28 January, 2026
Author : Dr Vijaykumar Gawali

Topic : SITE QUALIFICATION VISIT (SQV)

1 Definition

A Site Qualification Visit (SQV)—also called a Pre-Study Visit (PSV)—is conducted by the sponsor or CRO to evaluate whether the site is suitable for participation in a clinical trial. The SQV determines site selection and must demonstrate that the site has the required infrastructure, staff capability, patient pool, and compliance systems.

2 Purpose of SQV

• Assess site’s ability to conduct the study
• Verify investigator interest & availability
• Evaluate patient recruitment potential
• Examine equipment, facilities, pharmacy, lab capabilities
• Ensure site can comply with protocol, SOPs & GCP
• Confirm staff qualification and experience

3 Responsibilities of the CRC for SQV Preparation

A. Facility Readiness

The CRC ensures that the sponsor sees a well-organized, compliant environment:

• Private room for consenting
• Dedicated source documentation space
• Archival area (secure, controlled access)
• Sample collection & processing area
• Calibrated centrifuge, refrigerator, freezers
• IP storage room with temperature monitoring
• Emergency equipment availability (as per therapeutic area)

Documentation to display:

• Calibration certificates (current)
• Temperature logs
• Lab certifications (NABL/CAP)
• SOP binders

B. Staff Qualification & Capability

CRC prepares:

• PI & Sub-PI CVs (updated, signed)
• GCP certificates
• Delegation of duties list (draft)
• Training history

The PI must demonstrate:

• genuine interest in the study
• adequate time availability
• experience in managing trials
• leadership of the research team

C. Patient Load & Recruitment Feasibility

Sponsor will evaluate whether the site has sufficient patient pool.
CRC prepares:

• OPD & IPD patient volume reports
• historical patient databases for the indication
• pre-screening sample lists (no patient contact yet)
• recruitment strategy draft

Example evidence:
For a Rheumatoid Arthritis trial—OPD register showing 80–100 RA follow-ups/week.

4 Step-by-Step SQV Workflow

• CRC receives SQV agenda → prepares documents
• CRC briefs PI and team
• CRA evaluates facilities
• CRA discusses protocol with PI
• Patient load feasibility presented
• Review of previous audit history
• CRA completes SQV report
• Site is selected or rejected