Regulatory Inspection Preparation

Inspection Plan Checklist

  • Identify key study personnel and their study related activities
  • Verify that adequate supervision of the medical care by the Principal Investigator has been provided
  • Review all correspondence with the REB to ensure that all approvals are in place
  • Ensure the procedure for obtaining informed consent are consistent with Regulatory Authority and REB specifications
  • Verify the ICF document has been the correct and REB approved version and was signed and dated prior to any study related procedures
  • Ensure that the protocol has been adhered to and that it was approved by the regulatory agency(ies) and local REB
  • Verify all data has been transcribed/entered accurately into Case Report Forms from source documents
  • Review documentation of Adverse Events to ensure reporting requirements have been met
  • Drug accountability and reconciliation is current and correct
  • Verify that drug is manufactured, handled and stored according to GMP, protocol and labelling requirements
  • Confirm that investigational product is labeled in accordance to regulations
  • Test samples have been handled according to protocol and records of shipping of all test articles are in order
  • Review sponsor monitoring reports or correspondence
  • Confirm provisions for record retention

Document Checklist for Inspections

  • Study Protocol and any amendments
  • Copy of all approved ICFs and any updates to the ICF document
  • QIU
  • REBA (or other acceptable attestation)
  • Signature and Delegation Log
  • Organization Chart for Centre or Group
  • Personnel CVs
  • Investigator Brochure or Product Monograph
  • Training records
  • SOPs
  • Correspondence between:
    • Sponsor and Regulatory Agency
    • Sponsor and Site
    • Site and Research Ethics Board
    • Site personnel correspondence applicable to study 
  • Adverse Event and SAE documentation
  • Drug Accountability Records
  • Service Providers’ Contracts
  • Equipment Calibration, Maintenance and Temperature Records
  • Source Data
  • Case Report Forms
  • Subject Enrollment Log

Timelines and Preparation Schedule

  • Inquire whether or not Regulatory Agency can give you an indication of what their focus will be
  • Map out timeline – Gant Chart
  • Be realistic and stick to schedule/targets
  • Ask for Assistance from Sponsor/Monitor
  • Involve Entire Study Team in Preparations

Do's and Don't's

  • Do view the experience as a learning opportunity
  • Do accept help in preparation
  • Do not try to make everything look perfect
  • Do not write excessive Note-to-Files
  • Do not panic!