New CRC here, trying to ramp up enrollment: trivia check — what’s the actual rule on texting pre-screened patients about a study — does that count as advertising needing IRB review, or is it considered outreach under our HIPAA waiver? I’ve got 23 prescreen calls lined up today and want to do this right…
Does your waiver explicitly allow text? If the message invites them to a specific study, treat it as recruitment material — think of it like a billboard in their pocket — and get the exact SMS IRB‑approved; the waiver lets you use PHI to contact but doesn’t replace IRB review. Add opt‑out language and use the approved texting platform; quick ref: FDA guidance Recruiting Study Subjects | FDA.