FDA Bioresearch Monitoring (BIMO) Inspection Checklist
FDA Bioresearch Monitoring (BIMO) Inspection Checklist
General Items
- Stay updated on FDA guidelines and regulations
- Conduct mock inspections to prepare staff
- Collect feedback from staff after the inspection
Pre-Inspection Preparation
- Gather necessary documents (protocols, consent forms, etc.)
- Review previous inspection reports
- Ensure all staff are informed and available
- Confirm the inspection date and time with the FDA
- Prepare a dedicated space for the inspectors
Documentation Review
- Verify study protocols are followed
- Check informed consent forms for compliance
- Ensure subject records are complete and accurate
- Review case report forms (CRFs) for consistency
- Confirm regulatory submissions are complete and current
Site and Facilities Inspection
- Inspect storage conditions for investigational products
- Check equipment calibration and maintenance records
- Ensure proper handling of biological samples
- Verify access controls to study areas
- Assess cleanliness and organization of the facility
Staff Training and Qualifications
- Confirm staff qualifications and training records
- Review training on Good Clinical Practice (GCP) guidelines
- Ensure staff understand their roles in the study
- Check for ongoing training programs and updates
- Assess communication procedures among staff
Subject Safety and Rights
- Review adverse event reporting procedures
- Ensure subjects' rights are protected
- Check for appropriate compensation and care for subjects
- Verify monitoring of subject compliance
- Confirm that subjects can withdraw from the study at any time
Post-Inspection Actions
- Document findings and observations from the inspection
- Prepare a response plan for any issues raised
- Schedule follow-up meetings with staff to discuss findings
- Implement corrective actions as needed
- Maintain open communication with the FDA post-inspection
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