Rule CG-RES-001
Research recruitment: what rule CG-RES-001 checks
Rule CG-RES-001 is one of the checker's research recruitment rules. It cites 21 CFR 312.7(a), 21 CFR 812.7(d) and more. The reason, source and safer wording are below.
CG-RES-001 · Blocks approval · Citation checked against stored text
A recruitment ad must not say or imply the study drug or device is safe or effective for what is being studied, or equivalent or superior to another treatment. That is also a violation of the rules on promoting investigational products.
Source: 21 CFR 312.7(a); 21 CFR 812.7(d); FDA information sheet "Recruiting Study Subjects" (IRBs review advertising for recruitment); 21 CFR 56.111(a)(3)
Safer wording: Say what the study is testing ("this study is testing whether the drug is safe and effective") without saying or implying that it is.
21 CFR 312.7(a), 21 CFR 812.7(d), 21 CFR 56.111(a)(3) · Needs counsel review
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