How to run a Pre-Study (Site Qualification) Visit

A pre-study visit, also called a site qualification visit, answers one question: can this site run the study safely and to the standard the protocol and the sponsor require? It happens before the site is activated and before any participant is enrolled. The visit is an assessment of capability, not a compliance audit, and it is not a rehearsal of the site initiation visit.

The CRA is testing whether the site has the facilities, staff, equipment, systems and patient population to deliver the protocol. That means looking at the practical route a participant will take through the site, the people who will do the work, the documents that must be in place, and the site's own account of how it will recruit and retain participants.

A good PSV is proportionate. A first-in-human study, a complex device trial or a study with a demanding visit schedule needs more scrutiny than a low-risk observational study. The CRA should use the protocol, the sponsor's feasibility data and any pre-visit questionnaire to decide where to spend time. The output is a recommendation: suitable, suitable with conditions, or not suitable. Many sites are suitable with conditions, and the value of the visit lies in identifying those conditions early, agreeing who owns them, and setting dates before the SIV.

The CRA should also remember what the PSV is not. It is not a substitute for the site's own feasibility review, and it does not transfer responsibility for GCP compliance to the monitor. The visit documents what was seen, what was not seen, and what the sponsor needs to decide. A short, well-evidenced report is more useful than a long report that repeats the protocol.

The document request should go out at least two weeks before the visit. Asking on the day turns a qualification visit into a document chase and makes it harder to judge whether the site is ready.

• Protocol synopsis and current investigator brochure, or the equivalent documents for the study design.
• Investigator CV and current GCP certificate.
• Draft delegation log showing the proposed study team.
• Site patient demographics and a recruitment estimate with its basis.
• Laboratory certifications, reference ranges and sample handling instructions.
• Equipment calibration certificates for study-specific equipment.
• Investigational product storage and temperature monitoring evidence.
• Pharmacy licence and dispensing arrangements.
• Ethics or IRB submission plan and expected approval timeline.
• Site SOPs for informed consent and source documentation.
• Contract and budget status, including any outstanding legal review.
• Any pre-study questionnaire or feasibility assessment already completed by the site.

• Temperature monitoring not calibrated or not continuous. A site may have a thermometer but no current calibration certificate, or may record temperatures only when someone remembers. The CRA should check the calibration date and the monitoring interval against the product label and the sponsor's requirements.
• GCP training expired for one or more staff. Training certificates are often filed but not reviewed. The CRA should check the date on every certificate for the staff who will touch the study, not just the investigator.
• No delegation log or no documented training before delegation. A draft delegation log is a simple document, but it shows whether the site understands task delegation. If staff are already doing study tasks without a log or training record, that is a finding to resolve before activation.
• Recruitment forecast with no basis. A number without a source is an assumption. The CRA should ask for the clinic data, referral pattern or historical enrolment that supports the forecast, and record the basis in the report.
• Laboratory reference ranges out of date. Reference ranges should match the laboratory's current methods and be dated. Out-of-date ranges create avoidable queries and can affect safety assessment.
• No defined consent process for non-English speakers. If the site expects to enrol participants who do not speak the local language, the consent process needs a validated translation and a documented interpreter arrangement. A blank space in the process is a finding.
• PI with conflicting commitments and no named deputy. An investigator who is stretched across too many studies may not be able to provide adequate oversight. The CRA should discuss the time commitment and confirm who will cover when the PI is unavailable.

The PSV report should separate evidence from opinion. If a document was not available, the report should say so. If the site stated something but did not demonstrate it, the report should distinguish the statement from the verification. The sponsor needs to know what was assessed, what was not, and what must happen next.

1. Is the site suitable, suitable with conditions, or not suitable?
2. What must be in place before the SIV, by whom and by when?
3. What is the recruitment forecast and its basis?
4. What risks does the sponsor need to know about now?

The qualification decision should reach the sponsor within the timeline agreed at the start of the feasibility process. A verbal recommendation at the end of the visit is useful, but the written record is what the sponsor will rely on. Critical gaps should be escalated immediately rather than held until the report is issued.

Every condition should be logged as a finding with an owner, a due date and the evidence that will close it. Conditions that are vague, such as improve recruitment, cannot be verified at the SIV. Conditions should be specific enough that a different monitor could check them.

The CRA should re-check the conditions at the SIV. If a condition is not met, the escalation should happen before enrolment begins, not after the first participant has been dosed. The sponsor may decide to delay activation, add a follow-up visit or decline the site.

The final PSV report and any supporting documents should be filed in the trial master file and the investigator site file according to the sponsor's document plan. The report should make clear which items were verified on site, which were self-reported and which remain open.