Skip to Content
 
Center for International Blood and Marrow Transplant Research

Audit Program

Main Content

Purpose

The CIBMTR audit program evaluates the accuracy and completeness of data submitted to the CIBMTR observational database by comparing reported data with source documentation maintained at participating centers. Through independent review of submitted data, the program identifies reporting discrepancies, documentation gaps, and opportunities to strengthen data collection and reporting practices.

Impact of CIBMTR Audits

CIBMTR audits provide centers with an opportunity to assess the effectiveness of their data management, quality assurance, and reporting processes while identifying opportunities to strengthen overall data quality.

By identifying both isolated and systemic reporting issues, audits support continuous improvement and help centers improve the accuracy, consistency, and reliability of data submitted to CIBMTR. Audits also serve as a valuable educational resource by providing feedback, guidance, and training that promote the consistent application of CIBMTR reporting requirements and best practices.

Goals

The overall goal of the ongoing audits is to ensure the quality and accuracy of the research database by:

  • Ensuring the accuracy (and completeness) of data reported to CIBMTR
  • Identifying systemic and non-systemic reporting errors
  • Promoting consistent interpretation and application of CIBMTR reporting requirements
  • Providing education, feedback, and guidance to data management staff at CIBMTR participating centers
  • Requesting corrective action for errors identified during the audit

CIBMTR Data Quality Audits

As part of the on-going data quality program, CIBMTR conducts routine data quality audits at regular intervals to ensure the accuracy and completeness of data submitted to CIBMTR’s observational research database. CIBMTR Clinical Research Auditors, who compare submitted data against source documentation, provide education and guidance to data management staff, and identify systemic reporting issues at transplant centers selected for audit.

Although all data elements are subject to review, audits primarily focus on critical data fields, which are those most likely to be utilized in research and outcomes analyses. A sample of non-critical data fields is also audited to support the validity of reported error rates. In addition, consent documentation is reviewed for completeness and compliance.

Following the audit, CIBMTR issues a final audit report summarizing the findings, including the center's critical, random, and overall field error rates. Depending on the results, corrective actions may be required to address identified deficiencies and support continuous quality improvement. Thorough audit preparation remains essential to ensuring an efficient audit process and optimal outcomes.

Audit Cycles

Each center is audited at least once in a four-year cycle.

  • For centers previously audited, only recipients transplanted since the last audit date are eligible.
  • For new transplant centers, all recipients transplanted are eligible for audit.
  • Interim audits may be required for centers on audit consequences to assess progress toward corrective actions and improvements in reporting accuracy.

FACT / CIBMTR Collaboration

In 2017, FACT and CIBMTR launched a collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. The essential elements of the collaboration are:

  • FACT clinical inspectors no longer perform a data audit during the on-site FACT inspection. Centers do not need to prep data sheets for FACT inspectors. FACT inspectors focus on the adequacy of corrective actions and quality improvement.
  • CIBMTR audit teams verify the accuracy of submitted data against source data according to their practices and schedules.
  • The FACT-CIBMTR Data Audit Committee reviews CIBMTR audit reports and corrective action plans to assess compliance with standards, implementation of effective corrective action, and improvements.
  • The FACT-CIBMTR Data Audit Committee also assesses the timeliness and completeness of data submission using CPI reports from CIBMTR indicating "in good standing".

For more information, including a list of frequently asked questions, see the FACT CIBMTR Audit Collaboration Letter and the FACT Data Management Resource Center.

 

For detailed information regarding audit preparation, the audit process, audit results, corrective action requirements, frequently asked questions, and audit contact information, please refer to the CIBMTR Audit Guide.