Overview
The pre-study site assessment is a critical activity that directly influences trial success. A thorough evaluation of potential investigative sites before study initiation helps identify sites with the capability, experience, and commitment necessary to conduct high-quality research. This checklist provides a structured framework for evaluating sites across all essential dimensions, from regulatory compliance to operational readiness.
Completing this assessment before site selection reduces the risk of enrollment delays, protocol deviations, and data quality issues that can compromise trial integrity. Each section should be completed during site visits, teleconferences, or through document review, with findings documented for the site selection decision.
Site Identification and Contact Information
- Site name and address verified and documented
- Principal Investigator name and contact information confirmed
- Primary study coordinator identified with contact details
- Site institutional affiliation documented (if applicable)
- Time zone and preferred contact hours noted
- Backup contacts identified for PI and coordinator roles
Principal Investigator Qualifications
- Current curriculum vitae reviewed and on file
- Medical license verified as current and unrestricted
- Board certification status confirmed (if applicable)
- Relevant therapeutic area experience documented
- Prior clinical trial experience assessed (number and type of studies)
- GCP training certification reviewed and current
- Publication history in relevant therapeutic area reviewed
- No debarment or disqualification status confirmed via FDA and OIG databases
- Financial disclosure requirements discussed and understood
- Availability and time commitment for study duration confirmed
- Delegation of authority preferences discussed
Site Experience and Performance History
- Number of clinical trials conducted in past 3 years documented
- Experience with similar therapeutic areas assessed
- Experience with similar study designs evaluated
- Phase of development experience verified (Phase I, II, III, IV)
- Previous sponsor relationships and references obtained
- Enrollment performance history reviewed (targets met vs. actual)
- Screen failure rates from previous studies evaluated
- Protocol deviation history assessed
- Regulatory inspection history reviewed (FDA Form 483s, warning letters)
- Data quality metrics from previous studies evaluated
Regulatory and Ethics Compliance
- IRB/IEC affiliation identified and contact information obtained
- IRB/IEC approval timelines discussed and documented
- Local regulatory requirements identified and understood
- Site registration status verified (FWA number, FDA Form 1572 history)
- Institutional policies on clinical research reviewed
- Conflict of interest policies reviewed and compliant
- Standard operating procedures for research activities available
- Quality assurance program in place and documented
- Process for protocol amendments and safety reporting confirmed
- HIPAA/data privacy compliance procedures verified
Patient Population and Recruitment Capability
- Target patient population access assessed and quantified
- Database query conducted to estimate eligible patients
- Referral networks and community partnerships identified
- Competing studies that may impact enrollment identified
- Seasonal factors affecting patient availability considered
- Geographic catchment area evaluated
- Patient demographics compatible with protocol requirements
- Previous enrollment success with similar inclusion/exclusion criteria
- Recruitment strategies and outreach capabilities discussed
- Retention strategies and historical retention rates reviewed
- Patient advocacy group relationships identified
Facilities and Equipment
- Physical space adequate for study procedures and patient visits
- Private areas available for informed consent discussions
- Examination rooms appropriate for study assessments
- Emergency resuscitation equipment available and maintained
- Laboratory facilities on-site or contracted laboratory identified
- Required specialized equipment available (ECG, imaging, etc.)
- Equipment calibration and maintenance logs reviewed
- Sample processing and storage capabilities confirmed
- Centrifuge and refrigeration/freezer capacity adequate
- Temperature monitoring systems for sample storage in place
- Secure storage for investigational product verified
- Environmental controls for IP storage confirmed
- Pharmacy facilities adequate (if applicable)
- IT infrastructure adequate for EDC and electronic systems
Staffing and Resources
- Qualified sub-investigators identified and CVs obtained
- Study coordinator experience and qualifications assessed
- Research nurse availability confirmed
- Pharmacy support available (if applicable)
- Laboratory technician support available
- Administrative support identified
- Staff GCP training status verified
- Staff therapeutic area training assessed
- Protocol-specific training plan discussed
- Coverage plan for staff absences documented
- Staff turnover history evaluated
- Language capabilities adequate for patient population
Financial and Contractual Considerations
- Budget expectations discussed and preliminary agreement reached
- Payment terms and procedures clarified
- Institutional overhead requirements documented
- Contract approval process and timelines understood
- Legal/contracts department contacts identified
- Insurance and indemnification requirements clarified
- Grant or funding requirements identified (if academic site)
Follow-Up Actions
- All findings documented in site assessment report
- Site visit summary completed with recommendations
- Outstanding items identified with responsible parties and timelines
- Site selection decision criteria applied and documented
- Communication of selection decision to site planned
Assessment Summary
Use this section to document overall findings and recommendations:
Strengths Identified: Document key site strengths here
Areas of Concern: Document any concerns or risks identified
Recommendation: Document recommendation for site selection decision
Assessor: _________________ Date: _________________
