SOCRA CCRP Practice Exam Prep – Free Practice Tests & Study Guide

IRB oversight hinges on ongoing updates that show the study is still protecting participants and operating as approved. Attachments to research proposals documented by IRBs should include progress reports that detail how the study is progressing—enrollment status, data collection milestones, completion of study milestones, and any deviations from the protocol. They also cover safety and ethics aspects, such as adverse events or unanticipated problems, and any changes to the protocol or informed consent. These updates help the IRB determine whether continuing approval is appropriate and whether any actions are needed to protect participants.

Annual financial, auditing, or marketing reports don’t focus on the conduct of the human subjects research or participant safety, so they aren’t the type of attachments IRBs require for ongoing review.