During Clinical Trials there is always the potential of risk. such as immediate biasing in the trial groups from either the patients or the actual doctors conducting the tests. Several trial groups are created, a placebo, blind and a controlled to name a few, each that patients are selected through randomization. In addition, another reason that could pose a risk to the clinical trials is the well-being of the participants caused by adverse effects and death from the drug or medical device in question. Any adverse effects or risk that is known or discovered must be reviewed and proper procedure needs to be followed. these include filling out an IDE which will be submitted to the IRB and FDA. Depending on the severity of the compromise, the FDA will either reject or allow for correction.

Who is responsible? That would be the clinical trial coordinator. If the issue was known information, the investigators and monitors will be at fault along with the coordinator and ultimately the sponsor.