Raissa Canales is a Quality Auditor for the Clinical Trials Unit at NINDS. Dr. Canales joined the group in January 2023, she is dedicated to ensuring that all clinical trials meet the highest standards of quality, integrity, and patient safety. As a quality auditor, she closely reviews protocols, data, and procedures to identify any deviations, inconsistencies, or potential risks that could impact the validity of the trial results or the well-being of the study participants.
Dr. Canales completed medical school in 2014 at the Universidad Nacional Autonoma de Honduras receiving her Doctor in Medicine and Surgery degree. She practiced medicine for a year prior to starting her postdoctoral fellowship at the Liver Diseases Branch- NIDDK and working as a fellow on a clinical trial for viral hepatitis, AIDS and gastrointestinal disorders.
Some of the responsibilities of her position as a Quality Auditor include reviewing protocols and study documents by carefully examining the trial protocols and all related study documents to ensure that they are scientifically sound, ethically conducted, and in compliance with regulatory requirements. Verifying that the study design, inclusion/exclusion criteria, endpoints and data collection methods are appropriate and aligned with the study objectives. Performs regular audits to assess the compliance of the clinical trial processes with established protocols, standard operating procedures, and regulatory guidelines. Reviews the trial site’s documentation, data collection methods, informed consent procedures, and adherence to Good Clinical Practice guidelines. Identifies any deviations or non-compliance issues during the auditing process. Collaboration with the study team and investigators to rectify deviations promptly and ensure that corrective actions are implemented to prevent recurrence. Examine the impact of deviations on trial data and make recommendations for data integrity. Review adverse event reporting, to ensure that potentials risks and adverse events are properly documented, reported and managed in accordance with regulatory requirements. Actively participates in quality improvement initiatives by providing feedback and recommendations for process enhancements contributing to the overall ongoing improvement of clinical trial processes and ensuring the highest level of quality in research.