The independent read module is an integral part of the ERICA system. The read module combines a state-of-the-art DICOM image viewer (FDA-approved as a medical device) with an electronic CRF (eCRF). Images are automatically displayed to the reader as defined in the study protocol and/or Imaging Charter. The functionality of the DICOM viewer can be configured to ensure that only required functions can be accessed, and only required information is displayed on the images. If necessary for image interpretation, additional information can be selectively displayed to the reader (e.g., data from the clinical database like laboratory values). The eCRF allows programing of all types of consistency checks. The reading module includes the possibility to display results from assessments of previous images of the same patient, as well as the display of image analyses from different readers (e.g., for adjudication sessions). The available reader functionality allows a broad range of standard and non-standard image analyses, like assessments based RECIST 1.0/1.1, CHOI, lesion volumetry, multi-planar reconstructions, image segmentation, and others. Read results are electronically signed and stored in an electronic database. Read results are transferred to the sponsor in the agreed format (e.g., as SAS files).
pharmtrace’s proprietary software for independent reads (ERICA) combines regulatory compliance (21 CFR 11, GAMP 5) with the flexibility of up-to-date image visualization and analysis tools.