Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee will assess the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.

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

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 Inspection and Accreditation Workshops and Quality Boot Camps

Guidelines for Data Management Submissions

Include the following in a report for the FACT-CIBMTR Data Audit Committee to evaluate:

  • Most recent CIBMTR Audit Results report, including Appendix D
  • The Corrective Action Plan (CAP) submitted to CIBMTR
  • Progress on implementation of the CAP
  • An audit report on a recent internal audit using current data
  • CPI letters from the past three trimesters
  • Programs not audited by CIBMTR must submit CAP related to past B9 citations, implementation progress of the CAP, and a recent audit report
  • Programs must provide updates at the time of annual reporting, renewal reporting, compliance application, and as otherwise directed by the committee
    • *PHI must be redacted prior to submission to FACT

    Examples

    FACT Data Management, B9: Response Report Template

    Training Document Examples

     

    Submission Examples

    Program Audit Reports


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