PharmaTimes International Clinical Researcher of the YearFraud & Misconduct in Clinical StudiesStage 2 Essay Challenge QuestionFraud and misconduct in clinical studies can be challenging to detect! What tools and techniques could you use on-site and off-site to identify potential fraud and misconduct. What could lead you to suspect fraud/misconduct when monitoring? What steps would you take if you suspected fraud and misconduct at site?IntroductionClinical trials have become an integral part of healthcare, redefining tomorrows standard of care; thus, much weighs on their data and results. Despite heavy regulation (1, 2), data falsification and fabrication continues (3, 4). Monitors must be able to detect the signs of possible fraud and misconduct (F&M).Fraud Vs MisconductIntent to deceive distinguishes fraud from misconduct; fraud is considered a deliberate deception for personal gain (5), whereas misconduct is unintentional. In both instances, the safety of subjects and the reliability of data is jeopardised.Fraud can broadly be classified as the (6):-          fabrication (i.e. creation) ofdata (e.g. patient identities, physical examinations, biological specimens)documents (e.g. ICFs, diaries, scan reports)-          falsifying data (i.e. altering or omitted existing records)Misconduct is serious or repetitive failure to comply with the study protocol, GCP and regulatory requirements. Examples include inadequate staffing, poor attention to detail, lack of understanding of regulatory requirements and poor management. Although unintentional, it can falsify the data.Tools & Techniques to Identify the Warning SignsGCP dictates that sponsors must monitor their clinical trials, as it facilitates data accuracy, integrity and completeness (7). Monitors may face ominous signs, such as significant differences or implausible trends at one site or of all patients under the care of a single investigator would (8, 9), requiring vigilant investigation.