Clinical Trial Site Monitoring Visit Checklist [FREE PDF]
Clinical research associates (CRAs) use this checklist for site monitoring visits per FDA 21 CFR 312 IND requirements and ICH GCP E6(R2) good clinical practice guidelines.
- Industry: Pharmaceutical / Clinical Research
- Frequency: Per Visit
- Estimated Time: 25-30 minutes
- Role: Clinical Research Associate
- Total Items: 8
- Compliance: FDA 21 CFR 312, ICH GCP E6(R2)
Source Data Verification & CRFs
Verify source data against case report forms.
- Has source data verification been completed for required data points per the plan?
- Have outstanding data queries been reviewed and resolved with site staff?
- Are all active subject informed consents signed with the current IRB-approved version?
- Source verification notes
Investigational Product & Regulatory
Verify IP accountability and regulatory file completeness.
- Is IP accountability log current with dispensing matching subject records?
- Is IP stored per protocol requirements with temperature logs reviewed?
- Is the Investigator Site File (ISF/regulatory binder) complete and up to date?
- IP and regulatory notes
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Why Use This Clinical Trial Site Monitoring Visit Checklist [FREE PDF]?
This clinical trial site monitoring visit checklist [free pdf] helps pharmaceutical / clinical research teams maintain compliance and operational excellence. Designed for clinical research associate professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: per visit.
Ensures compliance with FDA 21 CFR 312, ICH GCP E6(R2). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Clinical Trial Site Monitoring Visit Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Source Data Verification & CRFs, Investigational Product & Regulatory. It is designed for pharmaceutical / clinical research operations and compliance.
How often should this checklist be completed?
This checklist should be completed per visit. Each completion takes approximately 25-30 minutes.
Who should use this Clinical Trial Site Monitoring Visit Checklist [FREE PDF]?
This checklist is designed for Clinical Research Associate professionals in the pharmaceutical / 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.