Clinical Trial Site Initiation Visit Checklist [FREE PDF]
This clinical trial site initiation visit checklist ensures compliance with ICH E6(R2) Good Clinical Practice requirements. Clinical Research Associate / Monitors use this checklist to verify regulatory compliance, document findings, and maintain safety and quality standards.
- Industry: Clinical Research
- Frequency: Per Site Initiation
- Estimated Time: 4-8 hours
- Role: Clinical Research Associate / Monitor
- Total Items: 21
- Compliance: ICH E6(R2) Good Clinical Practice, FDA 21 CFR 312 IND Regulations, EU Clinical Trial Regulation 536/2014, ISO 14155 Clinical Investigations Medical Devices
Documentation and Regulatory Review
Verify required documentation is current and complete.
- Standard Operating Procedures (SOPs) current and accessible?
- All personnel training records current for this activity?
- Required permits, licenses, and registrations current?
- Previous inspection findings reviewed and corrective actions verified?
Safety and Equipment Requirements
Verify safety equipment, PPE, and emergency preparations.
- Required PPE available, clean, and in good condition?
- Emergency equipment (eyewash, shower, extinguisher) accessible?
- Safety Data Sheets (SDS) available for all hazardous materials?
- Emergency contact and response procedures posted?
Operational Compliance Checks
Verify operations comply with regulatory requirements.
- Approved procedures being followed without deviation?
- Equipment qualified/calibrated and within calibration period?
- Environmental monitoring (temp, humidity, pressure) within spec?
- All materials, products, and containers properly labeled?
- Data recorded contemporaneously with no unexplained alterations?
Waste Disposal and Environmental Compliance
Verify proper waste handling and disposal.
- All waste properly labeled with contents and hazard class?
- Waste containers appropriate for waste type and in good condition?
- Waste streams segregated per regulatory requirements?
- Waste disposal records maintained?
Findings and CAPA
Document findings and corrective/preventive actions.
- Any deviations or non-conformances identified?
- CAPA initiated for any findings?
- Photo documentation of findings?
- Inspection findings and recommendations
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Why Use This Clinical Trial Site Initiation Visit Checklist [FREE PDF]?
This clinical trial site initiation visit checklist [free pdf] helps clinical research teams maintain compliance and operational excellence. Designed for clinical research associate / monitor professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: per site initiation.
Ensures compliance with ICH E6(R2) Good Clinical Practice, FDA 21 CFR 312 IND Regulations, EU Clinical Trial Regulation 536/2014, ISO 14155 Clinical Investigations Medical Devices. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Clinical Trial Site Initiation Visit Checklist [FREE PDF] cover?
This checklist covers 21 inspection items across 5 sections: Documentation and Regulatory Review, Safety and Equipment Requirements, Operational Compliance Checks, Waste Disposal and Environmental Compliance, Findings and CAPA. It is designed for clinical research operations and compliance.
How often should this checklist be completed?
This checklist should be completed per site initiation. Each completion takes approximately 4-8 hours.
Who should use this Clinical Trial Site Initiation Visit Checklist [FREE PDF]?
This checklist is designed for Clinical Research Associate / Monitor professionals in the clinical research industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.