It is therefore in the investigator's financial interest to enroll large numbers of patients quickly and retain them as long as possible. Thus, taking nothing else into account, clinical investigators have an undisclosed monetary interest in their projects that could lead them to commit acts of fraud. The worst examples of fraud include the researcher who invents patients, purposely enters otherwise ineligible participants, and alters or lies about medical assessments that might force a patient's early withdrawal from a study. Besides the fraudulent actions just mentioned, several research practices are blatantly illegal, including faking medical records, deliberately changing patient evaluations, purposely omitting adverse events, knowingly providing excluded medication to study patients, forging informed consent documents, and hiding instances of negligence. Commonly, investigators and their staff simply make errors in study conduct, such as omitting a significant adverse event from the case report form document.
All deviations are, in fact, violations that constitute negligence.
Investigators might argue that their actions did not harm any patients and therefore no real violation occurred, but the fact that patients were not harmed does not mean they couldn't have been harmed. In addition, the integrity of data from single-site studies is necessarily compromised by such errors, as is data from multisite trials if errors are compounded across investigative centers or occur at high patient enrolling sites, that is, individual sites that enroll large numbers of patients in a single clinical study. Therefore, all violations are significant and constitute negligence. This is not to say that the FDA would automatically discipline an investigator who accidentally provides an excluded study drug to a patient, such as marketed benzodiazepines to a patient enrolled in a trial of a novel anxiety medication. The study monitor will usually catch these errors early, ask the site to remedy them, follow up to confirm that action was taken, and document the violation and its remedy.