Janet Donegan, ANP-BC, AOCN

Research documentation is a critical aspect of running a clinical trial. Key patient information such as informed consent, adverse events (AEs), concomitant medications, and medical and surgical histories are collected and used to determine patient safety and efficacy as the trial proceeds. Ultimately, the sponsor may make decisions—ranging from modifying the dose of the investigational drug to closing the study due to AEs—based on the data collected.