Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data

A working example to showcase the Food and Drug Administration’s guidance on electronic source data in clinical investigations.
Agency
  • Food and Drug Administration (FDA)
Start Date
  • 9/1/2016

 

Functionality
  • Standardized Collection of Standardized Clinical Data
  • Use of Clinical Data for Research

 

STATUS: Active Project

BACKGROUND

As clinical research and clinical trials data are now mostly collected through electronic health records (EHRs) and electronic data capture (EDC), there is a need to develop a guideline or protocol for the use of health care data use in clinical research and trials. In 2013, the Food and Drug Administration (FDA) published guidance on Electronic Source Data in Clinical Investigations, which provides recommendations on the capture review and retention of electronic data in FDA‑regulated clinical trials. However, the recommendations have made little impact in the stakeholder community. To provide a working example of the FDA’s recommended approach, the FDA has initiated this project, which will provide a real world demonstration of their guidelines and commitment to EHR‑to‑EDC in clinical research environments.

PROJECT PURPOSE & GOALS

This project will create a single point data capture approach from the EHR to EDC systems using the Retrieve Form for Data Capture (RFD) standard.

The project objectives are to:

  • Demonstrate an end‑to‑end, EHR‑EDC, standards‑based technology solution for the capture and transmission of regulated clinical research data.

  • Assess the value of the standards‑based technology solution processes for FDA inspection and reconstruction of clinical investigations.

  • Assess the impact of the standards‑based technology solution on current processes at the sites, and on remote monitoring of the study.

  • Develop guidelines for future implementations in both health care and clinical research.

  • Provide recommendations for the improvement of existing standards and implementations including standards‑development organizations and structured data capture (SDC).

  • Develop a general framework (technologies, processes, policies, governance, and standards) for the use of electronic SDCs in regulated clinical trials.