Site Feasibility, Startup & Management
Selecting countries and sites, activating them, agreeing contracts and budgets, confirming they are genuinely ready, and supporting them for the duration. Sites are independent organisations with their own pressures, competing studies and staff turnover. A site activated before it is ready produces the deviations that consume the rest of the study, and the pressure that activated it early is always schedule.
What an explainer is not
A topic explainer is SPEQ’s synthesis of what a practice involves, cited to the standards that govern it. It does not reproduce their text, and it does not determine which of them apply to your product or process.
[ POSITION IN THE FRAMEWORK ]
7 DIMENSIONS · 20 LINKSFeasibility is where recruitment optimism enters a programme and stays: sites are selected on projections nobody revisits, and the resulting rescue is more expensive than the selection was.
06 · QUALITY MATURITY — SITE FEASIBILITY, STARTUP & MANAGEMENT, REACTIVE TO ADAPTIVE
Sites are selected on relationships and stated interest. Startup takes as long as it takes.
A feasibility questionnaire is issued and sites are chosen on projected enrolment, which is not compared against what they subsequently deliver.
Selection uses verifiable capability — actual population, prior performance, staffing, systems — and startup steps are tracked with the bottleneck known.
Sites are monitored on performance and data quality rather than on visit completion, and support is targeted at the sites the data says need it.
The site network is a managed asset: past performance informs future selection, and the same sites get better across studies rather than being rediscovered.
SPEQ’s shared five-stage progression, labelled synthesis — not the FDA QMM rating scale. Where does your organization sit? Score your quality system →
07 · REGULATORY & EVIDENCE
GOVERNING STANDARDS · 4
Derived from the 4 standards SPEQ maps to this subject, across 3 regulatory bodies: ICH, FDA, EMA.
RECORDS & OBJECTIVE EVIDENCE
- Feasibility assessments with the verifiable basis for each site’s projection
- Startup milestone tracking, with the critical path identified
- Site qualification and training records, including delegation of authority
- Performance data per site: enrolment, deviations, data quality, query rates
- Records of actions taken where site performance diverged from projection
COMMON INSPECTION FINDINGS
- Sites selected on projections that prior performance contradicted
- Feasibility responses accepted with no verification of the population claimed
- Delegation logs that do not match who actually performed study procedures
- Site performance monitored by visit completion rather than by data quality
- Underperforming sites left active for the length of the study with no intervention
Feasibility that asks the right questions
Feasibility questionnaires reliably return optimistic answers, because sites are asked whether they could recruit a population and answer in good faith about a population they see. The questions that predict actual performance are narrower: how many participants matching these specific criteria did you see in the last twelve months, what competing studies are open for the same population, and who specifically will perform the assessments.
The recurring pattern is a study distributed across many sites of which a minority recruit meaningfully. That is expensive in a way that is easy to miss — every activated site carries the same startup cost, training burden, monitoring obligation and closeout work regardless of how many participants it enrols.
Readiness is a state, not a document set
A site is ready when the contract is executed, the ethics approval is in place, the staff who will actually perform the work are trained and delegated, the equipment is present and calibrated, the pharmacy or laboratory is prepared, and the systems are accessible. Activation frequently happens when the regulatory documents are complete and the rest is assumed.
The gap between those two is where early deviations come from: a delegation log completed after the first participant was seen, a coordinator trained on the protocol that was superseded, an assessment performed on equipment that was not qualified. Each is discoverable at activation with a specific question, and none is discoverable from a document checklist.
Oversight is a sponsor obligation, not a monitoring activity
ICH E6(R3) places responsibility for oversight on the sponsor, whether or not activities are delegated to a CRO. Delegation transfers work and not accountability — a sponsor that cannot describe how its CRO is performing, or that receives only summary metrics, is not exercising oversight it remains answerable for.
Risk-based approaches make this workable rather than optional. Concentrating monitoring on the critical data and processes identified in the protocol, using centralised statistical monitoring to detect site-level anomalies, and reserving on-site effort for where the risk actually sits, is what the framework asks for — and it is far more effective than a uniform monitoring visit schedule that treats every site as equally likely to have a problem.
SPEQ interpretation — turnover is the risk nobody plans for
Site staff turnover during a multi-year study is close to certain, and it invalidates several things at once: the training records, the delegation log, and the informal knowledge of how this protocol is actually run at this site. The new coordinator inherits a study nobody has time to explain, and the deviation rate moves before anyone connects it to the change.
The countermeasure is unremarkable and rarely operationalised: treat a change in key site personnel as a trigger for a defined re-onboarding, and monitor for it actively rather than learning about it from a delegation-log update three months later. It is the single most predictable source of mid-study quality drift.
FREQUENTLY ASKED
What makes a feasibility assessment predictive?
Specificity. Asking how many participants matching these exact criteria the site saw in the last twelve months, what competing studies are open for the same population, and who specifically will perform the assessments predicts performance. Asking whether a site could recruit returns optimistic answers given in good faith.
When is a site actually ready to activate?
When the contract and ethics approval are in place, the staff who will perform the work are trained and delegated, equipment is present and calibrated, pharmacy and laboratory are prepared, and systems are accessible. Activating on regulatory-document completeness alone is where the early deviations come from.
Does delegating to a CRO transfer the oversight obligation?
No. ICH E6(R3) places oversight responsibility on the sponsor whether or not activities are delegated. A sponsor receiving only summary metrics, unable to describe how its CRO is performing, is not exercising oversight it remains answerable for.
What is the most predictable source of mid-study quality drift?
Site staff turnover. It invalidates training records, the delegation log and the informal knowledge of how the protocol is run at that site, all at once. Treating a change in key personnel as a trigger for defined re-onboarding — and monitoring for it actively — addresses it; learning about it from a delegation-log update months later does not.