FDA Bioresearch Monitoring (BIMO) Inspection Checklist Form
Use this form to document and track your site's FDA BIMO inspection readiness and results. Complete all checklist items and record findings and corrective actions as needed.
Inspection Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Inspector Name
*
First Name
Last Name
Site Name / Location
*
Inspection Scope / Area
*
Please Select
Clinical Investigations
Nonclinical Laboratories
Sponsor/Monitor/CRO
IRB/IEC
Other
Applicable Records Reviewed
*
Protocol and Amendments
Informed Consent Forms
Case Report Forms
Source Documents
Drug Accountability Records
Other
Checklist: BIMO Inspection Readiness
*
All required records available
Staff trained and present
Facilities accessible
Equipment calibrated
Safety protocols in place
Other
Inspection Findings
*
Corrective Actions (if any)
Inspection Completed and All Information Accurate?
*
Yes
No
Inspector Sign-Off (Type Full Name)
*
Submit Inspection
Should be Empty: