Choosing IVD study sites: a practical feasibility review

Give every candidate site the same study brief

Describe the intended purpose, specimen, population, required reference information and proposed testing workflow. Include enough detail for the site to assess practical feasibility without requesting unnecessary identifiable participant information. When key design elements are still open, label them as assumptions and ask what difference they would make.

A standard brief makes responses comparable. Otherwise one site may estimate all samples processed by its laboratory, while another reports only specimens satisfying the proposed criteria. The resulting figures look comparable in a spreadsheet but describe different opportunities.

Separate gross volume from evaluable specimens

Work through the likely losses between incoming specimens and analysable records: eligibility, volume, stability, required reference data and operational availability. Ask which estimates come from existing records and which are judgement. For a rare subgroup, a large overall volume may still yield very few suitable specimens.

Do not ask sites to promise recruitment merely to make a schedule fit. Document a plausible range, the observation period supporting it and conditions that may change it. Where several sites use the same referral source, check whether their estimates overlap before adding them together.

Review the whole specimen and data pathway

A specimen may be available but unusable for the planned endpoint if the relevant clinical or reference information cannot be obtained. Similarly, a technically capable laboratory may lack the staff capacity or storage arrangement needed for this study. Review both scientific suitability and execution.

Test the handover before the first study specimen

Use a fictional record to test identification, receipt, testing and data capture. Add a missing field or invalid result and check whether the site knows how to record and escalate it. The purpose is to reveal a workflow gap, not to generate performance evidence or replace required approvals.

Where testing is centralised, identify who confirms eligibility and who retains the underlying record. Define what happens when transport conditions are outside limits or specimen information is incomplete. Clear responsibilities make exceptions easier to resolve without losing traceability.

Keep selection and activation as separate decisions

Record why a site was selected, its limitations and the conditions still to be met. Selection may be reasonable while a contract, training activity or other requirement is still outstanding. Activation should depend on documented readiness, not on the fact that the site appears in an initial plan.

After activation, compare actual availability, query volume and workflow problems with the feasibility assumptions. Investigate changes before they become schedule failures. Add capacity or revise arrangements through the appropriate study controls rather than changing eligibility informally to improve recruitment.