Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research

Abstract

Introdution: For a clinical trial to be properly, safely and efficiently conducted, it is necessary that research integrity be preserved. Therefore, some specific information is essential, including events or adverse reactions. Objectives: To analyze the degree of reliability and completeness of medical records in relation to medical and nursing records according to selected aspects of the events or adverse events experienced by the research subjects; to verify the existence of start and end dates of events or adverse reactions reported by doctors; to observe the presence of graduation of events or adverse reactions in medical reports; to notice if there is data in medical records that relate the events or adverse reactions to the investigational drug; to identify the degree/rate of agreement between the physician and nurses reporting in the records of events or adverse reactions. Method: Documental, exploratory and descriptive study. The sample consisted of 40 charts of patients enrolled in the Brazilian National Cancer Institute who participated in clinical research protocols between 2005 and 2006. Results: 828 events were identified and only 1.5% of those which were recorded by research professionals had start and end dates, graduation, and relationship/causality; 30.3% of events were recorded in conformity by nurses and doctors. Conclusion: There are many reasons why adverse events are not efficiently captured, but efforts are needed to improve quality of clinical trial data and compliance with regulatory requirements aiming to protect research subjects.