A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates
Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses’ Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators.
Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events.
Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size.
Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.
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