分子与遗传医学

Electronic Capturing of Genetic and Molecular Data in Modern Clinical Trials

Abstract

Tenti E, Manfrini M, Zavan B, Balla C and Ferrari R

Healthcare data continues to explode in size and complexity and collection and harmonization of disparate clinical, molecular, patient research and biospecimen data is key to effective research, but presents challenges in terms of access, organization, security and compliance. When designing an experimental clinical study, it is important to plan how genetic and molecular data will be collected and recorded in the course of the study. With the recent advent of internet of things (IoT) the direct recording of data could be widened to mobile devices such as wearable sensors which could capture biomedical information directly from patients’ body, and to other type of remote devices internet connected such as digital scales for body fat and weight monitoring. Despite the diffusion of the electronic data capture, paper collection data sheets are still widely employed. Electronic data capture (EDC) employs different technologies and methods for data collection. For these reasons EDC (electronic data capture) and eCRF (case report form) are becoming more widespread. Their production is complex and needs to comply with strict regulations both in Europe and in the United States, which comprise system validation, security policy and data backup.