Every research site has a folder of past monitoring reports and a working sense of how things are going. Few sites have the same one-page picture a sponsor is building the moment a feasibility questionnaire lands: a score across the specific domains that decide whether a site is actually trial-ready, before the study ever starts.
217
real sponsor site qualifications analyzed to build the 6-domain readiness framework (JCTS, 2023)
40
discrete readiness practices identified across the six domains
What site readiness measures that feasibility does not
A feasibility assessment is study-specific. It asks whether this protocol, at this site, in this location, can hit its enrollment target. Site readiness is different. It is the operating capacity a site carries year round, independent of any one study: staff qualifications, infrastructure, quality controls, and safety processes that a sponsor checks before they even get to the protocol-specific questions.
A site can be highly feasible for one study and still fail on readiness, thin documentation, an expired GCP certificate, no audit trail on the EDC system, and never get invited to submit a feasibility questionnaire in the first place. Readiness is the gate before the gate.
Roughly 37% of sites miss their own enrollment target (Credevo), and a meaningful share of that gap traces back to readiness problems that had nothing to do with the patient population. Readiness is what a site controls before feasibility is ever asked.
The six-domain framework, built from 217 real site qualifications
A 2023 framework published in the Journal of Clinical and Translational Science analyzed 217 trial site qualification documents pulled from 50 sources across 14 sponsors, 8 pharmaceutical companies, 3 CROs, 2 government agencies, and one academic institution. The goal was to find what sponsors actually check, strip the redundancy, and organize it into a single reference. What came out is six domains covering 40 individual practices.
Research team (4 practices)
PI and sub-investigator credentials, team diversity, and current GCP training records. This is the domain sponsors check first and revisit least, until a finding forces them to.
Infrastructure (12 practices)
Facilities, equipment, drug storage, and reliable operational systems, from power and internet to secure temperature monitoring. The largest domain by practice count, and the one most sites treat as a checkbox rather than a differentiator.
Study management (9 practices)
Protocol execution, recruitment strategy, sample handling, and investigational product management. This is where a site's actual enrollment engine lives, and it is the domain most connected to whether a study finishes on time.
Data collection and management (5 practices)
Audit trails, system validations, electronic signatures, and documentation controls across every system a site uses to capture trial data.
Quality oversight (3 practices)
Process controls and continuous improvement practices that keep the site in regulatory compliance. The smallest domain by practice count, and the one covered in detail below.
Ethics and safety (7 practices)
Informed consent, IRB oversight, adverse event reporting, confidentiality protections, and engagement practices for vulnerable populations.
Every question in a feasibility questionnaire maps back to one of these six domains, whether the sponsor names it that way or not.
Turn readiness into a specific enrollment number.
The free feasibility report models your enrollment funnel and projected cost per randomized patient for a specific NCT number and location, so readiness translates into a number you can defend.
Get a Free Feasibility ReportThe domain most sites underrate
Quality oversight holds only 3 of the 40 practices in the framework, the smallest domain by a wide margin. It is also the one that ends site relationships outright. A single adverse audit finding in this domain can disqualify a site from a study regardless of how strong the other five domains are.
Sponsors weigh quality oversight out of proportion to its size because it is the domain that signals whether problems in the other five ever get caught and fixed before they become findings. A site with weak infrastructure but strong quality oversight self-corrects. A site with strong infrastructure and weak quality oversight accumulates issues until a monitor catches them all at once.
Score your site across all six domains
Rate your site 1 to 5 on each domain. The scale is deliberately simple: it is not a substitute for a sponsor audit, it is a way to find your weakest domain before a sponsor does.
Score 1 to 2: no documented process. The practice happens informally, if at all, and nothing is written down. If a monitor asked for evidence today, there would be none to hand over.
Score 3: functional but undocumented. Staff know how it works and it generally gets done, but there is no current document a sponsor could review without a scramble to assemble one.
Score 4 to 5: documented, current, and ready to hand over. A sponsor or CRO could request evidence for this domain today and receive it same day, current and complete.
A site scoring below 4 on any domain has a readiness gap a sponsor will eventually find, whether or not the site finds it first. The self-assessment is only useful if the score changes what the site does next.
Closing the gaps before the next questionnaire arrives
Readiness is not a one-time project. It is a standing packet, one owner per domain, refreshed on a fixed schedule instead of assembled under deadline pressure.
Assign one owner per domain
Six domains, six named owners. A domain with no owner is a domain that drifts until an audit finding forces attention.
Refresh on a quarterly cycle
GCP certifications, staff CVs, and equipment logs expire on their own schedule. A quarterly review catches lapses before a questionnaire does.
Keep quality oversight evidence separate
Given how disproportionately this domain is weighed, its documentation should never be buried inside a general operations folder. Keep it visible and current on its own.
Re-score before every questionnaire, not after
A pre-submission re-score catches the domain that slipped since the last study, while there is still time to fix it.
A site with a current readiness packet answers any feasibility questionnaire in hours instead of weeks. The same discipline is what makes a full feasibility assessment faster to run the next time a study comes across the desk.
Readiness compounds the same way enrollment forecasts do
Sites that score well across all six domains are not lucky. They built a system that keeps every domain current without a scramble, and that system pays out every time a new questionnaire lands. The site that answers same day, with evidence, is the site that gets the next call.
Clinical Enroll has delivered randomization across 30+ indications at an average of $1,588 per randomized patient across six published case studies, and the pattern behind those results starts with the same discipline: a site that can prove it is ready, before anyone asks.
Phase 3, vTv Therapeutics T1D
$2,500 CPP
8 randomized across three site locations · $20,000 investment
Read the case studyPhase 1/2a, Blue Lake Biotechnology RSV
$4,285 CPP
7 randomized across three site locations · $30,000 investment
Read the case studySources: Journal of Clinical and Translational Science, 2023 (six-domain site readiness framework analyzed from 217 sponsor site qualifications); Credevo (site enrollment target statistics); Clinical Enroll (first-party CPP data from published case studies, clinicalenroll.com/case-studies).