Site Qualification Visit (SQV)

A Site Qualification Visit (SQV) — also called a pre-study visit or site selection visit (PSSV/SSV) — is the assessment visit a sponsor or contract research organization (CRO) conducts at a prospective investigative site before deciding whether to select it for a specific clinical trial. Unlike a Site Initiation Visit (SIV), which activates a site that has already been chosen, contracted, and IRB-approved, the SQV happens earlier and answers a different question: should this site be chosen at all.

What the SQV evaluates

An SQV is a structured, in-person or remote evaluation covering several readiness domains. A site sponsor or CRO representative — typically a Clinical Research Associate (CRA) — reviews:

• Facilities and equipment: a tour of relevant spaces (pharmacy, laboratory, imaging, storage/freezer capacity, examination rooms) to confirm the site can physically support the protocol’s procedures.
• Staff qualifications and experience: the credentials, training, and prior trial experience of the principal investigator, sub-investigators, study coordinators, and research nurses who would be assigned to the study, consistent with the sponsor-selection standard in ICH E6(R2) Principle 2.8 (investigators qualified by training and experience) and, for US IND-regulated drug trials, 21 CFR 312.53(a).
• Patient population and recruitment feasibility: whether the site’s patient volume, demographics, and referral patterns can realistically meet the protocol’s enrollment targets within the study timeline.
• Prior study experience and regulatory history: the site’s track record on past trials — enrollment performance, protocol deviations, audit or inspection findings — and its familiarity with sponsor-required systems (EDC, IRT, safety reporting).
• Standard operating procedures and quality systems: whether the site has documented SOPs for source documentation, informed consent, drug accountability, and delegation of authority.

The site typically completes a feasibility questionnaire in advance, and the SQV itself confirms or probes further into what was reported on paper.

Where the SQV sits in the site-visit sequence

Clinical operations commonly sequences site-facing visits as follows — an established industry convention rather than a sequence defined verbatim by ICH E6 itself:

1. Site Qualification Visit (SQV) / pre-study visit — before contracting, evaluating whether to select the site.
2. Contracting and IRB/IEC approval — the clinical trial agreement, budget, and ethics approval are finalized for the now-selected site.
3. Site Initiation Visit (SIV) — confirms the contracted, approved site is ready to open and enroll.
4. Routine / interim monitoring visits — during active enrollment.
5. Close-out visit (COV) — after the site’s participation ends.

The distinction matters operationally: an SQV can result in a site NOT being selected, while an SIV is, by definition, a visit to a site the sponsor has already committed to. See CASRAI’s Site Initiation Visit checklist guide for what happens at the next stage, and the clinical trial site selection guide for the fuller selection process the SQV sits inside (candidate identification, feasibility questionnaire, desk review, SQV, selection decision).

Who is involved

A CRA or clinical operations lead from the sponsor or CRO typically conducts the visit. Site-side attendees usually include the prospective principal investigator, study coordinator, and relevant department staff (pharmacy, lab). Some sponsors also send a medical monitor for complex or high-risk protocols. TransCelerate BioPharma’s Site Qualification and Training (SQT) initiative is a related industry effort aimed at reducing duplicative per-sponsor qualification questionnaires and training requirements that sites otherwise repeat across trials.

Documentation

Findings from the SQV — along with the feasibility questionnaire — feed the sponsor’s site-selection decision and, once a site is chosen, become part of the trial’s essential-document trail alongside later SIV and monitoring records.