What documentation must an investigator provide to the IRB according to ICH?

The correct documentation that an investigator must provide to the Institutional Review Board (IRB) according to ICH guidelines includes advertising materials for subject recruitment. This is essential because the IRB's role is to ensure the ethical treatment of participants in clinical trials, which encompasses the methods used to recruit them. By reviewing the recruitment materials, the IRB can assess whether they are clear, accurate, and not misleading, thereby protecting potential subjects from coercion or undue influence.

In this context, advertising materials must comply with ethical standards and convey all necessary information, allowing potential participants to make informed decisions about their involvement in the study. Such oversight is a crucial part of the IRB's protective measures for human research subjects.

In contrast, evidence of financial compensation, trial results from previous studies, and statistical analysis plans are typically not required for IRB review as primary documentation. While these elements may be important in the overall conduct of research, they do not directly pertain to the process of ensuring the ethical treatment of study participants in the same way that recruitment materials do.