Use the First Two Pages of This Checklist to Record Information Provided by the Inspectors

INSTRUCTIONS:

Use the first two pages of this checklist to record information provided by the inspectors at the time of initial contact. The remainder of the document should be used to track the progress of the pre-inspection preparation tasks. Check each item as it is completed and record pertinent comments.

Initial Inspection Notification
Notification Date: / Visit Start Date:
Estimated Time of Arrival: / Expected Duration:
Inspectors Contact Information: / Name:
Telephone:
Title:
Additional Inspectors’ Names:
Protocol Information
Protocol Number(s): / Details:
Principal Investigator:
Co-Investigator(s):
Reason for inspection
Routine / Details:
Directed (e.g., for cause)
Follow-up (e.g., 483; warning letters)
Other: / Details:
Personnel Requested by Inspector Use a separate sheet if needed.
Who: / When:
Documents Requested by Inspector Use a separate sheet if needed.
Document requested
(Check box if document requested prior to inspection) / Document requested
(Check box if document requested prior to inspection)
Shipping / Delivery information for documents requested prior to the inspection visit
Name of Recipient: / Delivery Date:
Address: / Overnight
Registered
Certified
Email: / Courier:
Delivery Details:
Please document any other details from the initial contact not noted above:
Administrative
Task / Yes
(Done/ Available) / No
(Provide comment) / Comments
Notify all parties of impending inspection / Sponsor
IRB/EC
Quality Improvement Program
Principal Investigator
Sub-Investigator(s)
Study Coordinator(s)
Pharmacy (if applicable)
Laboratory(ies)
Medical Records
Legal Counsel
Other (specify in comments)
Review Internal SOPs / IRB Policies, Department SOPs, Research Protocol
Identify work space for the Inspector / Conference room/office
Telephone
Copier
Review staff schedules / Review staff schedules to ensure staff availability (vacations, appointments, miscellaneous time off, etc.)
Reschedule non-essential visits/meetings if possible
Regulatory Documents
Task / Yes
(Done/ Available) / No
(Provide comment) / Comments
Locate, compile, organize, and review documents for accuracy and completeness / Note: Use QIP’s Investigator Self-Assessment checklist as a guide for conducting internal review of study regulatory files
Notes:
Labs and External Clinical Sites
Task / Yes
(Done/ Available) / No
(Provide comment) / Comments
Locate, compile, organize, and review documents for accuracy and completeness / Investigational agent accountability logs and are on file, complete and accurate
Specimen logs are on file, complete and accurate
Ordering/shipping receipts on file
Copies of laboratory audits, action plans, and corrective action reports
Temperature logs for applicable equipment (refrigerators, freezers, storage cabinets, etc.)
Calibration and maintenance records for all laboratory equipment (if applicable)
Other (please add any additional site-specific pharmacy documents below)
Notes: