Photographic Documentation by Mobile Devices Integrated into Case Report Forms of Clinical Trials

Abstract

Subject’s medical data in controlled clinical trials is captured in electronic case report forms. We present a mobile application (App) that utilizes the smartphone-integrated camera for integrating photographic documentation directly from subject’s bed-side. Color reference cards are placed next to the wound and used for geometric and contrast registration. This ensures high image quality with the inexpensive consumer hardware. In addition, a code is detected from the card for subject identification. The App connects to an image analysis server and looks up the code-study-subject relation. Then, the smartphone connects with OpenClinica, an open source and electronic data capture system for clinical trials, which has been approved by the US Food and Drug Administration (FDA). The App is demonstrated by an ongoing clinical trial, where wound healing after a vascular surgery is followed up photographically. All 205 images collected in the study so far have been identified and integrated into subject’s eCRF correctly. Avoiding manual mapping of photographs to study subjects avoids errors and latency, decreases costs, and improves data security and privacy.