The center will be provided with a record of all data changes made via the Data Change Summary, included with the final Audit Report. The Data Change Summary should be reviewed by the center, signed by the medical director acknowledging the changes made to the database as part of the audit, and returned to the lead auditor. The auditors will make all data corrections to the database, and the audited forms will remain locked after the audit. Following the audit, if the transplant center wishes to make additional changes, an ECF and supporting documentation can be submitted to CIBMTR Center Support for review.
Last modified: Sep 15, 2022
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