Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices, such as contaminated drugs or vials that are being used during the studies. Thus, risks of contaminating materials intended for use in patients can suspend the facility or as the previous student mentioned, it can put a “pause” on the study. Additionally, all known risks must be fully explained by the researchers before the trial begins, but if new risk information becomes available during the trial and it is not explained to the participant, this can affect whether or not the clinical study stays active. Overall, I believe that the manufacturer will be the responsible party for not completing the proper due diligence of making sure that everything is running smoothly before and during the study.