The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC...

IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.

ICH E6(R2) 3.1.2:The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.

21 CFR 56.111(a)(3):Requires equitable subject selection, which extends to advertisements and recruitment.

FDA Guidance on Recruiting Study Subjects (1998):States that “advertisements and recruitment materials must be reviewed and approved by the IRB prior to use.”

While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.

Correct answer:C (Recruitment materials).