Today, subject’s medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs).
However, eCRFs only insufficiently support integration of subject’s image data, although medical imaging is looming
large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the
smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference
cards are placed in the camera’s field of view next to the lesion. The cards are used for automatic calibration of
geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification.
For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject
relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica,
an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials.
Once the photographs have been securely stored on the server, they are released automatically from the mobile device.
The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is
frequently performed to measure the effect of wound incision management systems. All 205 images, which have been
collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject’s
eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs
decreased. Our approach also increases data security and privacy.