FDA SITE INSPECTION PREPARATION CHECKLIST

Task
Audit Notification

Organization

Items
Done NA Notes
Sponsor
Administration
IRB
Notify all parties of
Principal investigator
impending audit
Pharmacy
Laborator(ies)
Legal counsel
Work space
phone
Reserve audit space
copier
table
Prepare general overview
of study
Study overview
List personnel and
delegated responsibilities
List all subjects including
name, contact info.,
enrollment and completion
dates, and MRN#
Subject lists

List all subjects screened

with enrollment or reason
not enrolled
File Management
Protocol (all versions)
Investigators' Brochure (all
versions)
Organize files by
Protocol amendments
heading and arrange
Form FDA 1572 (all
in chronological order
versions)
CVs (PI, others listed on
1572)
Initial IRB approval letter
Initial IRB approved
informed consent
Amendment approval
letters
Approved amended
informed consents
Signed original consent
forms for enrolled subjects
IRB files
stapled to human subjects
bill of rights

Communication

Laboratory

Signed original consent

forms for screened
subjects
Adverse experience
submissions to IRB
IRB continuing reviews
Sponsor correspondence
CRO correspondence
Monitoring Log
Laboratory certification(s)
Laboratory normal ranges
CV of laboratory director
Records of drug reciept

Records of drug dispensing

Drug accountability

Adverse Events

Subject documents

Data Review

Collect and review

data for all enrolled
subjects

Medical records
and/or study files
documenting data

Records of drug disposition

or return
Serious adverse event
reports made to sponsor
Serious adverse event
reports received from
sponsor
Completed CRFs for each
subject
Source documents/medical
record for each subject
CRFs
Data correction forms for
CRFs (where applicable)
Condition of all subjects
enrolled at time of entry
showing eligible
All exposure to test article
Concomitant medications
Clinical assessments of
subject during study
Laboratory reports
Diagnostic test reports
Diagnostic test films (if
applicable)
Dose modifications
Adverse events
Protocol exceptions
Early withdrawals