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AUDIT PLAN AND REPORT
AUDIT NUMBER: AUD-YYYY-EXT-001
AUDI T TI TL E
Transplant Essential Data Forms Data Accuracy Audit
DI VI S I O N
DI VI S I O N
CO NTACT
AUDI T
DAT E ( S )
RE S P O NS E S
RE Q UI RE D
BY
30 business days from the date submitted to Auditee 1
7 business days from the date submitted to Auditee (for Critical
Observations)
AUDI TO RS
SOPS
RE V I EW E D
AUDI T
O BJE CT I V E
To review the accuracy of information submitted to the CIBMTR data
registry via FormsNet”.
AUDI T
S CO P E
Selected clinical data points, both as mandated during FACT inspection and
randomly chosen by auditor, in the completed CIBMTR data collection
forms (from pre-transplant to 100 days) and related source documentation
for 10 allogeneic and 5 autologous transplants identified for upcoming FACT
inspection.
AUDI T
CRI T E RI A
FACT-JACIE International Standards for Cellular Therapy Product
Collection, Processing & Administration (current edition)
CIBMTR Data Management Manual
http://www.cib