Data Management Resource Center

CIBMTR Resources

CIBMTR has many Training and Reference materials, including the following:

• Use these reference manuals to learn how to submit data to CIBMTR:
  CIBMTR Manuals
• Use these educational training modules to focus on a particular area:
  Online Training
• Materials and presentations from data management conferences:
  Clinical Research Professionals / Data Management
• 2020 Data Managers Meeting Presentation:
  Rebuilding a Data Management Team to Improve Program Efficiency and Clinical Compliance
• Accessing Critical Field Spreadsheets
• Disease Trackers are available on the CIBMTR Portal in the Audit Tab.
  If you do not have access, submit a ticket through CIBMTR Center Support.

Educational Resources

• FACT Data Audit Policy
• FACT Data Management: Closing the Data Audit Process Through Follow-Up
• Announcing the FACT-CIBMTR Collaborative Data Audit Process
• How FACT Accredited Clinical Programs Continue to Raise the Bar in Quality
• FACT QM Series Module 9: Audits
• FACT QM Series Module 11: Corrective Action Plans
• FACT Inspection and Accreditation Workshops and Quality Boot Camps

Examples

Training Document Examples

• Training Manual and Competency Checklist Example 1

Program Audit Reports

• Annual Review of Audits
• Audit Report Template 1
• Audit Report Template 2
• Audit Report Example 1
• Audit Report Example 2

Guidelines for Data Management Submissions

• Programs that are audited by CIBMTR follow these submission guidelines based on the most recent CIBMTR Data Audit Results Report. If the critical field error rate (CER) is:
  • ≤ 2.0%:
    • Additional information is not required.
    • The Clinical Inspector will review the program's overall data management process, internal data accuracy audit reports, and assess for commendable practices and compliance with the standards. 
  • > 2.0% and ≤ 3.0%:
    • A satisfactory internal data accuracy audit report.
    • The Clinical Inspector will review the program's submission with suggestions from the Data Audit Committee or FACT staff and assess compliance with the standards.
  • If Milestone Reports are required to be submitted to CIBMTR, regardless of CER:
    • The Milestone Report will be reviewed by the Data Audit Committee in collaboration with CIBMTR. A joint response will be sent to the program.
    • The Clinical Inspector will receive recommendations from the Data Audit Committee and review these items with the program during the inspection
    • If your program has completed the Milestone Report requirements, depending on the program's CER and the Data Audit Committee's decision, FACT submissions may be required.
  • > 3.0% and Milestone Reports are not required:
    • Progress on implementation of the CAP submitted to CIBMTR in response to the failing CIBMTR data audit.
    • An audit report from a recent internal data accuracy audit assessing current data.
    • The Clinical Inspector will receive recommendations from the Data Audit Committee and review these items with the program during the inspection.
• Programs must submit data specified in B9.1 for allogeneic and autologous transplants to a national or international database. [B9.1.1]
  • The Data Audit Committee recommends programs submit data to CIBMTR.
  • If an external data audit is not available from the national or international database the program is submitting to, FACT requires the program submit corrective actions, progress on corrective actions, and an internal data accuracy audit report to FACT every six months or an approved alternative as determined by the Data Audit Committee.
• Programs must provide updates at the time of the Annual Report, Compliance Application (pre-inspection), post-inspection, and as otherwise directed by the Data Audit Committee.