OpenClinica Integration with caAERS, a caBIG Application for Adverse Event Reporting

First, here’s a quick summary of caBIG. caBIG is an NCI sponsored initiative which makes essential tools and data accessible to the cancer research community worldwide. The infrastructure developed by caBIG primarily enables the collecting, analyzing, integrating, and disseminating information associated with cancer research and care. This cutting-edge technology will help scientists and practitioners develop find better means for cancer prevention and treatment.

caBIG has already developed a wide variety of tools. These tools include various software tools, database technologies, and Web-based applications. One of these web applications that is currently under development is caAERS. caAERS is an open source web application designed to collect, process, and report adverse events that occur during clinical trials. This web application takes a rule-based approach to decide whether any particular adverse events needs expedited reporting. Once the decision has been made caAERS makes it a priority to show the user the required data needed for each report that will be sent. You can learn more about the features of caAERS by visiting it’s home page .

So what might key integration points of the OpenClinica EDC system and caAERS be? For this integration to be possible, caAERS needs to be supplied with three things:

  1. Study data
  2. Subject data
  3. Adverse Event data

OpenClinica facilitates configuration and management of studies and research subjects, covering our first two data requirements. OpenClinica can also be used to collect Adverse Event data during patient visits. So how could this data collected in OpenClinica be transferred to caAERS, especially since caAERS might replicate some of the data fields?

The OpenClinicaEDC platform provides an innovative and direct approach for defining Case Report Form data elements via a structured spreadsheet template. Using this approach, we can design a CRF that includes all the data elements needed by caAERSand collect this data in OpenClinica, meeting caAERS’ third data requirement. During the course of the study, we can transfer the data between OpenClinica and caAERS using the export and import tools already provided by both systems.

The approach described above is one way of integration. Since both systems are open source, modules could also certainly be added to either OpenClinica or caAERS to provide real-time integration between both systems.

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