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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.
The overall goal of the ongoing audits is to ensure the quality and accuracy of the research database by:
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.
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. See the Before the Audit section in the Audit Guide for more details and strategies for a successful audit.
Additional information about the CIBMTR audit visit can be found in the During the Audit section of the Audit Guide.
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. More details can be found in the After the Audit section of the Audit Guide.
Each transplant center is audited once in a four year cycle.
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:
For more information, including a list of frequently asked questions, see the FACT CIBMTR Audit Collaboration Letter.pdf.
For more detailed information about the audit process, a list of General FAQs, and audit contact information, please see the Audit Guide.
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