Annual Reviews and Financial Disclosures

Abstract

The annual review is a good time to take stock of how a study is progressing. Assessment of the number of subjects, their ages, gender, race, and ethnicity should be reviewed. It is important to recognize if there has been any disproportionate recruiting of subgroups. Special attention should be given to any vulnerable or disadvantaged subjects who were enrolled. Issues with obtaining informed consent should be rigorously reviewed and any corrective actions taken and reviewed with all staff. Other important information includes information about subject injuries, subject complaints, subjects withdrawn due to complications from the study, and any subjects who voluntarily withdrew their consent for participating in the study. Finally, all staff members will complete a conflict of financial interest for each study yearly.