Study and Site Management
Making a site run and a study finish
Site management spans feasibility and selection through activation, conduct and close-out. At feasibility you assess patient pool, competing trials, equipment, staffing and regulatory turnaround; at selection you confirm the site can recruit to target and comply with the protocol. Startup requires an executed contract and budget, IRB/IEC approval, essential document collection, staff training on protocol and systems, and investigational product receipt verified against the pharmacy manual. Site activation is the gate before any screening.
Budget mechanics matter for money questions: per-participant payments, per-procedure fees, pass-through costs such as imaging, and overhead or startup fees behave differently, and invoicing typically follows completed visits rather than promised ones. Recruitment and retention plans should be specific - referral pathways, IRB-approved advertising, reminder systems, travel reimbursement - and tracked with metrics such as screen failure rate, enrollment rate and reasons for dropout.
Close-out includes final monitoring, reconciliation of investigational product, resolution of outstanding queries, record retention notification and return of materials. Throughout, site and sponsor share responsibility for quality but not identical responsibilities: the site generates and maintains source records; the sponsor oversees.
Trap: a scenario describing a fully enrolled study with a stack of open queries, asking whether it can close. Enrollment is not completion - query resolution and database lock come first.
Rule of thumb: build a visit-by-visit site calendar and put every obligation on a date, because questions hide a missed obligation inside a plausible narrative. Worked example: a site that screens participants before IRB approval has created a deviation that may invalidate those data and is reportable, regardless of strong recruitment numbers.