About
Open Label Templates makes the documents clinical research sites actually need, built by people who run trials, not by a software vendor or a generic template mill.
Every site rebuilds the same notes to file, logs, checklists, and SOPs from scratch. We did too. So we built a complete, audit ready set, aligned to ICH E6(R3) good clinical practice and 21 CFR, and we keep it current as the guidance changes.
Who makes these. Created and maintained by Justin Yamashita, MSc, a working clinical research professional with hands on experience as a clinical trial coordinator and clinical research associate, plus global trial project leadership across Phase I, II, and III studies. The views here are our own and do not represent any employer or sponsor.
What makes them different. Built and tested across real clinical trial roles, from coordinator to monitor to global project leadership, so they match how sites and sponsors actually work. Editable Word and Excel, so your site or SMO can white label them and reuse them across every study. Written in plain language a new coordinator can follow on day one. A connected system that covers the whole site, from startup to closeout, not scattered single documents. Versioned and maintained, so you are never working from a stale file.
These are practical tools for research professionals. They are educational and operational templates, not regulatory or legal advice. Your site is responsible for final review against your protocol, sponsor requirements, and applicable regulations.