The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission. According to the ICH GCP Guidelines, which of…

ICH-GCP requires that any materials used to recruit or inform prospective subjects (e.g., advertisements, flyers, web postings) be reviewed and approved by the IRB/IEC before use. Section 3.1.2 states that the IRB/IEC “…should review… especially the written informed-consent form(s) and any subject-recruitment procedure (e.g., advertisements).” Recruitment materials are therefore an obligatory part of the submission package for a Phase III vaccine trial. The other listed documents are either not required for IRB/IEC review or are only filed with the sponsor and investigator.

A. Local laboratory normal ranges (ICH E6 8.2.11) are filed with investigator and sponsor; no IRB/IEC review required.

B. Blank CRFs may accompany the protocol (ICH E6 8.2.3) but are not specifically mandated for IRB/IEC submission and are seldom requested.

D. Investigator CVs (ICH E6 8.2.10) document qualifications for sponsor and site files; ICH does not require them to be sent to the IRB/IEC.

1. International Council for Harmonisation. ICH E6(R2) Good Clinical Practice Guideline. Section 3.1.2, p. 22; Section 4.4.3, p. 27; Section 8.2.7, p. 38.

2. FDA Guidance for IRBs, Clinical Investigators, and Sponsors: “Recruiting Study Subjects,” July 2018, pp. 2-3.

3. University of Michigan IRBMED Policy: “IRB Review of Advertisements and Recruitment Materials,” Rev. 2022, pp. 1-2 (illustrates standard application of ICH 3.1.2 requirements).