CTEO TIP SHEET | Preparing for an AuditUpon receiving Notification of an Audit Confirm all appropriate study team members are notified about the audit including the researchpharmacy (if applicable) For an external Audit: Notify the Quality Assurance Office for Clinical Trials (QACT), Office forHuman Research Studies (OHRS), DFCI Research Pharmacy (and other participating institutionssresearch pharmacies), and Clinical Trials Offices for all external audits.research pharmacies), and Clinical Trials Offices for all external audits. Site study coordinators are responsible for reserving a space for the auditors at their location.Preparing for an Audit Review Regulatory Binder for completeness and accuracy Gather the requested information for each participant selected, this can include the following:Participant Entry and eligibility materials including informed consentPre-therapy, on-study, and follow-up requirement documentationTTrreeaattmmeenntt aaddmmiinniissttrraattiioonn aanndd ddoossee mmooddiiffiiccaattiioonnssToxicities and reporting of adverse eventsResponse assessmentsData Collection FormsDrug accountability Review information gathered for completeness and accuracy Review and update IRB correspondence Scan CRFs for empty data fieldsDDuurriinngg tthhee AAuuddiitt Give the auditor access to the requested records at the predefined time and place Be available for questions and help locate missing informationTIP SHEET Preparing for an ...
CTEO TIP SHEET | Preparing for an Audit
Upon receiving Notification of an Audit
Confirm all appropriate study team members are notified about the audit including the research
pharmacy (if applicable)
For an external Audit: Notify the Quality Assurance Office for Clinical Trials (QACT), Office for
Human Research Studies (OHRS), DFCI Research Pharmacy (and other participating institutionss
research pharmacies), and Clinical Trials Offices for all external audits.research pharmacies), and Clinical Trials Offices for all external audits.
Site study coordinators are responsible for reserving a space for the auditors at their location.
Preparing for an Audit
Review Regulatory Binder for completeness and accuracy
Gather the requested information for each participant selected, this can include the following:
Participant Entry and eligibility materials including informed consent
Pre-therapy, on-study, and follow-up requirement documentation
TTrreeaattmmeenntt aaddmmiinniissttrraattiioonn aanndd ddoossee mmooddiiffiiccaattiioonnss
Toxicities and reporting of adverse events
Response assessments
Data Collection Forms
Drug accountability
Review information gathered for completeness and accuracy
Review and update IRB correspondence
Scan CRFs for empty data fields
DDuurriinngg tthhee AAuuddiitt
Give the auditor access to the requested records at the predefined time and place
Be available for questions and help locate missing information
TIP SHEET Preparing for an Audit
Updated August 2009
1Helpful Hints
Refer to the “Eligibility”, “Subject Entry”, and “Required Data” sections in the protocol when
reviewing participant records for accuracy and completeness
Create a “note-to-file” when there is a discrepancy that requires clarification in the record. Signn
aanndd ddaattee aannyy ““nnoottee--ttoo--ffiillee””,, aanndd iinncclluuddee hhooww tthhee iinnffoorrmmaattiioonn wwaass oobbttaaiinneedd
Refer to CTEO Tip Sheet “FDA Audit Etiquette” for guidance on FDA audits
Common Errors
Problem Preventions
Lack of documentation in source documents about Ensure that the consent PROCESS is outliinneedd
consent process in each participant file and that it describeess
hhooww ccoonnsseenntt wwaass oobbttaaiinneedd
Participant not re-consented with updated informed If it has been determined that participanttss
consent form need to be re-consented, make sure that
you are using the most recent consent forrmm
to obtain consent and don’t forget to
document the re-consenting process in thedocument the re-consenting process in the
participant file
Missing dates or signatures of participant, parent, Review and verify the consent form containsains
or investigator all appropriate signatures and dates and
explain any missing information adequateellyy
in a note-to-file
Adverse events not reported to study teams Ensure that all adverse events are reporteedd
to the appropriate individuals including sttuuddyy
teams at other institutions (if you are the
lead site) and the overall PI (if you are thee
non-lead site)
AAddvveerrssee eevveennttss nnoott rreeccoorrddeedd oonn CCRRFFss EEnnssuurree tthhaatt AALLLL aaddvveerrssee eevveennttss aarree rreeppoorrtteedd
on the appropriate CRFs in the time framee
indicated in the protocol
Reasons for missed or delayed doses not Explanation must be recorded in source
documented documentation if the treatment, as outlineedd
in the protocol, was modified in any way..
This includes missed or delayed doses. TheThis includes missed or delayed doses. The
explanation should include why the dose was was
missed or delayed
Treatment administration details not documented The details of how the treatment was
administered must be in source
TIP SHEET Preparing for an Audit
Updated August 2009
2documentation and include (if appropriate)e)
dose, route of administration, length of
administration and any other pertinent
information
No documentation of treatment compliance for at Ensure that the protocol is using an IRB
home medication approved “Drug Diary” and educate
participants to fill out accurately and bringg iitt
with them to each study visit as well as annyy
remaining pills. Have participant sign andd
date each Drug Diary and keep in researchch
file as source documentation
Performance status not documented Have the Investigator use the QACT
Eligibility Check List to dictate an on-studyEligibility Check List to dictate an on-study
note. This will ensure all eligibility criteriaia
are appropriately documented including
Performance status
Procedures and/or labs completed outside of Develop a system that allows you to keepp
required time points track of date requirements for ALL study
pprroocceedduurreess aanndd eennssuurree tthheeyy aarree oobbttaaiinneedd aatt
the appropriate time points as dictated byy
the protocol.
TIP SHEET Preparing for an Audit
Updated August 2009
3