Study Preparation and Site Qualification
Before a protocol can be executed, the sponsor must determine whether a site can and will perform it. Know the documents: protocol and investigator's brochure (or package insert), feasibility questionnaire, site selection and pre-study (qualification) visit report, investigator CV and medical licences, Form FDA 1572 for IND studies, financial disclosure, laboratory certifications and normal ranges, and the site's IRB and contract status.
What you are verifying
- Investigator suitability - ICH E6 4.1.1 requires qualification by education, training and experience, plus adequate time. Sub-investigators and coordinators are assessed on the same criteria.
- Resources - staff ratios, competing trials, recruitment access to the target population, equipment, storage space, and pharmacy capability.
- Facilities - locked, temperature-monitored investigational product storage; secure records; calibrated equipment; centrifuges and freezers with logs.
- Laboratory - CLIA certification (or equivalent) for any lab generating data used for eligibility or endpoints; normal ranges and accreditation dates on file.
- Administrative readiness - budget, indemnification, confidentiality agreement, delegation plan, IRB turnaround.
Traps
- Qualifying a site on enthusiasm alone when the protocol demands washouts, biopsies or rare genotypes the site cannot deliver.
- Treating the Form 1572 as a contract or as necessary for every study (it applies to IND/IDE-regulated research).
- Confusing the site qualification visit with the site initiation visit: qualification happens pre-selection; initiation happens after approvals and precedes first enrolment.
- Missing expired certifications or normal range documents that invalidate already-collected lab data.
Worked example: a site proposes a single coordinator for a 60-subject oncology trial with 12-visit schedules. The qualification report should flag this as a resourcing risk and require a written staffing plan, because E6 puts responsibility for adequate resources on the investigator - and a monitor who documents nothing has effectively accepted the risk.