/31/25 | Research Readiness Report | Add | New section created to describe components of report |