CITI Training Practice Exam

Which guideline requires IRB/IEC to review a wide range of trial-related documents, including informed consent form updates and safety information?

1. FDA

2. ICH

3. Both FDA and ICH

4. Neither FDA nor ICH

The correct answer is: ICH

The International Council for Harmonisation (ICH) requires that IRB/IEC review a wide range of trial-related documents, including informed consent form updates and safety information. This includes the review of study protocols, investigator's brochures, serious adverse event reports, amendments to the protocol, and annual progress reports. Option A, FDA, is incorrect because while the FDA does require IRB/IEC review of certain trial-related documents, it does not specify a wide range or mention informed consent form updates specifically. Option C, Both FDA and ICH, is incorrect because while both agencies may require IRB/IEC review, the specific guideline that requires a wide range of trial-related documents to be reviewed is from the ICH, not the FDA. Option D, Neither FDA nor ICH, is incorrect because both the FDA and ICH require IRB/IEC review of