The Research Chart

Abstract

The purpose of the research chart has expanded considerably in the past decade due to advances in data-processing technology and the regulatory agencies’ desire for extensive documentation of subjects’ eligibility and clinical course in a study. The data that sponsors are collecting now on all patients with exposure to a study drug require highly standardized record keeping compatible with sophisticated computer technology. The advent of this standardized computer-compatible CRF has ruled out using the CRF as a comprehensive record of a patient’s course of study. The research chart has evolved as a separate record that contains all of the details of adherence to the protocol. It also links patients to the previous care they received prior to the study and their later reentry into the medical care system following the study. This record assumes increasing importance in supporting the authenticity of the research data now that subjects have begun to take part in studies at facilities at which they have no history of previous treatment. In fact, the proposed FDA regulations governing the obligations of clinical investigators (21 CRF Part 54) require that case histories of a patient’s eligibility and course of therapy be developed independent of the CRF to support the integrity of the data-collection process. Thus, the research chart has become perhaps the single most useful research document generated on a patient’s clinical course of study. Table 32 lists the materials that are included in such a chart.