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 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.
  • ≥ 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.
  • > 3.0% and Milestone Reports are not required to be submitted as a result of the most recent CIBMTR Data Audit:
    • A summary report for the FACT-CIBMTR Data Audit Committee to evaluate that includes:
      1. Appendix D of the CIBMTR Audit Results Report
      2. Approved corrective action plan (CAP) submitted to CIBMTR
      3. Progress on implementation of the CAP
      4. An audit report on a recent internal audit using current data
    • The Clinical Inspector will receive recommendations from the Data Audit Committee and review these items with the program.
  • > 3.0% and Milestone Reports are required to be submitted as a result of the most recent CIBMTR Data Audit:
    • 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.
• Programs not audited by CIBMTR must submit a summary report to FACT every 6 months or an approved alternative.
• Programs not submitting data to CIBMTR are encouraged to submit data and are required to submit a summary report to FACT every 6 months or an approved alternative.
• Summary reports be submitted as singular document, using the FACT Data Management B9 Response Report Template. Summary reports must include:
  • Corrective actions the program previously implemented, related to data accuracy.
    Note: If this is the program's first internal data accuracy audit, corrective actions are not required.
  • Progress on implementation of the CAP
  • An audit report on a recent internal audit using current data
• Programs must provide updates at the time of annual reporting, compliance application, post-inspection, and as otherwise directed by the Data Audit Committee