Data Management
Resource Center 

CIBMTR Resources

CIBMTR has many training and reference materials, including the following:

• CIBMTR Manuals: Reference manuals on how to submit data to CIBMTR

• Online Training: Use these training modules to focus on a particular area

• Clinical Research Professionals/Data Management: Materials and presentations from data management conferences

• Rebuilding a Data Management Team to Improve Program Efficiency and Clinical Compliance: 2020 Data Managers Meeting Presentation

• Critical Field Spreadsheets: Instructions on how to access these spreadsheets

• Disease Trackers available on the CIBMTR Portal in the Audit Tab. If you do not have access, submit a ticket through CIBMTR Center Support

Educational Resources

Learn more about data audits and management as a part of corrective action plans.

• 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

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 6 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.

• PHI must be redacted prior to submission to FACT

Example Audits and Templates

See example audit reports and templates to help guide you as you put together your own.

• Annual Review of Audits

• Audit Report Template 1

• Audit Report Template 2

• Audit Report Example 1

• Audit Report Example 2

• Training Manual and Competency Checklist Example