Rule CG-RES-006
Research recruitment: what rule CG-RES-006 checks
Rule CG-RES-006 is one of the checker's research recruitment rules. It cites 21 CFR 50.20. The reason, source and safer wording are below.
CG-RES-006 · Warns · Citation checked against stored text
A recruitment ad should make clear it is about research and say the condition under study or the purpose. FDA treats the ad as the start of the informed consent process.
Source: FDA information sheet "Recruiting Study Subjects" (items an ad may include); 21 CFR 50.20
Safer wording: Say it is a research study, name the condition under study and the purpose, and give a location and contact for questions.
21 CFR 50.20 · Needs counsel review
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