Audit – What to Expect ..........
Prior to the audit, 16 transplants are randomly selected from transplants done at the center being
audited, within the previous four years. Transplants are eligible for audit if the pre-transplant form (the
F2400 and/or F2000) and a 100 day post-transplant form (F2100 or F2450) are completed. All forms
associated with the transplant are audited.
Fields that are deemed crucial to outcomes based research, termed critical fields, are audited for each
transplant. Examples of critical fields include the product type, diagnosis date, transplant date,
Karnofsky/Lansky performance scores, preparative regimen therapies, acute/chronic GVHD, ANC
recovery, etc. Additional fields are randomly selected for audit, termed random fields, to ensure the
validity and reliability of the audit results. During the audit, source documentation within the medical
records is compared to the data submitted to the observational database for accuracy and errors are
assigned for any inconsistencies. In addition to reviewing critical and random data fields, auditors also
review the CIBMTR/NMDP Research Database and Research Sample Repository consent form(s) to
ensure that proper and full informed consent was given to participate in the database and repository, if
applicable.
A Corrective Action Plan is required if a center has a critical field error rate above 3% to address
reporting issues found during the audit. Additional issues requiring corrective action include systemic
errors in a reporting area, even if the critical field error rate is less than three percent (e.g., the date of
diagnosis was wrong on the majority of audited transplants) and any issues found on database or
repository sample consent forms.
When preparing for your CIBMTR data audit, please consider the following timeframes:
TIMEPOINT
8-10 weeks prior to audit
Data Management Staff Actions
 Return Pre-audit questionnaire (logistical details regarding
audit and layout of medical records)
 Request recipient medical records (inpatient, outpatient, stem
cell lab, laboratory, etc)
 Request access to Electronic Medical Records (EMR)
 Arrange a workspace for audit team
1-2 weeks prior to audit
 If EMR access given, ensure that proper access has been
granted (i.e., that the auditor would be able to log-in and audit
upon arrival)
 Determine that all paper records have arrived and are
complete
During the audit, a data manager may expect the following:
TIMEPOINT
Data Management Staff Actions
 Be available during the pre-specified time and place to
Day 1 of Audit
welcome auditor(s) to center
 Participate in initial audit opening meeting
 Describe the layout of the records, ensure proper EMR access
General auditing time
 Check on auditor(s) every few hours
 Be available to answer questions
 Triage “medical” questions to clinical staff
 Provide troubleshooting help for medical records or EMR
navigation
Last day of Audit
 Utilize audit as a training opportunity and ask questions to
auditors
 Complete any outstanding data requests
 Participate in closing meeting
Finally, following the audit, a data manager may expect:
TIMEPOINT
Data Management Staff Actions
 Receive missing documentation checklist, retrieve missing
One week following the audit
source documentation and submit for auditor review.
6 – 8 weeks following the
audit
 Receive the audit report and Corrective Action Plan Checklist
(if applicable)
4 weeks following the audit
report
 Submit a written plan to address each item on the Corrective
Action Plan Checklist, collaborating with data management
staff colleagues and medical director in a timely manner
Audit Team:
Deb Christianson, Senior Manager, Auditing and Monitoring dchristi@nmdp.org
Ashley Birch, Senior Clinical Research Associate abirch@nmdp.org
Edna Eich, Assistant Clinical Research Associate eeich@nmdp.org
Kari Gunderson, Clinical Research Associate kgunders@nmdp.org
Katie Newcomb, Clinical Research Associate cnewcomb@nmdp.org
Lauren Wendland, Senior Clinical Research Associate Lwendlan@nmdp.org
Matthew Petcoff, Senior Clinical Research Associate mpetcoff@nmdp.org
Wendy Elasky, Clinical Research Associate welasky@nmdp.org
Will Affield, Clinical Research Associate waffield@nmdp.org