Guides
Guides
Longer pieces for the questions that come up in every feasibility call and IRB meeting. Each guide states the rule or the number, cites where it comes from, and ends with what to do differently on Monday.
Which guides are available?
How sponsors choose sites, and what they checkWhat sponsors check during site selection, and how a site can show enrollment, start-up and patient-count evidence.Read How to reduce screen failure at your siteBenchmarks by therapeutic area, root causes, and a pre-screening routine that cuts avoidable screen failures.Read How to win more studies as a siteThe levers a site controls to get selected for more studies, with benchmarks, a lever table and a plan for this week.Read IRB and HIPAA rules for patient outreachWho may contact patients, under which HIPAA path, with what IRB approval, and how TCPA and state AI laws apply.Read Pre-screening vs screening: where consent draws the lineDefinitions from FDA, NIH and ICH, what can happen before consent, how screen failures are counted, and what to log.Read Using your EHR to find trial patientsStructured data versus notes, HIPAA paths, cohort queries, LLM screening, coordinator review and the metrics that matter.Read What a long informed consent form costs youThe evidence on consent form length, reading level, comprehension and dropout, plus the fixes that work and how to measure them.Read
Where else can I look?
The glossary defines the terms these guides use. The templates turn several of them into documents you can fill in. The blog covers narrower topics as they come up.