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CIBMTR Audit Program

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CIBMTR Audit Program

Audit Purpose

Ongoing data audits are performed at all Center for International Blood and Marrow Transplant Research (CIBMTR) participating Transplant Centers (TC) as part of the CIBMTR’s overall data quality assurance program. The audit compares data in source documents maintained at the Transplant Center with data contained in the CIBMTR outcomes registry. The audits identify errors that otherwise would go undetected by the online validations built into the data entry program.

 

Audit 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 the data reported to the CIBMTR
  • Identifying systemic and non-systemic errors
  • Requesting corrective action for errors identified during the audit
  • Providing training to transplant centers data management staff

The Stem Cell Therapeutic Outcome Database (SCTOD)

The CIBMTR was awarded a contract from HRSA (Health Resources and Services Administration) to create and manage the SCTOD which is a national registry for allogeneic transplant information. It is a component of the C.W. Bill Young Cell Transplantation Program (the Program), which was established by the Stem Cell Therapeutic and Research Act of 2005 and reauthorized by the Stem Cell Therapeutic and Research Reauthorization Act of 2010. The SCTOD requires collection and receipt of outcomes data for all recipients of allogeneic (related and unrelated) transplants from transplant centers and other appropriate parties. This includes procedures performed in the US and procedures outside the US that involve products from the US.

 

CIBMTR Data Quality Program - The Data Quality Audits

As part of the CIBMTR on-going data quality program, on-site data quality visits are conducted at regular intervals to ensure the accuracy of data submitted to CIBMTR’s observational database. CIBMTR Clinical Research Associates (CRAs, also referred to as “auditors”) visit transplant centers qualifying for audit to compare submitted data with source documentation. All data elements on all forms are subject to audit. However, the audit concentrates on “critical” data, i.e., data most likely to be included in a research study. Data elements considered “non-critical” are randomly audited to increase the validity of the audit error rates. Consent forms are also reviewed for completeness. 

Following the audit, a report will be generated and corrective action may be required. The final report will also contain the center’s critical, random, and overall field error rates. Transplant center audit preparation is key to ensuring the logistical success of the audit.

 

Audit Cycles

Each transplant center is audited 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.
  • For cause audits may be scheduled based on error rates.

 

FACT / CIBMTR Collaboration

Beginning in 2017, FACT and CIBMTR have 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 will no longer perform a data audit at the on-site FACT inspection. This will eliminate the need for data sheets to be prepped only for FACT inspectors, and allow the clinical inspector to focus on adequacy of corrective actions and quality improvement.
  • All verification of the accuracy of data against source data will be done by the CIBMTR audit teams on site according to their current practices and schedules. The current CIBMTR process will not change.
  • The FACT-CIBMTR Data Audit Committee will review CIBMTR audit reports and corrective action plans to assess compliance with Standards, implementation of effective corrective action, and improvements.
  • Timeliness and completeness of data submission will also be assessed by the Committee using CPI reports from CIBMTR indication "in good standing".

 For more information, including a list of frequently asked questions, see the FACT CIBMTR Audit Collaboration Letter.pdf.

 

 

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Last Updated: 8/28/2017 1:51 PM
CIBMTR