A Pre-study Visit (PSV) is an early on-site or remote assessment of a potential clinical investigational site, conducted before the final selection or activation. Its purpose is to realistically assess feasibility, resources, processes and risks before the sponsor or CRO formally confirms the site for the trial and contractually activates it.
Objective: feasibility and risk assessment
The central question of a PSV is whether a site can practically implement the trial: is there a sufficient number of patients, are the relevant diagnostic and treatment pathways in place, and is the team (including deputies) actually available? Unlike a Site Initiation Visit, the focus is less on training and more on a robust assessment of the baseline situation and local conditions.
For multicentre trials, the PSV is an important tool for making site selection more objective. It complements a feasibility study with a genuine assessment of processes and infrastructure, and helps to identify typical later problems – such as protocol deviations, delays to the First Patient First Visit, or unexpected recruitment bottlenecks – at an early stage.
Content and checkpoints of a Pre-study Visit
The agenda varies depending on the indication, trial design and complexity, but frequently includes a structured walkthrough and interviews with the relevant roles. Typical checkpoints are:
- Team and role clarification (investigator, deputy, study coordination, documentation lead) including experience with similar trials and training status.
- Patient pathway and recruitment process: screening sources, referrers, competing trials, expected screen failure rate, and realistic recruitment forecasts.
- Infrastructure check: storage, refrigerators, temperature monitoring, emergency procedures, laboratory logistics and sample shipment.
- IT and data processes: experience with Electronic Data Capture, handling of queries, local source documentation, and interfaces with laboratory or imaging systems.
- Quality and compliance aspects: SOP availability, archiving, handling of consent documents (Informed Consent Form), data protection, and role-based approvals.
Depending on the trial, suitability for special procedures is also assessed, for example imaging, biomarker samples, or the handling of decentralised elements such as remote monitoring, telemedicine visits, or eConsent. In drug trials, the local pharmacy may also be involved to verify processes for receiving, storing, dispensing and returning investigational medicinal products.
Another practical point is the involvement of external service providers at the site, such as central laboratories, radiology partners, or courier services. Where interfaces here are unclear, deviations frequently arise later (e.g. delayed sample processing or incomplete imaging documentation). During the PSV, these interfaces can be discussed concretely and responsibilities established.
Documentation, decision criteria and follow-up
A PSV is only valuable if it is documented in a traceable manner. PSV reports with an assessment, risk indicators and clear action items are common. Many projects use a traffic-light logic (“suitable”, “suitable with conditions”, “not suitable”) and define minimum requirements, for example regarding staff availability or infrastructure.
Common errors include overly optimistic recruitment assumptions or overlooking organisational bottlenecks, for example where study coordination is only partially available or processes depend heavily on individual staff members. A structured follow-up with responsibilities and deadlines is therefore essential so that findings actually feed into Study Start-up, monitoring planning and risk analysis.
Relevance for clinical trials
The PSV is part of a risk-based quality approach: the earlier risks are identified, the less costly later corrections become. Findings from the PSV often influence central trial planning, for example the operationalisation of visit schedules, the design of risk-based monitoring, or the decision to activate additional sites.
The PSV is particularly relevant for trials with tight timelines or complex procedures, for example demanding imaging, specialised laboratory analyses, or high requirements for trial logistics. If a dependency is overlooked here during planning (e.g. sample shipment only possible on certain weekdays), this can later impair data generation and patient safety. A PSV provides the information needed to make process adjustments at an early stage.
For CROs, the PSV is also an opportunity to calibrate collaboration realistically. A well-conducted PSV creates transparency and increases the likelihood that the site will recruit steadily after initiation and reliably deliver data quality and patient protection. At the same time, it supports the evidence that the sponsor and CRO have appropriately fulfilled their selection and oversight responsibilities.
Frequently Asked Questions (FAQ)
When should a Pre-study Visit be conducted?
Typically after an initial feasibility survey and before the final site selection or shortly before contract signature. For complex trials, an early PSV can help clarify infrastructure and staffing requirements in good time.
Can a Pre-study Visit take place remotely?
Yes, many content areas can be covered by videoconference and document review, particularly for established sites. For critical infrastructure points (e.g. storage conditions, sample pathways, equipment), an on-site visit is often still advisable.
Which findings feed into the decision for or against a site?
Decisive factors are realistic recruitment capability, availability of the team, experience with GCP, robust data processes, and the expected risk of deviations or delays. These factors are usually consolidated in a PSV report and integrated into the site decision.
Regulatory references
- ICH E6(R3) Good Clinical Practice: expects appropriate qualification of investigational sites and risk-oriented planning of oversight and quality.
- Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR): sets out sponsor responsibilities and requirements for conduct; implies the need to select and oversee suitable sites.
- ISO 14155:2020 (for clinical investigations of medical devices): contains requirements for site selection, qualification and documentation in the context of medical device trials.